1、Pipeline assets and clinical trials appendixQ1 2025Infectious disease2ContentsInnovation:Pipeline growthClinical trialsRespiratory,Immunology and Inflammation(RI&I)OncologyHIVInfectious DiseasesInfectious disease3Innovation:Pipeline growthOverview of potential new vaccines and medicinesHIVHIVOncolog

2、yOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossaryInnovation:Pipeline growthRIIRI&IRI&IOncologyHIVInfectious DiseasesPhase III/RegistrationPhase III/Registration18)camlipixant(GSK5464714)P2X3 receptor antagonistRefractory chronic coughdepemokimab(GSK3511294)Long-acting anti-IL5 antibody

3、*Asthma*latozinemab(GSK4527223)Anti-sortilin antibody*Frontotemporal dementia1linerixibat(GSK2330672)IBAT inhibitorCholestatic pruritus in primary biliary cholangitisLow carbon version of MDI2,Ventolin(salbutamol)Beta 2 adrenergic receptor agonistAsthmaNucala(mepolizumab)Anti-IL5 antibodyCOPD3belres

4、totug(GSK4428859)Anti-TIGIT antibody*Non-small cell lung cancer*Blenrep(belantamab mafodotin)Anti-BCMA ADC*Multiple myelomacobolimab(GSK4069889)Anti-TIM-3 antibody*Non-small cell lung cancerJemperli(dostarlimab)Anti-PD-1 antibody*dMMR/MSI-H colon cancer*Zejula(niraparib)PARP inhibitor*Ovarian cancer

5、*Arexvy(RSV vaccine)Recombinant protein,adjuvanted*RSV adults(18-49 YoA4 AIR5)*bepirovirsen(GSK3228836)Antisense oligonucleotide*Chronic HBV6 infection*Bexsero(MenB vaccine)Recombinant protein,OMVMeningitis B(infants US)Blujepa(gepotidacin)BTI inhibitor*Uncomplicated UTI7*GSK4178116Live,attenuatedVa

6、ricella new strainibrexafungerp(GSK5458448)Antifungal glucan synthase inhibitor*Invasive candidiasistebipenem pivoxil(GSK3778712)Antibacterial carbapenem*Complicated UTI74*In-license or other alliance relationship with third party *Additional indications or candidates also under investigation In reg

7、istration1.Phase III trial in patients with progranulin gene mutation 2.Metered dose inhaler 3.Chronic obstructive pulmonary disorder 4.Years of age 5.At increased risk 6.Hepatitis B virus 7.Urinary tract infection 70 potential new vaccines and medicines in pipeline70 potential new vaccines and medi

8、cines in pipelineHIVHIVOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossaryInnovation:Pipeline growthRIIRI&IRI&IOncologyHIVInfectious DiseasesPhase IIPhase II26Benlysta(belimumab)Anti-BLys antibodySystemic sclerosis associated ILD1,2*GSK3915393TG2 inhibitor*Pulmonary fibrosisGSK452

9、7226(AL-101)Anti-sortilin antibody*Alzheimers diseaseGSK4532990HSD17B13 RNA interference*NASH/MASH3*GSK5784283TSLP monoclonal antibody*AsthmaGSK4381562Anti-PVRIG antibody*Cancernelistotug(GSK6097608)Anti-CD96 antibody*CancerOjjaara/Omjjara(momelotinib)JAK1,JAK2 and ACVR1 inhibitor*Myelodysplastic sy

10、ndrome*cabotegravir(GSK1265744)Integrase inhibitorHIVVH3810109Broadly neutralizing antibody*HIVVH4011499Capsid protein inhibitorHIVVH4524184Integrase inhibitor*HIValpibectir(BVL-GSK3729098)Ethionamide booster*Tuberculosisganfeborole(GSK3036656)Leucyl t-RNA synthetase inhibitor*TuberculosisGSK3437949

11、Recombinant protein,adjuvanted*Malaria fractional doseGSK3536852GMMA*ShigellaGSK3993129Recombinant subunit,adjuvantedCytomegalovirus4GSK4023393Recombinant protein,OMV,conjugated vaccineMenABCWY,2nd Gen4GSK4077164Bivalent GMMA*Invasive non-typhoidal salmonella*GSK4382276mRNA*Seasonal fluGSK4396687mRN

12、A*COVID-19GSK4406371Live,attenuatedMMRV5 new strainGSK5101955MAPS Pneumococcal 24-valent paed*Paediatric pneumococcal diseaseGSK5536522mRNA*Flu H5N1 pre-pandemic4GSK5637608Hepatitis B virus-targeted siRNA*Chronic HBV6 infectionsanfetrinem cilexetil(GV118819)Serine beta lactamase inhibitor*Tuberculos

13、is5*In-license or other alliance relationship with third party *Additional indications or candidates also under investigation1.Interstitial lung disease 2.In phase II/III study 3.Non-alcoholic steatohepatitis/metabolic dysfunction-associated steatohepatitis 4.In phase I/II study 5.Measles,Mumps,Rube

14、lla,and Varicella 6.Hepatitis B virus70 potential new vaccines and medicines in pipeline70 potential new vaccines and medicines in pipelineHIVHIVOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossaryInnovation:Pipeline growthRIIRI&IRI&IOncologyHIVInfectious DiseasesPhase IPhase I26GS

15、K3862995Anti-IL33 antibodyCOPD1GSK3888130Anti-IL7 antibody*Autoimmune diseaseGSK4172239DNMT1 inhibitor*Sickle cell diseaseGSK4347859Interferon pathway modulatorSystemic lupus erythematosusGSK4527363B-cell modulatorSystemic lupus erythematosusGSK4528287Anti-IL23-IL18 bispecific antibodyInflammatory b

16、owel diseaseGSK4771261Monoclonal antibody against novel kidney targetAutosomal dominant PKD2GSK5462688RNA-editing oligonucleotide*Alpha-1 antitrypsin deficiencyGSK5926371Anti-CD19-CD20-CD3 trispecific antibody*Autoimmune diseasebelantamab(GSK2857914)Anti-BCMA antibodyMultiple myeloma*GSK4418959Werne

17、r helicase inhibitor*dMMR/MSI-H solid tumours3GSK4524101DNA polymerase theta inhibitor*Cancer3GSK5733584ADC targeting B7-H4*Gynaecologic malignancies*GSK5764227ADC targeting B7-H3*Solid tumoursXMT-20564(wholly owned by Mersana Therapeutics)STING agonist ADC*CancerGSK6042981(IDRX-42)KIT inhibitor*Gas

18、trointestinal stromal tumoursVH4527079HIV entry inhibitorHIVGSK3536867Bivalent conjugate*Salmonella(typhoid+paratyphoid A)GSK3772701P.falciparum whole cell inhibitor*MalariaGSK3882347FimH antagonist*Uncomplicated UTI5GSK3923868PI4K beta inhibitorRhinovirus diseaseGSK3965193PAPD5/PAPD7 inhibitorChron

19、ic HBV6 infection3GSK4024484P.falciparum whole cell inhibitor*MalariaGSK5251738TLR8 agonist*Chronic HBV6 infectionGSK5102188Recombinant subunit,adjuvantedUTI3,5GSK5475152mRNA*Seasonal flu/COVID-1936*In-license or other alliance relationship with third party *Additional indications or candidates also

20、 under investigation1.Chronic obstructive pulmonary disorder 2.Polycystic kidney disease 3.In phase I/II study 4.GSK has an exclusive global license option to co-develop and commercialise the candidate 5.Urinary tract infection 6.Hepatitis B virus 70 potential new vaccines and medicines in pipeline7

21、0 potential new vaccines and medicines in pipelineHIVHIVOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossaryInnovation:Pipeline growthRIIRI&IRI&IOncologyHIVInfectious DiseasesPhase III/RegistrationPhase III/Registration6)camlipixant(GSK5464714)P2X3 receptor antagonistRefractory chr

22、onic coughdepemokimab(GSK3511294)Long-acting anti-IL5 antibody*Asthma*latozinemab(GSK4527223)Anti-sortilin antibody*Frontotemporal dementia1linerixibat(GSK2330672)IBAT inhibitorCholestatic pruritus in primary biliary cholangitisLow carbon version of MDI2,Ventolin(salbutamol)Beta 2 adrenergic recepto

23、r agonistAsthmaNucala(mepolizumab)Anti-IL5 antibodyCOPD3Phase IPhase I9GSK3862995Anti-IL33 antibodyCOPD3GSK3888130Anti-IL7 antibody*Autoimmune diseaseGSK4172239DNMT1 inhibitor*Sickle cell diseaseGSK4347859Interferon pathway modulatorSystemic lupus erythematosusGSK4527363B-cell modulatorSystemic lupu

24、s erythematosusGSK4528287Anti-IL23-IL18 bispecific antibodyInflammatory bowel diseaseGSK4771261Monoclonal antibody against novel kidney targetAutosomal dominant PKD7GSK5462688RNA-editing oligonucleotide*Alpha-1 antitrypsin deficiencyGSK5926371Anti-CD19-CD20-CD3 trispecific antibody*Autoimmune diseas

25、e7*In-license or other alliance relationship with third party *Additional indications or candidates also under investigation In registration1.Phase III trial in patients with progranulin gene mutation .2.Metered dose inhaler 3.Chronic obstructive pulmonary disorder 4.Interstitial lung disease 5.In p

26、hase II/III study 6.Non-alcoholic steatohepatitis/metabolic dysfunction-associated steatohepatitis 7.Polycystic kidney diseaseRespiratory,Immunology and Inflammation pipelineRespiratory,Immunology and Inflammation pipelinePhase IIPhase II5Benlysta(belimumab)Anti-BLys antibodySystemic sclerosis assoc

27、iated ILD4,5*GSK3915393TG2 inhibitor*Pulmonary fibrosisGSK4527226(AL-101)Anti-sortilin antibody*Alzheimers diseaseGSK4532990HSD17B13 RNA interference*NASH/MASH6*GSK5784283TSLP monoclonal antibody*AsthmaHIVHIVOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossaryInnovation:Pipeline gr

28、owthRIIRI&IRI&IOncologyHIVInfectious DiseasesPhase III/RegistrationPhase III/Registration5)belrestotug(GSK4428859)Anti-TIGIT antibody*Non-small cell lung cancer*Blenrep(belantamab mafodotin)Anti-BCMA ADC*Multiple myelomacobolimab(GSK4069889)Anti-TIM-3 antibody*Non-small cell lung cancerJemperli(dost

29、arlimab)Anti-PD-1 antibody*dMMR/MSI-H colon cancer*Zejula(niraparib)PARP inhibitor*Ovarian cancer*Phase IPhase I7belantamab(GSK2857914)Anti-BCMA antibodyMultiple myeloma*GSK4418959Werner helicase inhibitor*dMMR/MSI-H solid tumour1GSK4524101DNA polymerase theta inhibitor*Cancer1GSK5733584ADC targetin

30、g B7-H4*Gynaecologic malignancies*GSK5764227ADC targeting B7-H3*Solid tumoursXMT-20562(wholly owned by Mersana Therapeutics)STING agonist ADC*CancerGSK6042981(IDRX-42)KIT inhibitor*Gastrointestinal stromal tumours8*In-license or other alliance relationship with third party *Additional indications or

31、 candidates also under investigation In registration1.In phase I/II study 2.GSK has an exclusive global license option to co-develop and commercialise the candidateOncology pipelineOncology pipelinePhase IIPhase II3GSK4381562Anti-PVRIG antibody*Cancernelistotug(GSK6097608)Anti-CD96 antibody*CancerOj

32、jaara/Omjjara(momelotinib)JAK1,JAK2 and ACVR1 inhibitor*Myelodysplastic syndrome*HIVHIVOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossaryInnovation:Pipeline growthRIIRI&IRI&IOncologyHIVInfectious DiseasesPhase IPhase I1VH4527079HIV entry inhibitorHIV9*In-license or other alliance

33、 relationship with third partyHIV HIV pipelinepipelinePhase IIPhase II4cabotegravir(GSK1265744)Integrase inhibitorHIVVH3810109Broadly neutralizing antibody*HIVVH4011499Capsid protein inhibitorHIVVH4524184Integrase inhibitor*HIVHIVHIVOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGloss

34、aryInnovation:Pipeline growthRIIRI&IRI&IOncologyHIVInfectious DiseasesPhase III/RegistrationPhase III/Registration7)Arexvy(RSV vaccine)Recombinant protein,adjuvanted*RSV adults(18-49 YoA1 AIR2)*bepirovirsen(GSK3228836)Antisense oligonucleotide*Chronic HBV3 infection*Bexsero(MenB vaccine)Recombinant

35、protein,OMVMeningitis B(infants US)Blujepa(gepotidacin)BTI inhibitor*Uncomplicated UTI4*GSK4178116Live,attenuatedVaricella new strainibrexafungerp(GSK5458448)Antifungal glucan synthase inhibitor*Invasive candidiasistebipenem pivoxil(GSK3778712)Antibacterial carbapenem*Complicated UTI4Phase IPhase I9

36、GSK3536867Bivalent conjugate*Salmonella(typhoid+paratyphoid A)GSK3772701P.falciparum whole cell inhibitor*MalariaGSK3882347FimH antagonist*Uncomplicated UTI4GSK3923868PI4K beta inhibitorRhinovirus diseaseGSK3965193PAPD5/PAPD7 inhibitorChronic HBV3 infection5GSK4024484P.falciparum whole cell inhibito

37、r*MalariaGSK5251738TLR8 agonist*Chronic HBV3 infectionGSK5102188Recombinant subunit,adjuvantedUTI4,5GSK5475152mRNA*Seasonal flu/COVID-19510*In-license or other alliance relationship with third party *Additional indications or candidates also under investigation 1.Years of age 2.At increased risk 3.H

38、epatitis B virus 4.Urinary tract infection 5.In phase II/III study 6.Measles,Mumps,Rubella,and VaricellaInfectious Diseases pipelineInfectious Diseases pipelinePhase IIPhase II14alpibectir(BVL-GSK3729098)Ethionamide booster*Tuberculosisganfeborole(GSK3036656)Leucyl t-RNA synthetase inhibitor*Tubercu

39、losisGSK3437949Recombinant protein,adjuvanted*Malaria fractional doseGSK3536852GMMA*ShigellaGSK3993129Recombinant subunit,adjuvantedCytomegalovirus5GSK4023393Recombinant protein,OMV,conjugated vaccineMenABCWY,2nd Gen5GSK4077164Bivalent GMMA*Invasive non-typhoidal salmonella*GSK4382276mRNA*Seasonal f

40、luGSK4396687mRNA*COVID-19GSK4406371Live,attenuatedMMRV6 new strainGSK5101955MAPS Pneumococcal 24-valent paed*Paediatric pneumococcal diseaseGSK5536522mRNA*Flu H5N1 pre-pandemic5GSK5637608Hepatitis B virus-targeted siRNA*Chronic HBV3 infectionsanfetrinem cilexetil(GV118819)Serine beta lactamase inhib

41、itor*TuberculosisHIVHIVOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossaryInnovation:Pipeline growthRIIRI&IRI&IOncologyHIVInfectious Diseases11Changes since Q4 2024Changes since Q4 2024Changes on pipelineChanges on pipelinePipeline events in the quarterPipeline events in the quart

42、erRegulatory decisionsRegulatory decisionsBlenrep:DREAMM-7/8,2L+MM2UKBlujepa:EAGLE-2/3,uUTI3USPenmenvy:MenABCWY 1st Gen vaccineUSRegulatory submission acceptancesRegulatory submission acceptancesdepemokimab:SWIFT-1/2,asthmaUSdepemokimab:ANCHOR-1/2,CRSwNP4USNucala:MATINEE,COPD5EU,CNLateLate-stage rea

43、doutsstage readoutsZejula6:ZEAL,1L maintenance non-small cell lung cancer Phase III data readoutOther newsOther newsArexvy:RSV in adults 50-59 YoA6 AIR7 ACIP recommendation Penmenvy:MenABCWY 1st Gen vaccine ACIP recommendation1.Myelodysplastic syndrome 2.Multiple myeloma 3.Urinary tract infection 4.

44、Chronic rhinosinusitis with nasal polyps 5.Chronic obstructive pulmonary disease 6.Tesaro asset 7.Years of age 8.At increased riskNew to Phase IINew to Phase IIOjjaara/Omjjara(momelotinib):JAK1,JAK2 and ACVR1 inhibitor,MDS1New to Phase INew to Phase IGSK6042981(IDRX-42):KIT inhibitor,Gastrointestina

45、l stromal tumoursRemoved from Phase III/RegistrationRemoved from Phase III/RegistrationPenmenvy:MenABCWY 1st Gen vaccineRemoved from Phase IIRemoved from Phase IIGSK1070806:Anti-IL18 antibody,Atopic dermatitisVH3739937:Maturation inhibitor,HIVHIVHIVOncologyOncologyInfectious DiseasesInfectious Disea

46、sesGlossaryGlossaryInnovation:Pipeline growthRIIRI&IRI&IOncologyHIVInfectious DiseasesH1 2025H1 2025H2 2025H2 202520262026Regulatory Regulatory decisiondecisionNucala:MATINEE,COPD1USdepemokimab:SWIFT-1/2,asthmaUSdepemokimab:SWIFT-1/2,asthmaEU.CN,JPBlenrep:DREAMM-7/8,2L+MM2JPdepemokimab:ANCHOR-1/2,CR

47、SwNP8USdepemokimab:ANCHOR-1/2,CRSwNP8EU.CN,JPShingrix:18+YoA3 AIR4CNlinerixibat:GLISTEN,cholestatic pruritus in PBC5USlinerixibat:GLISTEN,cholestatic pruritus in PBC5EU,CN,JPShingrix liquid formulationUSBlenrep:DREAMM-7/8,2L+MM2US,EUNucala:MATINEE,COPD1EU,CNBlujepa(gepotidacin):EAGLE-1,GC9USVentolin

48、(low carbon MDI10):asthmaEUBlenrep:DREAMM-7/8,2L+MM2CNcobolimab6:COSTAR,2L NSCLC7US,EUcabotegravir:Q4M PrEP17,HIV preventionUSArexvy:18-49 YoA3 AIR4 and 18+IC11US,EU,JPbepirovirsen:B-WELL-1/2,chronic HBV18 infectionUS,JPBexsero:Men B(infants US)UStebipenem pivoxil:PIVOT-PO,cUTI12USRegulatory Regulat

49、ory submission submission acceptanceacceptancelinerixibat:GLISTEN,cholestatic pruritus in PBC5US,EUlinerixibat:GLISTEN,cholestatic pruritus in PBC5CN,JPcamlipixant:CALM-1/2,RCC13US,EU,JPVentolin(low carbon MDI10):asthmaEUdepemokimab:OCEAN,EGPA19US,EU,CN,JPBlenrep:DREAMM-8,2L+MM2CNlatozinemab:INFRONT

50、-315,FTD-GRN16US,EUcobolimab6:COSTAR,2L NSCLC7US,EUcabotegravir:Q4M PrEP17,HIV preventionUSArexvy:18-49 YoA3 AIR4 and 18+IC11US,EU,JPArexvy:Older adults 60+YoA3(China)CNBlujepa(gepotidacin):EAGLE-1,GC9USbepirovirsen:B-WELL-1/2,chronic HBV18 infectionUS,EU,CN,JPtebipenem pivoxil:PIVOT-PO,cUTI12USBexs

51、ero:Men B(infants US)USLateLate-stage stage Phase III Phase III readoutsreadoutsdepemokimab:AGILE,asthmacamlipixant:CALM-1,RCC13,14camlipixant:CALM-2,RCC13cobolimab6:COSTAR,2L NSCLC7depemokimab:NIMBLE,asthmadepemokimab:OCEAN,EGPA19latozinemab:INFRONT-315,FTD-GRN16Jemperli6:AZUR-1,Rectal cancer20,21V

52、entolin(low carbon MDI10):asthmacabotegravir:Q4M PrEP17,HIV prevention21Arexvy:Older adults 60+YoA3(China)bepirovirsen:B-WELL-1/2,chronic HBV18 infectionBexsero:Men B(infants US)tebipenem pivoxil:PIVOT-PO,cUTI12121.Chronic obstructive pulmonary disorder 2.Multiple myeloma 3.Years of age 4 At increas

53、ed risk 5.Primary biliary cholangitis 6.Tesaro asset 7.Non-small cell lung cancer 8.Chronic rhinosinusitis with nasal polyps 9.Urogenital gonorrhoea 10.Metered dose inhaler 11.Immunocompromised 12.Complicated urinary tract infection 13.Refractory chronic cough 14.CALM-1 results will be disclosed tog

54、ether with CALM-2 15.INFRONT-3 study is sponsored by Alector Inc.16.Frontotemporal dementia with progranulin gene mutation 17.Pre-Exposure Prophylaxis 18.Hepatitis B virus 19.Eosinophilic granulomatosis with polyangiitis 20.Neoadjuvant locally advanced dMMR/MSI-H rectal cancer 21.Pivotal phase II st

55、udyUpcoming pipeline catalysts:2025 and 2026Upcoming pipeline catalysts:2025 and 2026HIVHIVOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossaryInnovation:Pipeline growthRIIRI&IRI&IOncologyHIVInfectious DiseasesQualified Infectious Disease Product Designation Qualified Infectious Di

56、sease Product Designation 3Blujepa(gepotidacin)BTI inhibitor*Urogenital gonorrhoeaibrexafungerp(GSK5458448)Antifungal glucan synthase inhibitor*Invasive candidiasistebipenem pivoxil(GSK3778712)Antibacterial carbapenem*Complicated UTI5Priority ReviewPriority Review2Blenrep(belantamab mafodotin)Anti-B

57、CMA ADC*Relapsed or refractory multiple myelomaCN,JP13 BREAKTHROUGH DESIGNATIONUS:Expedite development and review of drugs to treat serious conditions and may demonstrate substantial improvement over available therapy.Criteria includes preliminary clinical evidence that indicates substantial improve

58、ment on clinically significant endpoint over available therapies.China:Enhance support for development of medicines to treat serious,life-threatening disease and target an unmet medical needEU(PRIME):Enhance support for development of medicines that target an unmet medical need or a product expected

59、 to bring major therapeutic advantage.FAST TRACK(US)Facilitate development and expedite review of drugs to treat serious conditions,including criteria that nonclinical or clinical data demonstrate potential to address unmet medical need OPHAN DRUG DESIGNATION intended for treatment,diagnosis or prev

60、ention of rare diseases(US,EU,Japan)PRIORITY REVIEWUS:A process that directs resources to the evaluation of drugs that represent significant improvements in safety or effectiveness compared with standard applications,with a shorter User-Fee review time compared to standard review(6 months vs.9 month

61、s)China:Process to expedite products of major interest in terms of public health and therapeutic innovation Japan:Faster access to new therapies responding to high medical needs,including orphan drugs and HIV medicines Qualified Infectious Disease Product Designation(US)an antibacterial or antifunga

62、l drug for human use intended to treat serious or life-threatening infections SENKU(Japan)Increase early patient access to innovative medicines through an expedited review process to treat serious conditions and fill an unmet medical need*In-license or other alliance relationship with third party1.I

63、n patients with progranulin gene mutation 2.Tesaro asset 3.Small-cell lung cancer 4.Hepatitis B virus 5.Urinary tract infection 6.Interstitial lung diseaseDesignations in our pipelineDesignations in our pipelineSENKUSENKU1bepirovirsen(GSK3228836)Antisense oligonucleotide*Chronic HBV4 infectionFast T

64、rackFast Track10latozinemab(GSK4527223)Anti-sortilin antibody*Frontotemporal dementia1GSK4172239DNMT1 inhibitor*Sickle cell diseaseGSK6042981(IDRX-42)KIT inhibitor*Gastrointestinal stromal tumoursJemperli 2(dostarlimab)Anti-PD-1 antibody*Neoadjuvant dMMR/MSI-H 1L rectal canceralpibectir(BVL-GSK37290

65、98)Ethionamide booster*Tuberculosisbepirovirsen(GSK3228836)Antisense oligonucleotide*Chronic HBV4 infectionBlujepa(gepotidacin)BTI inhibitor*Urogenital gonorrhoeaibrexafungerp(GSK5458448)Antifungal glucan synthase inhibitor*Invasive candidiasistebipenem pivoxil(GSK3778712)Antibacterial carbapenem*Co

66、mplicated UTI5GSK4382276mRNA*Seasonal fluBreakthrough DesignationBreakthrough Designation8latozinemab(GSK4527223)Anti-sortilin antibody*Frontotemporal dementia1USBlenrep(belantamab mafodotin)Anti-BCMA ADC*Relapsed or refractory multiple myelomaCNJemperli 2(dostarlimab)Anti-PD-1 antibody*Locally adva

67、nced dMMR/MSI-H rectal cancerUSGSK5764227ADC targeting B7-H3*Relapsed or refractory extensive-stage SCLC3US,EUGSK5764227ADC targeting B7-H3*Relapsed or refractory osteosarcomaUSbepirovirsen(GSK3228836)Antisense oligonucleotide*Chronic HBV4 infectionCNGSK5637608Hepatitis B virus-targeted siRNA*Chroni

68、c HBV4 infectionCNOrphan Drug DesignationOrphan Drug Designation11Benlysta(belimumab)Anti-BLys antibodySystemic sclerosis associated ILD6USdepemokimab(GSK3511294)Long-acting anti-IL5 antibody*Hypereosinophilic syndromeJPlatozinemab(GSK4527223)Anti-sortilin antibody*Frontotemporal dementia1US,EUliner

69、ixibat(GSK2330672)IBAT inhibitorCholestatic pruritus in primary biliary cholangitisUS,EUGSK6042981(IDRX-42)KIT inhibitor*Gastrointestinal stromal tumoursUS,EUBlenrep(belantamab mafodotin)Anti-BCMA ADC*Multiple myelomaJPibrexafungerp(GSK5458448)Antifungal glucan synthase inhibitor*Invasive candidiasi

70、sUS,EUInfectious diseaseInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossary14Clinical TrialsRI&IInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVOncologyOncologyInfectious DiseasesInfectious DiseasesGlossary

71、Glossary15Respiratory,Immunology and InflammationRI&IInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossary16Respiratory,Immunology and InflammationcamlipixantNCT05599191-CALM-1PhaseIIIPatientAdult participants with refractory

72、 chronic cough,including unexplained chronic coughSubjects825Treatment armsArm A:camlipixant 25 mg twice a dayArm B:camlipixant 50 mg twice a dayPlacebo twice a dayDescriptionA 52-week,randomised,double-blind,placebo-controlled,parallel-arm efficacy and safety study with open-label extension of caml

73、ipixant in adult participants with refractory chronic cough,including unexplained chronic coughTimelineTrial start:Q4 2022Key end points24-hour cough frequencyClinicaltrials.govLinkNCT05600777-CALM-2PhaseIIIPatientAdult participants with refractory chronic cough,including unexplained chronic coughSu

74、bjects825Treatment armsArm A:camlipixant 25 mg twice a dayArm B:camlipixant 50 mg twice a dayPlacebo twice a dayDescriptionA 24-week,randomised,double-blind,placebo-controlled,parallel-arm efficacy and safety study with open-label extension of camlipixant in adult participants with refractory chroni

75、c cough,including unexplained chronic coughTimelineTrial start:Q1 2023Key end points24-hour cough frequencyClinicaltrials.govLinkRI&IInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossary17Respiratory,Immunology and Inflammati

76、ondepemokimabNCT04719832-SWIFT-1PhaseIIIPatientAdult and adolescents with severe uncontrolled asthma with an eosinophilic phenotypeSubjects395Treatment armsArm A:depemokimab plus SoC Arm B:placebo plus SoC DescriptionA 52-week,randomised,double-blind,placebo-controlled,parallel-group,multi-centre tr

77、ial of the efficacy and safety of depemokimab adjunctive therapy in adult and adolescent participants with severe uncontrolled asthma with an eosinophilic phenotype TimelineTrial start:Q1 2021Data reported:Q2 2024Key end pointsAnnualised rate of clinically significant exacerbations over 52 weeksClin

78、icaltrials.govLinkNCT04718103-SWIFT-2PhaseIIIPatientAdult and adolescents with severe uncontrolled asthma with an eosinophilic phenotypeSubjects397Treatment armsArm A:depemokimab plus SoC Arm B:placebo plus SoC DescriptionA 52-week,randomised,double-blind,placebo-controlled,parallel-group,multi-cent

79、re trial of the efficacy and safety of depemokimab adjunctive therapy in adult and adolescent participants with severe uncontrolled asthma with an eosinophilic phenotypeTimelineTrial start:Q1 2021Data reported:Q2 2024Key end pointsAnnualised rate of clinically significant exacerbations over 52 weeks

80、Clinicaltrials.govLinkRI&IInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossary18Respiratory,Immunology and InflammationdepemokimabNCT05243680-AGILEPhaseIIIPatientAdult and adolescents with severe asthma with an eosinophilic

81、phenotype from studies SWIFT-1 and SWIFT-2Subjects641Treatment armsParticipants diagnosed with asthma receiving depemokimabDescriptionA 52-week,open label extension phase of SWIFT-1 and SWIFT-2 to assess the long-term safety and efficacy of depemokimab adjunctive therapy in adult and adolescent part

82、icipants with severe uncontrolled asthma with an eosinophilic phenotypeTimelineTrial start:Q1 2022Key end pointsNumber of participants with AEs and SAEs and incidence of immunogenicity over 52 weeksClinicaltrials.govLinkNCT04718389-NIMBLEPhaseIIIPatientAdult and adolescent severe asthmatic participa

83、nts with an eosinophilic phenotype treated with depemokimab compared with mepolizumab or benralizumabSubjects1667Treatment armsArm A:participants receiving depemokimab plus placebo matching prior anti-IL-5/5R treatmentArm B:participants receiving prior anti-IL-5/5R treatment plus placebo matching de

84、pemokimabDescriptionA 52-week,randomised,double-blind,double-dummy,parallel group,multi-centre,non-inferiority trial assessing exacerbation rate,additional measures of asthma control and safety in adult and adolescent severe asthmatic participants with an eosinophilic phenotype treated with depemoki

85、mab compared with mepolizumab or benralizumabTimelineTrial start:Q1 2021Key end pointsAnnualised rate of clinically significant exacerbations over 52 weeksClinicaltrials.govLinkRI&IInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVOncologyOncologyInfectious DiseasesInfectious DiseasesGlossar

86、yGlossary19Respiratory,Immunology and InflammationdepemokimabNCT05274750-ANCHOR-1PhaseIIIPatientAdults with chronic rhinosinusitis with nasal polyps(CRSwNP)Subjects276Treatment armsArm A:depemokimab plus SoCArm B:placebo plus SoCDescriptionA randomized,double-blind,parallel group trial to assess the

87、 efficacy and safety of 100 mg subcutaneous depemokimab in patients with CRSwNPTimelineTrial start:Q2 2022Data reported:Q3 2024Key end pointsChange from baseline in total endoscopic nasal polyps(NP)score at week 52Change from baseline in mean nasal obstruction verbal response scale(VRS)score from We

88、ek 49 through to Week 52Clinicaltrials.govLinkNCT05281523-ANCHOR-2PhaseIIIPatientAdults with chronic rhinosinusitis with nasal polyps(CRSwNP)Subjects264Treatment armsArm A:depemokimab plus SoCArm B:placebo plus SoCDescriptionA randomized,double-blind,parallel group trial to assess the efficacy and s

89、afety of 100 mg subcutaneous depemokimab in patients with CRSwNPTimelineTrial start:Q2 2022Data reported:Q3 2024Key end pointsChange from baseline in total endoscopic nasal polyps(NP)score at week 52Change from baseline in mean nasal obstruction verbal response scale(VRS)score from Week 49 through t

90、o Week 52Clinicaltrials.govLinkRI&IInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossary20Respiratory,Immunology and InflammationdepemokimabNCT05263934-OCEANPhaseIIIPatientAdults with relapsing or refractory eosinophilic gran

91、ulomatosis with polyangiitis(EGPA)receiving standard of care therapySubjects160Treatment armsArm A:depemokimab+placebo matching mepolizumab+SoCArm B:mepolizumab+placebo matching depemokimab+SoCDescriptionA 52-week randomised,double-blind,double-dummy,parallel-group,multicentre,non-inferiority trial

92、to investigate the efficacy and safety of depemokimab compared with mepolizumab in adults with relapsing or refractory EGPA receiving standard of care therapyTimelineTrial start:Q3 2022Key end pointsNumber of participants with remissionClinicaltrials.govLinkNCT05334368-DESTINYPhaseIIIPatientAdults w

93、ith hypereosinophilic syndrome(HES)receiving standard of care therapySubjects120Treatment armsArm A:depemokimab+SoCArm B:placebo+SoCDescriptionA randomised,double-blind,placebo-controlled trial to investigate the efficacy and safety of depemokimab in adults with HESTimelineTrial start:Q3 2022Key end

94、 pointsFrequency of HES flaresClinicaltrials.govLinkRI&IInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossary21Respiratory,Immunology and InflammationlinerixibatNCT04950127-GLISTENPhaseIIIPatientParticipants with primary bili

95、ary cholangitis(PBC)Subjects238Treatment armsArm A:linerixibatArm B:linerixibat followed by placeboArm C:placeboArm D:placebo followed by linerixibatDescriptionA two-part randomised,placebo controlled,double blind,multicentre trial to evaluate the efficacy and safety of linerixibat for the treatment

96、 of cholestatic pruritus in participants with primary biliary cholangitis TimelineTrial start:Q3 2021Data reported:Q4 2024Key end pointsChange from baseline in monthly itch scores over 24 weeks using Numerical Rating Scale(NRS)Clinicaltrials.govLinkRI&IInnovation:Pipeline growthInnovation:Pipeline g

97、rowthHIVHIVOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossary22Respiratory,Immunology and InflammationVentolin(low carbon version of MDI)NCT06261957PhaseIIIPatientParticipants aged 12 years and above with asthmaSubjects412Treatment armsArm A:Salbutamol HFA-134aArm B:Salbutamol HF

98、A-152aDescriptionA randomized,double-blind,parallel group,multi-centre study to evaluate the long-term safety of salbutamol rescue medication when administered via metered dose inhalers containing the propellant HFA-152a or reference HFA-134aTimelineTrial start:Q2 2024Key end pointsAEsClinicaltrials

99、.govLinkRI&IInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossary23Respiratory,Immunology and InflammationNucala(mepolizumab)NCT04133909-MATINEEPhaseIIIPatientParticipants with chronic obstructive pulmonary disease(COPD)exper

100、iencing frequent exacerbations and characterised by eosinophil levelsSubjects806Treatment armsArm A:placeboArm B:mepolizumabDescriptionA multicentre randomised,double-blind,parallel-group,placebo-controlled trial of mepolizumab 100 mg subcutaneously as add-on treatment in participants with COPD expe

101、riencing frequent exacerbations and characterised by eosinophil levelsTimelineTrial start:Q4 2019Primary data reported:Q3 2024Key end pointsAnnualised rate of moderate or severe exacerbationsClinicaltrials.govLinkRI&IInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVOncologyOncologyInfectiou

102、s DiseasesInfectious DiseasesGlossaryGlossary24Respiratory,Immunology and InflammationBenlysta(belimumab)NCT05878717-BLISSc-ILDPhaseII/IIIPatientAdults with systemic sclerosis associated interstitial lung disease(SSc-ILD)Subjects300Treatment armsArm A:belimumab+standard therapyArm B:placebo+standard

103、 therapyDescriptionA randomized,double-blind,placebo-controlled,parallel-group trial to evaluate the efficacy and safety of belimumab administered subcutaneously in adults with SSc-ILDTimelineTrial start:Q3 2023Key end pointsAbsolute change from baseline in Forced Vital Capacity(FVC)millilitre(mL)at

104、 week 52Clinicaltrials.govLinkNCT06572384-BEconneCTD-ILDPhaseIIIPatientAdults with Interstitial Lung Disease(ILD)associated with Connective Tissue Disease(CTD)Subjects440Treatment armsArm A:belimumab+standard therapyArm B:placebo+standard therapyDescriptionA randomized,double-blind,placebo controlle

105、d,parallel group study to evaluate the efficacy and safety of belimumab administered subcutaneously in adults with Interstitial Lung Disease(ILD)associated with Connective Tissue Disease(CTD)TimelineTrial start:Q3 2024Key end pointsAbsolute change from baseline in Forced Vital Capacity(FVC)millilitr

106、e(mL)at week 52Clinicaltrials.govLinkRI&IInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossary25Respiratory,Immunology and InflammationGSK3915393(Pulmonary fibrosis)NCT06317285PhaseIIPatientParticipants with Idiopathic Pulmon

107、ary Fibrosis(IPF)Subjects150Treatment armsArm A:GSK3915393Arm B:placeboDescriptionA randomized,double-blind,placebo controlled,parallel group study(TRANSFORM)to evaluate the efficacy and safety of GSK3915393 in participants With Idiopathic Pulmonary Fibrosis(IPF)TimelineTrial start:Q2 2024Key end po

108、intsAbsolute change from baseline in Forced Vital Capacity(FVC)in millilitres(mL)at Week 26Clinicaltrials.govLinkRI&IInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossary26Respiratory,Immunology and InflammationGSK4527226(Alz

109、heimers disease)NCT06079190-PROGRESS-ADPhaseIIPatientParticipant must be in the Alzheimers continuum as defined by the 2018 National Institute on Aging and Alzheimers Association(NIAAA)Research Framework corresponding to the clinical categories of MCI due to AD and mild AD dementia.Subjects282Treatm

110、ent armsArm 1:GSK4527226 Dose 1Arm 2 GSK4527226 Dose 2Arm 3:PlaceboDescriptionA parallel group,randomized,double-blind,placebo-controlled,3-arm,multicentre treatment study to evaluate the efficacy and safety of GSK4527226(AL101)intravenous infusion compared with placebo in patients with early Alzhei

111、mers DiseaseTimelineTrial start:Q4 2023Key end pointsCDR-SB,iADRS,ADAS-Cog14,ADCS-ADL-MCI,ADCS-iADL,ADCOMS Clinicaltrials.govLinkRI&IInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossary27Respiratory,Immunology and Inflammati

112、onGSK4532990(NASH/MASH)NCT05583344-HORIZONPhaseIIbPatientAdults with non-alcoholic steatohepatitis(NASH)and advanced fibrosisSubjects284Treatment armsArm 1:high dose GSK4532990Arm 2:low dose GSK4532990Arm 3:placeboDescriptionA placebo-controlled trial to evaluate the efficacy and safety of GSK453299

113、0 in adults with advanced non-alcoholic steatohepatitis(NASH)TimelineTrial start:Q1 2023Key end pointsPart 1:Percentage of participants achieving 1 stage improvement in histological fibrosis with no worsening of NASH(at week 52)Part 2:Percentage of participants achieving NASH resolution with no wors

114、ening of fibrosis(at week 52)Clinicaltrials.govLinkNCT06104319-SKYLINEPhaseIIaPatientAdult participants with NASH or suspected NASHSubjects56Treatment armsArm 1:GSK4532990 Dose 1Arm 2:GSK4532990 Dose 2Arm 3:GSK4532990 Dose 3Arm 4:GSK4532990 Dose 4DescriptionA single dose,open-label,dose exploration

115、study to assess the PK-PD activity,safety,and tolerability of GSK4532990 in adult participants with NASH or suspected NASHTimelineTrial start:Q1 2024Key end pointsPredicted percent change from baseline in liver biopsy-derived HSD17B13 protein expression levels and mRNA expression levelsClinicaltrial

116、s.govLinkRI&IInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossary28Respiratory,Immunology and InflammationGSK4532990(ALD)NCT06613698-STARLIGHTPhaseIIPatientAdults with alcohol-related liver disease(ALD)Subjects393Treatment a

117、rmsArm 1:GSK4532990 Dose 1Arm 2:GSK4532990 Dose 2Arm 3:GSK4532990 Dose 3Arm 4:GSK4532990 Dose 4Arm 5:PlaceboDescriptionA dose-finding,double-blind,placebo-controlled study to evaluate the efficacy and safety of GSK4532990 for steatohepatitis in adults with ALDTimelineTrial start:Q4 2024Key end point

118、sAEs,SAEsChange from baseline in Liver Stiffness measurement(LSM)reduction using FibroScan at Week 28(kiloPascal)Liver stiffness will be measured by vibration-controlled transient elastography(VCTE)using the FibroScan device.Change from baseline in model for end-stage liver disease(MELD)score reduct

119、ion at Week 28Clinicaltrials.govLinkRI&IInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossary29Respiratory,Immunology and InflammationGSK5784283(Asthma)NCT06748053PhaseIIPatientAdults aged 18 to 75 years of age with uncontrol

120、led asthmaSubjects300Treatment armsPart A:Dose finding:GSK5784283 or placeboPart B:Extended dosing:GSK5784283 or placeboDescriptionA multicentre,randomized,double-blind,placebo controlled,dose finding phase 2 study of anti-TSLP antibody(GSK5784283)in adults aged 18 to 75 years of age with uncontroll

121、ed asthma.TimelineTrial start:Q1 2025Key end pointsChange from baseline in the fraction of exhaled nitric oxide(FeNo)Clinicaltrials.govLinkRI&IInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossary30Respiratory,Immunology and

122、InflammationGSK3862995(COPD)NCT06154837PhaseIPatientPart A:Healthy participantsPart B:Participants with Chronic Obstructive Pulmonary DisorderSubjects120Treatment armsPart A:Single ascending dose(SAD)of GSK3862995BPart B,arm A:Repeat doses GSK3862995BPart B,arm B:PlaceboDescriptionA two-part randomi

123、zed,double-blind,placebo-controlled study to investigate safety,tolerability,immunogenicity,pharmacokinetics and pharmacodynamics of GSK3862995B following single ascending doses in healthy participants and repeat doses in participants with Chronic Obstructive Pulmonary Disease(COPD)TimelineTrial sta

124、rt:Q4 2023Key end pointsAEs and SAEs Clinicaltrials.govLinkRI&IInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossary31Respiratory,Immunology and InflammationGSK4172239(Sickle cell disease)NCT05660265PhaseIPatientParticipants

125、with sickle cell diseaseSubjects40Treatment armsCohort 1:GSK4172239D(Dose 1)or placeboCohort 2:GSK4172239D(Dose 2)or placeboCohort 3:GSK4172239D(Dose 3)or placeboCohort 4:GSK4172239D(Dose 4)or placeboCohort 5:GSK4172239D(Dose 5)or placeboFood effect cohortDescriptionA randomised,placebo-controlled,d

126、ouble-blind(sponsor unblind),parallel group,single dose,dose escalation to evaluate the safety,tolerability and pharmacokinetics of GSK4172239DTimelineTrial start:Q3 2023Key end pointsArea under curve zero to time infinity(AUC 0-inf)for GSK4106401 after a single oral dose of GSK4172239DClinicaltrial

127、s.govLinkRI&IInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossary32Respiratory,Immunology and InflammationGSK4347859(Systemic lupus erythematosus)NCT06188507PhaseIPatientHealthy participantsSubjects49Treatment armsPart 1,coh

128、ort 1:GSK4347859 or placeboPart 1,cohort 2:GSK4347859 or placeboPart 2,cohort 3:GSK4347859(dose level A)or placeboPart 2,cohort 4:GSK4347859(dose level B)or placeboPart 2,cohort 5:GSK4347859(dose level C)or placeboDescriptionA randomized,double-blind,placebo-controlled study to evaluate the safety,t

129、olerability,pharmacokinetics and pharmacodynamics of GSK3996401 following single and multiple ascending doses of GSK4347859 in healthy participantsTimelineTrial start:Q1 2024Key end pointsAEs and SAEsMaximum observed plasma concentration(Cmax)of GSK3996401 following administration of GSK4347859Clini

130、caltrials.govLinkRI&IInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossary33Respiratory,Immunology and InflammationGSK4527363(Systemic lupus erythematosus)NCT06576271PhaseIPatientPart A:healthy participantsPart B:participants

131、 with active systemic lupus erythematosusPart C:healthy participants of Chinese and Japanese descentSubjects112Treatment armsPart A:Healthy participants receiving GSK4527363,placebo matching GSK4527363,or belimumabPart B:Participants with SLE receiving GSK4527363 or belimumabPart C:Healthy Japanese

132、and Chinese participants receiving GSK4527363 or placebo matching GSK4527363DescriptionA first-time-in-human,three-part study to evaluate the safety,tolerability,pharmacokinetics,pharmacodynamics,and immunogenicity of GSK4527363TimelineTrial start Q3 2024Key end pointsAEs and SAEsClinically signific

133、ant changes in physical examination,laboratory parameters,vital signs,and 12 lead electrocardiogram(ECG)findings Number of participants with clinically significant changes in Columbia-Suicide Severity Rating Scale(C-SSRS)Clinicaltrials.govLinkRI&IInnovation:Pipeline growthInnovation:Pipeline growthH

134、IVHIVOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossary34Respiratory,Immunology and InflammationGSK4528287(IBD)NCT06681181PhaseIPatientHealthy participantsSubjects48Treatment armsPart A:Dose 1 of GSK4528287Part B:Dose 2 of GSK4528287Part C:Dose 3 of GSK4528287Part D:Dose 4 of GSK

135、4528287Part E:Dose 5 of GSK4528287Part F:Dose 6 of GSK4528287Part G:Placebo comparatorDescriptionA randomized,double blind,placebo controlled,single dose escalation study to evaluate the safety,tolerability,pharmacokinetics,and target engagement of GSK4528287 in healthy participantsTimelineTrial sta

136、rt:Q4 2024Key end pointsAEs and SAEs Clinicaltrials.govLinkRI&IInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossaryNCT06734234PhaseIPatientPart A:Healthy participantsPart B:Participants with autosomal dominant polycystic kid

137、ney disease(ADPKD)Subjects84Treatment armsPart A:Health participants receiving different doses of GSK4771261,or placeboPart B:Participants with ADPKD receiving different doses of GSK4771261,or placeboDescriptionA two-part randomized,double-blind,placebo-controlled,multi-centre study to evaluate safe

138、ty,tolerability,and effects on blood and urine markers of single ascending doses of GSK4771261TimelineTrial start:Q4 2024Key end pointsAEs and SAEs Clinicaltrials.govLink35Respiratory,Immunology and InflammationGSK4771261(Autosomal dominant polycystic kidney disease)RI&IInnovation:Pipeline growthInn

139、ovation:Pipeline growthHIVHIVOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossary36Respiratory,Immunology and InflammationbelantamabNCT06413511PhaseIbPatientParticipants with autoimmune diseaseSubjects16Treatment armsbelantamabDescriptionA dose escalation,open label study to evalua

140、te the safety,tolerability,pharmacokinetics and pharmacological effect of a single intravenous infusion of belantamab in participants with autoimmune diseaseTimelineTrial start:Q2 2024Key end pointsAEs,SAEsClinicaltrials.govLinkOncologyInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&

141、IInfectious DiseasesInfectious DiseasesGlossaryGlossary37OncologyOncologyInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IInfectious DiseasesInfectious DiseasesGlossaryGlossary38Oncologybelrestotug&CD226 assetsNCT05565378-GALAXIES LUNG-201PhaseIIPatientParticipants with previously un

142、treated,locally advanced/metastatic,Programmed Death Ligand 1-selected non small cell lung cancer(NSCLC)Subjects340Treatment armsComparator Arm:pembrolizumab monotherapyIntervention Arm:dostarlimab monotherapySubstudy 1A:dostarlimab+belrestotug(Dose A)Substudy 1B:dostarlimab+belrestotug(Dose B)Subst

143、udy 1C:dostarlimab+belrestotug(Dose C)Substudy 2:dostarlimab+belrestotug+nelistotugDescriptionA randomized,open-label,platform trial utilizing a master protocol to evaluate novel immunotherapy combinations in participants with previously untreated,locally advanced/metastatic,Programmed Death Ligand

144、1-selected NSCLCTimelineTrial start:Q4 2022Key end pointsORRClinicaltrials.govLinkNCT06472076-GALAXIES LUNG-301PhaseIIIPatientParticipants with previously untreated,unresectable,locally advanced or metastatic PD-L1 selected non-small cell lung cancerSubjects1000TreatmentarmsExperimental:dostarlimab

145、plus belrestotugComparator:pembrolizumab plus placeboDescriptionA randomized,multicentre,double-blind trial to investigate the safety and efficacy of belrestotug in combination with dostarlimab compared with placebo in combination with pembrolizumab in participants with previously untreated,unresect

146、able,locally advanced or metastatic PD-L1 selected non-small cell lung cancerTimelineTrial start:Q3 2024Key end pointsPFS,OSClinicaltrials.govLinkOncologyInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IInfectious DiseasesInfectious DiseasesGlossaryGlossary39Oncologybelrestotug&CD226

147、 assetsNCT03739710 ENTRE LungPhaseIIPatientParticipants with non-small cell lung cancer(NSCLC)Subjects176Treatment armsArm B:dostarlimab+belrestotugArm C:dostarlimab+belrestotug+nelistotugDescriptionA randomized,open-label platform trial utilizing a master protocol to trial novel regimens versus sta

148、ndard of care treatment in NSCLC participantsTimelineTrial start:Q1 2019Key end pointsPart 1:Number of participants with AEs,SAEs,DLT,clinically significant changes in vital signs,physical examination and laboratory parameters.Number of participants requiring dose modifications.Part 2:Overall surviv

149、alClinicaltrials.govLinkNCT06062420-GALAXIES H&N-202PhaseIIPatientParticipants with recurrent/metastatic PD-L1 positive squamous cell carcinoma of the head and neckSubjects360Treatment armsdostarlimab monotherapySub study 1:dostarlimab and belrestotugSub study 2:dostarlimab and nelistotugSub study 3

150、:dostarlimab and belrestotug and nelistotugSub study 4:dostarlimab and GSK4381562DescriptionA randomized,open-label,platform study using a master protocol to evaluate novel immunotherapy combinations as first-line treatment in participants with recurrent/metastatic PD-L1 positive squamous cell carci

151、noma of the head and neckTimelineTrial start:Q4 2023Key end pointsORRClinicaltrials.govLinkOncologyInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IInfectious DiseasesInfectious DiseasesGlossaryGlossary40Oncologybelrestotug&CD226 assetsNCT04446351-nelistotug FTIHPhaseIPatientParticip

152、ants with advanced solid tumoursSubjects107Treatment armsArm A:nelistotugArm B:nelistotug+dostarlimabArm D dostarlimabArm E:dostarlimab+belrestotug Arm F:dostarlimab+belrestotug+nelistotugArm G:dostarlimab+cobolimabDescriptionA first time in human,open-label trial of nelistotug(GSK6097608)administer

153、ed as monotherapy and in combination with anticancer agentsTimelineTrial start:Q1 2020Key end pointsDLT,AEs and SAEsClinicaltrials.govLinkNCT05277051-PVRIG FTIHPhaseIPatientParticipants with selected advanced solid tumorsSubjects141Treatment armsArm A:GSK4381562 monotherapyArm B:GSK4381562 plus dost

154、arlimabArm C:GSK4381562 plus dostarlimab plus belrestotugArm D:dostarlimab plus belrestotugArm E:dostarlimab plus belrestotug plus GSK4381562Arm F:dostarlimab plus belrestotug plus nelistotugArm G:China Cohort:Participants receiving dostarlimabArm H:China Cohort:Participants receiving dostarlimab pl

155、us belrestotugArm I:GSK5764227 plus dostarlimabDescriptionAn open-label study of GSK4381562 administered as monotherapy and in combination with anticancer agentsTimelineTrial start:Q1 2022Key end pointsDLT,Safety and PKClinicaltrials.govLinkOncologyInnovation:Pipeline growthInnovation:Pipeline growt

156、hHIVHIVRIIRI&IInfectious DiseasesInfectious DiseasesGlossaryGlossary41OncologyBlenrep(belantamab mafodotin)NCT04246047-DREAMM-7PhaseIIIPatientParticipants with relapsed/refractory multiple myeloma(RRMM)Subjects494Treatment armsArm A:belantamab mafodotin+bortezomib+dexamethasone(B-Vd)Arm B:daratumuma

157、b,bortezomib+dexamethasone(D-Vd)DescriptionA multicentre,open-label,randomised trial to evaluate the efficacy and safety of the combination of belantamab mafodotin,bortezomib and dexamethasone(B-Vd)compared with the combination of daratumumab,bortezomib and dexamethasone(D-Vd)TimelineTrial start:Q2

158、2020Primary data reported:Q4 2023Key end pointsPFS,CRR,ORR,DoR,TTR,TTP,OS,PFS2,MRD negativity rate,safetyClinicaltrials.govLinkNCT04484623-DREAMM-8PhaseIIIPatientParticipants with relapsed/refractory multiple myeloma(RRMM)Subjects302Treatment armsArm A:belantamab mafodotin+pomalidomide+dexamethasone

159、(B-Pd)Arm B:Pomalidomide,bortezomib+dexamethasone(P-Vd)DescriptionA multicentre,open-label,randomised trial to evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone(B-Pd)versus pomalidomide plus bortezomib and dexamethasone(PVd)TimelineTrial star

160、t:Q4 2020Primary data reported:Q1 2024Key end pointsPFS,MRD negativity rate,ORR,CRR,VGPR or better rate,DoR,TTBR,TTR,TTP,OS,PFS2,safetyClinicaltrials.govLinkOncologyInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IInfectious DiseasesInfectious DiseasesGlossaryGlossary42OncologyBlenre

161、p(belantamab mafodotin)NCT04126200-DREAMM-5PhaseI/IIPatientParticipants with relapsed/refractory multiple myeloma(RRMM)Subjects209Treatment armsSubstudy 1:belantamab mafodotin+OX40(GSK3174998)Substudy 2:belantamab mafodotin+feladilimab Substudy 3:belantamab mafodotin+nirogacestat(GSI)Substudy 4:bela

162、ntamab mafodotin+dostarlimabSubstudy 5:belantamab mafodotin+isatuximab Substudy 6:belantamab mafodotin+nirogacestat+lenalidomide+dexamethasone Substudy 7:belantamab mafodotin+nirogacestat+pomalidomide+dexamethasoneDescriptionA randomised,open-label platform trial utilizing a master protocol to trial

163、 belantamab mafodotin as monotherapy and in combination with anti-cancer treatmentsTimelineTrial start:Q4 2019Key end pointsDose escalation phase:DLT,safety,ORRCohort expansion phase:ORR,CBR,safetyClinicaltrials.govLinkNCT04091126-DREAMM-9PhaseIPatientPatients with newly diagnosed multiple myeloma(M

164、M)Subjects118Treatment armsBelantamab mafodotin,selected dosesBortezomib,administered subcutaneously or intravenously approximately 1 hour after the belantamab mafodotin infusion until Cycle 8Lenalidomide,administered as 25 or 10 mg orally,depending upon renal function.Dexamethasone,administered ora

165、lly as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwardsDescriptionA randomised,dose and schedule evaluation trial to investigate the safety,pharmacokinetics,pharmacodynamics and clinical activity of belantamab mafodotin administered in combination with standard of careTimelineTrial start:Q4 2019Key

166、end pointsDLT,safety,RDI of lenalidomide and bortezomib,PK,PD,ORR,CRR,VGPR or betterClinicaltrials.govLinkOncologyInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IInfectious DiseasesInfectious DiseasesGlossaryGlossary43OncologyBlenrep(belantamab mafodotin)NCT06679101-DREAMM-10 PhaseI

167、IIPatientNewly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation(TI-NDMM)Subjects520Treatment armsArm A:belantamab mafodotin+lenalidomide+dexamethasoneArm B:daratumumab+lenalidomide+dexamethasoneDescriptionOpen label trial of belantamab mafodotin in combination w

168、ith lenalidomide and dexamethasone(BRd)to evaluate if this prolongs progression free survival and/or improves minimal residual disease negative status compared with daratumumab,lenalidomide,and dexamethasone(DRd)in participants with TI-NDMMTimelineTrial start:Q4 2024 Key end pointsPFS,MRD negativity

169、 rateClinicaltrials.govLinkNCT04398745-DREAMM-12PhaseIPatientRelapsed/refractory multiple myeloma(RRMM)who have normal and varying degrees of impaired renal function Subjects36Treatment armsbelantamab mafodotin monotherapy DescriptionA trial to evaluate the pharmacokinetics and safety of belantamab

170、mafodotin monotherapyTimelineTrial start:Q4 2020Key end pointsPK,change in vital signs,safetyClinicaltrials.govLinkOncologyInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IInfectious DiseasesInfectious DiseasesGlossaryGlossary44OncologyBlenrep(belantamab mafodotin)NCT04398680-DREAMM-

171、13PhaseIPatientRelapsed/refractory multiple myeloma(RRMM)who have normal and impaired hepatic functionSubjects28Treatment armsbelantamab mafodotin monotherapy DescriptionA trial to evaluate the pharmacokinetics and safety of belantamab mafodotin monotherapy in participants who have normal and impair

172、ed hepatic functionTimelineTrial start:Q2 2021Key end pointsPK,change in vital signs,safetyClinicaltrials.govLinkNCT05064358-DREAMM-14PhaseIIPatientParticipants with relapsed/refractory multiple myeloma(RRMM)Subjects177Treatment armsbelantamab mafodotinDescriptionA randomised,parallel,open-label stu

173、dy to investigate the safety,efficacy and pharmacokinetics of various dosing regimens of single-agent belantamab mafodotin(GSK2857916)TimelineStudy start:Q1 2022Key end points%of patients with=Gr 2 ocular events,safety,ORR,TTR,DoR,TTP,PFS,OSClinicaltrials.govLinkOncologyInnovation:Pipeline growthInn

174、ovation:Pipeline growthHIVHIVRIIRI&IInfectious DiseasesInfectious DiseasesGlossaryGlossary45OncologycobolimabNCT04655976-COSTAR LUNGPhaseII/IIIPatientPatients with advanced non-small cell lung cancer(NSCLC)who have progressed on prior anti-PD-(L)1 therapy and chemotherapySubjects758Treatment armsArm

175、 A:cobolimab+dostarlimab+docetaxelArm B:dostarlimab+docetaxelArm C:docetaxelDescriptionA randomised,open label trial comparing cobolimab+dostarlimab+docetaxel to dostarlimab+docetaxel to docetaxel aloneTimelineTrial start:Q4 2020Key end pointsOS(primary),ORR,PFS,DoR,TTDClinicaltrials.govLinkOncology

176、Innovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IInfectious DiseasesInfectious DiseasesGlossaryGlossary46OncologyJemperli(dostarlimab)NCT03981796-RUBY ENGOT-EN6 GOG-3031PhaseIIIPatientPatients with recurrent or primary advanced endometrial cancerSubjects785Treatment armsArm A:dostarl

177、imab+SoC followed by dostarlimabArm B:placebo+SoC followed by placeboArm C:dostarlimab+SoC followed by dostarlimab+niraparibArm D:placebo(+SoC)followed by placeboDescriptionA randomised,double-blind,multi-centre trial of dostarlimab plus carboplatin-paclitaxel with and without niraparib maintenance

178、versus placebo plus carboplatin-paclitaxel in patients with recurrent or primary advanced endometrial cancerTimelineTrial start:Q3 2019Part 1 data reported:Q4 2022;Part 2 data reported:Q4 2023Key end pointsPart 1:Co-primary PFS by IA(dMMR/MSI-H and ITT)and OS(ITT)Part 2:Primary PFS(ITT)and key secon

179、dary OS(ITT)Clinicaltrials.govLinkNCT04581824-PERLAPhaseIIPatientParticipants with metastatic non-squamous non-small cell lung cancer(NSCLC)Subjects243Treatment armsArm A:dostarlimab+chemotherapyArm B:pembrolizumab+chemotherapyDescriptionA randomised,double-blind trial to evaluate the efficacy of do

180、starlimab plus chemotherapy versus pembrolizumab plus chemotherapy in metastatic non-squamous NSCLCTimelineTrial start:Q4 2020Primary data reported:Q4 2022Key end pointsORR,OS,PFSClinicaltrials.govLinkOncologyInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IInfectious DiseasesInfecti

181、ous DiseasesGlossaryGlossary47OncologyJemperli(dostarlimab)NCT02715284-GARNETPhaseI/IIPatientParticipants with advanced solid tumoursSubjects740Treatment armsPart 1:dostarlimab at ascending weight dosesPart 2A:dostarlimab fixed dose of 500mg Q3W or 1000mg administered Q6W dosePart 2B:Cohort A1 dMMR/

182、MSI-H endometrialPart 2B:Cohort A2 MMR proficient/MSS endometrialPart 2B:Cohort E:NSCLCPart 2B:Cohort F non-endometrial dMMR/MSI-H&POLE-mutationPart 2B:Cohort G PROC without known BRCADescriptionA multi-centre,open-label,first-in-human trial evaluating dostarlimab in participants with advanced solid

183、 tumours who have limited available treatment optionsTimelineTrial start:Q1 2016Primary data reported:Q1 2019Key end pointsORR,DoR,safetyClinicaltrials.govLinkNCT05723562-AZUR-1PhaseIIPatientPatients with untreated stage II/III mismatch repair deficient/high microsatellite instability(dMMR/MSI-H)loc

184、ally advanced rectal cancerSubjects154Treatment armsdostarlimab monotherapyDescriptionA single-arm,open-label trial with dostarlimab monotherapy in participants with untreated stage II/III dMMR/MSI-H locally advanced rectal cancerTimelineTrial start:Q1 2023Key end pointsSustained cCR for 12,24 and 3

185、6 months,EFS at 3 yearsClinicaltrials.govLinkOncologyInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IInfectious DiseasesInfectious DiseasesGlossaryGlossary48OncologyJemperli(dostarlimab)NCT05855200-AZUR-2PhaseIIIPatientParticipants with untreated T4N0 or Stage III(resectable),mismat

186、ch repair deficient/high microsatellite instability(dMMR/MSI-H)colon cancerSubjects711Treatment armsArm A:dostarlimabArm B:Standard of care(FOLFOX/CAPEOX)or expectant observation post surgery.DescriptionAn open-label,randomized trial of perioperative dostarlimab monotherapy versus standard of care i

187、n participants with untreated T4N0 or Stage III dMMR/MSI-H resectable colon cancerTimelineTrial start:Q3 2023Key end pointsEFS assessed by Blinded Independent Central Review(BICR)Clinicaltrials.govLinkNCT06567782-AZUR-4PhaseIIPatientParticipants with previously untreated T4N0 or stage III MMRp/MSS c

188、olon cancerSubjects120Treatment armsArm A:dostarlimab plus CAPEOX(chemotherapy)Arm B:CAPEOX(chemotherapy)DescriptionAn open label,randomized study of neoadjuvant dostarlimab plus CAPEOX versus CAPEOX in participants with previously untreated T4N0 or stage III MMRp/MSS colon cancerTimelineTrial start

189、:Q4 2024Key end pointsMajor pathological response(mPR)rate,AEs,SAEs,immune-mediated AEs,and AEs leading to death or discontinuation of study intervention and by severityClinicaltrials.govLinkOncologyInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IInfectious DiseasesInfectious Diseas

190、esGlossaryGlossary49OncologyJemperli(dostarlimab)NCT06256588-JADEPhaseIIIPatientParticipants have newly diagnosed unresected locally advanced histologically confirmed HNSCC of the oral cavity,oropharynx,hypopharynx or larynx and completed cisplatin plus radiotherapy(termed CRT in this protocol)with

191、curative intent and has no evidence of distant metastatic disease.Subjects864Treatment armsArm A:dostarlimabArm B:PlaceboDescriptionA randomized,double-blind,placebo-controlled study to evaluate dostarlimab as sequential therapy after chemoradiation in participants with locally advanced unresected h

192、ead and neck squamous cell carcinomaTimelineTrial start:Q1 2024Key end pointsEFS assessed by Blinded Independent Central Review(BICR)Clinicaltrials.govLinkOncologyInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IInfectious DiseasesInfectious DiseasesGlossaryGlossary50OncologyZejula(n

193、iraparib)NCT03602859-FIRSTPhaseIIIPatientParticipants with Stage III or IV nonmucinous epithelial ovarian cancerSubjects1402Treatment armsArm A:SOC(carboplatin+paclitaxel bevacizumab)+placeboArm B:SOC+niraparibArm C:SOC+dostarlimab+niraparibDescriptionA randomised,double-blind comparison of platinum

194、-based therapy with TSR-042 and niraparib versus standard of care platinum-based therapy as first-line treatment of Stage III or IV nonmucinous epithelial ovarian cancerTimelineStudy start:Q4 2018Data reported:Q4 2024Key end pointsPFS and OS for ITT participants.Primary analysis is ARM B vs ARM C.Cl

195、inicaltrials.govLinkNCT04475939-ZEAL-1LPhaseIIIPatientParticipants whose disease has remained stable or responded to 1L platinum-based chemo with pembrolizumab for stage IIIB/IIIC or IV NSCLCSubjects666Treatment armsArm A:niraparib plus pembrolizumabArm B:placebo plus pembrolizumabDescriptionA rando

196、mised,double-blind,placebo-controlled,multicentre study comparing niraparib plus pembrolizumab versus placebo plus pembrolizumab as maintenance therapyTimelineStudy start:Q4 2020Key end pointsPrimary:PFS in CR/PR population assessed by BICR using Response Evaluation Criteria in Solid tumours(RECIST)

197、;key secondary:PFS in ITT,OS in CR/PR,OS ITT,TPP CNSClinicaltrials.govLinkOncologyInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IInfectious DiseasesInfectious DiseasesGlossaryGlossary51OncologyOjjaara/Omjjara(momelotinib)NCT06847867-MIDASPhaseIIPatientParticipants with low-risk mye

198、lodysplastic syndromes(LR-MDS).Subjects80Treatment armsArm A:Dose Optimisation:MomelotinibArm B:Dose Exploration:MomelotinibDescriptionA Phase 2,Randomized,Open-label,Study of Momelotinib in Participants With Anemia Due to Low-risk Myelodysplastic SyndromeTimelineTrial start:Q2 2025Key end pointsPer

199、centage of participants with Red Blood Cells-transfusion independence(RBC-TI)for at least 12 weeks,rolling over 24 weeksSAEs,AEs,Clinicaltrials.govLinkNCT06517875-ODYSSEYPhaseIIPatientParticipants with transfusion dependence(TD)primary myelofibrosis(PMF)or Post-polycythemia vera(PV)/essential thromb

200、ocythemia(ET)myelofibrosis(MF)who are either janus kinase(JAK)inhibitor(JAKi)nave or experiencedSubjects56Treatment armsMomelotinib+LuspaterceptDescriptionA Phase 2 Open-label Study to Evaluate Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Primary or Seconda

201、ry MyelofibrosisTimelineTrial start:Q1 2025Key end pointsPercentage of Participants with TI Response by Week 24,AEs,SAEsClinicaltrials.govLinkOncologyInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IInfectious DiseasesInfectious DiseasesGlossaryGlossary52OncologybelantamabNCT05714839

202、-DREAMM-20PhaseI/IIPatientRelapsed/refractory multiple myeloma(RRMM)Subjects48Treatment armsPart 1:belantamabPart 2:belantamab and BelamafFor both parts,may switch to belantamab mafodotin in case of PDDescriptionAn open-lab multicentre,dose escalation and expansion trial to investigate the safety,to

203、lerability and clinical activity of belantamab as monotherapy and in combination with other treatments in participants with multiple myelomaTimelineTrial start:Q2 2023Key end pointsPart 1:Safety and tolerability(including DLTs),PK and recommended Part 2 dosePart 2:Safety and tolerability,PK,efficacy

204、,and recommended phase II doseClinicaltrials.govLinkOncologyInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IInfectious DiseasesInfectious DiseasesGlossaryGlossary53OncologyGSK4418959NCT06710847-SYLVERPhaseI/IIPatientAdult Participants With Mismatch Repair-deficient(dMMR)or Microsate

205、llite Instability-High(MSI-H)Solid tumoursSubjects73Treatment armsPart 1:GSK4418959 dose escalationPart 2:GSK4418959 dose expansionPart 3:GSK4418959 dose escalation plus PD-1 inhibitorDescriptionAn open-label,multicentre,dose escalation and expansion study of the oral DNA Helicase Werner Inhibitor(W

206、RNi)GSK4418959 alone or in combination with other anti-cancer agentsTimelineTrial start:Q4 2024Key end pointsNumber of participants with dose limiting toxicities(DLTs-DLT observation period-21 days)Treatment emergent adverse events(TEAEs)dose interruption,dose reductions,dose discontinuation within

207、DLT period,and ORR per RECIST 1.1Clinicaltrials.govLinkOncologyInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IInfectious DiseasesInfectious DiseasesGlossaryGlossary54OncologyGSK4524101NCT06077877PhaseI/IIPatientAdult participants with solid tumoursSubjects135Treatment armsArm A,Par

208、t 1:GSK4524101 monotherapyArm B,Part 1:GSK4524101 plus niraparibArm C,Part 1:GSK4524101 food effect cohortArm D,Part 2:GSK4524101 plus niraparibArm E,Part 2:NiraparibDescriptionA first-time-in-human,open-label,multicentre,dose escalation and expansion study of the oral DNA Polymerase Theta inhibitor

209、(POLQi)GSK4524101 and the PARP inhibitor(PARPi)niraparib in adult participants with solid tumoursTimelineTrial start:Q4 2023Key end pointsDLTs,AEs,SAEs,ORRClinicaltrials.govLinkOncologyInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IInfectious DiseasesInfectious DiseasesGlossaryGlos

210、sary55OncologyGSK5733584NCT06431594(BEHOLD-1)PhaseIPatientAdult participants with solid tumoursSubjects240Treatment armsPart 1:Dose escalation with GSK5733584Part 2:Dose expansion with GSK5733584DescriptionA trial to evaluate the safety,tolerability,pharmacokinetics and clinical activity of GSK57335

211、84 for injection in subjects with advanced solid tumoursTimelineTrial start:Q3 2024Key end pointsPart 1:DLTPart 2:ORRClinicaltrials.govLinkNCT06796907(BEHOLD-2)PhaseI/IIPatientParticipants with advanced solid tumours who have either not responded to standard treatments or cannot tolerate them or hav

212、e no available effective treatment.Subjects360Treatment armsArm 1:GSK5733584+Anticancer therapy 1Arm 2:GSK5733584+Anticancer therapy 2Arm 3:GSK5733584+Anticancer therapy 1+Anticancer therapy 2+Anticancer therapy 3Arm 4:GSK5733584+Anticancer therapy 1+Anticancer therapy 2+Anticancer therapy 4Descript

213、ionA trial to evaluate the evaluate the Safety,Tolerability,Pharmacokinetics and Clinical Activity of GSK5733584 in Combination With Anti-Cancer Agents in Participants With Advanced Solid TumoursTimelineTrial start:Q1 2025Key end pointsPart A:DLT,AEs,PFS,ORRPart 2:ORR,OSClinicaltrials.govLinkOncolog

214、yInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IInfectious DiseasesInfectious DiseasesGlossaryGlossary56OncologyGSK5764227NCT06551142PhaseIPatientAdult participants with advanced solid tumoursSubjects281Treatment armsPhase 1a:Dose escalation-GSK5764227 MonotherapyPhase 1a:Dose esca

215、lation-Combination therapy:Biological:GSK5764227Drug:CisplatinDrug:CarboplatinBiological:AtezolizumabBiological:PembrolizumabBiological:DurvalumabBiological:CetuximabBiological:BevacizumabPhase 1b:Dose optimisation/expansion-GSK5764227 MonotherapyDescriptionA Phase 1 Clinical Study to Evaluate the S

216、afety,Tolerability,Pharmacokinetics,and Clinical Activity of GSK5764227 as Monotherapy and in Combination in Participants With Advanced Solid TumorsTimelineTrial start:Q3 2024Key end pointsPhase 1a:AEs,SAEs,DLTsPhase 1b:PFS,ORRClinicaltrials.govLinkOncologyInnovation:Pipeline growthInnovation:Pipeli

217、ne growthHIVHIVRIIRI&IInfectious DiseasesInfectious DiseasesGlossaryGlossary57OncologyGSK6042981(IDRX-42)NCT05489237PhaseIPatientAdult participants with participants with advanced(metastatic and/or surgically unresectable)GIST.Subjects269Treatment armsPhase 1:GSK6042981Phase 1b:Cohort 1:Participants

218、 with GIST progression after first-line imatinib therapyPhase 1b:Cohort 2:Participants with GIST progression after 2 or more lines of TKI therapyPhase 1b:Cohort 3:Participants with GIST who are treatment navePhase 1b:Cohort 4:Participants with GIST progression who meet the same criteria as Cohort 2(

219、third line or greater TKI therapy)and have had prior treatment with investigational agents NB003 or THE-630 or a line of therapy of bezuclastinib plus sunitinib combination.DescriptionA clinical study to evaluate the safety,tolerability,PK,and preliminary antitumor activity of IDRX-42 in adult parti

220、cipants with advanced(metastatic and/or surgically unresectable)GIST.TimelineTrial start:Q1 2022Key end pointsPhase 1:Safety,ORR,PFSPhase 1b:TEAEs,ORR,OSClinicaltrials.govLinkHIVInnovation:Pipeline growthInnovation:Pipeline growthRIIRI&IOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryG

221、lossary58HIVHIVInnovation:Pipeline growthInnovation:Pipeline growthRIIRI&IOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossary59HIVcabotegravir ultra long-acting(ULA)for HIV Prevention NCT06741397PhaseIIbPatientHealthy adolescent and adult participantsSubjects200Treatment armsParti

222、cipants receive lead-in injections comprising cabotegravir LA during month one and injections of a new formulation of CAB LA at Month 3,Month 5 and every 4 months thereafter to Month 29DescriptionA single arm,repeat dose study to evaluate the pharmacokinetic profile,safety,and tolerability of a new

223、formulation of cabotegravir LA injected intramuscularly Q4M in adolescent and adult participants at risk of HIV acquisitionTimelineTrial start:Q4 2024Key end pointsCAB trough concentrationsClinicaltrials.govLinkNCT06786520PhaseIPatientHealthy adult volunteersSubjects60Treatment armsParticipants will

224、 receive the CAB LA Q2M regimen up to Month 9 then will receive the CAB ULA Q4M regimen up to Month 23.DescriptionA single arm,repeat dose study to evaluate the pharmacokinetics,safety,and tolerability of switching to cabotegravir ultra long-acting(CAB ULA)from cabotegravir long-acting(CAB LA)in hea

225、lthy adult volunteersTimelineTrial start:Q1 2025Key end pointsPlasma concentration of CAB at the end of the CAB LA phase compared to plasma concentration of CAB at the end of the CAB ULA phaseClinicaltrials.govLinkHIVInnovation:Pipeline growthInnovation:Pipeline growthRIIRI&IOncologyOncologyInfectio

226、us DiseasesInfectious DiseasesGlossaryGlossary60HIVcabotegravirNCT05418868PhaseIPatientHealthy adult volunteersSubjects180Treatment armsPart A:Participants receiving CAB 200 mg/mL with rHuPH20Part C:Participants receiving CAB 400 mg/mLPart D:Participants receiving CAB 400 mg/mL with rHuPH20Part E:Pa

227、rticipants receiving rilpivirine(RPV)formulation DescriptionA multi-centre,open-label,single dose escalation trial to evaluate the pharmacokinetics,safety and tolerability of long-acting cabotegravir co-administered with recombinant human hyaluronidase PH20(rHuPH20)in healthy adult volunteersTimelin

228、eTrial start:Q2 2022Key end pointsPlasma concentrations of cabotegravir and rilpivirineClinicaltrials.govLinkNCT06033547PhaseIPatientHealthy adult volunteersSubjects56Treatment armsPart A:Participants receiving cabotegravir Formulation FPart B:Participants receiving cabotegravir Formulation GDescrip

229、tionAn open-label,single dose escalation study to evaluate the pharmacokinetics,safety and tolerability of two different formulations of long-acting cabotegravir administered to healthy adult participantsTimelineTrial start:Q3 2023Key end pointsPlasma concentrations of cabotegravirClinicaltrials.gov

230、LinkHIVInnovation:Pipeline growthInnovation:Pipeline growthRIIRI&IOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossaryNCT05996471-EMBRACEPhaseIIbPatientAntiretroviral therapy(ART)-experienced adults living with HIVSubjects135Treatment armsGroup 1:VH3810109 +cabotegravirGroup 2 VH38

231、10109+rHuPH20+cabotegravirGroup 3:Active comparator-Participants receiving standard of care(SOC)antiretroviral therapy(ART)DescriptionA multicentre,randomised,open-label,trial comparing the efficacy,safety,PK,and tolerability of VH3810109,administered either intravenously or as a subcutaneous infusi

232、on with rHuPH20,in combination with cabotegravir given intramuscularly,to standard of care in virologically suppressed,antiretroviral therapy(ART)-experienced adults living with HIVTimelineTrial start:Q3 2023Key end pointsSafety,plasma HIV-1 levelsClinicaltrials.govLink61HIVVH3810109HIVInnovation:Pi

233、peline growthInnovation:Pipeline growthRIIRI&IOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossary62HIVVH4011499NCT06012136PhaseIPatientHealthy adultsSubjects160Treatment armsArm A:VH4004280Arm B:PlaceboArm C:VH4011499DescriptionA double-blind(sponsor-unblinded),placebo-controlled,

234、randomized,single dose escalation study to evaluate the safety,tolerability,and pharmacokinetics of a parenterally administered suspension of investigational capsid inhibitors in healthy adultsTimelineTrial start:Q3 2023Key end pointsAEs,PKClinicaltrials.govLinkNCT06724640PhaseIPatientAdults without

235、 HIVSubjects168Treatment armsVH4011499 Active GroupVH4011499 Placebo GroupDescriptionA double-blind(sponsor-unblinded),placebo-controlled,randomized,single dose escalation study to investigate the safety,tolerability,and pharmacokinetics of parenterally administered long-acting formulations of VH401

236、1499 in adults without HIVTimelineTrial start:Q4 2024Key end pointsAEs,PKClinicaltrials.govLinkHIVInnovation:Pipeline growthInnovation:Pipeline growthRIIRI&IOncologyOncologyInfectious DiseasesInfectious DiseasesGlossaryGlossary63HIVVH4527079NCT06652958PhaseIPatientHealthy adults and persons with HIV

237、Subjects86Treatment armsArm A,Cohort 1:VH4527079 Dose 1(lowest dose)by IV infusion.Arm A,Cohort 2:VH4527079 Dose 2(low dose)by IV infusion.Arm A,Cohort 3:VH4527079 Dose 3(mid-low dose)by IV infusion.Arm A,Cohort 4:VH4527079 Dose 4(mid-high dose)by IV infusion.Arm A,Cohort 5:VH4527079 Dose 5(high dos

238、e)by IV infusion.Arm A,Cohort 6:VH4527079 Dose 6(max dose)by IV infusion.Arm A,Cohort 7:VH4527079 Dose 1(lowest dose)by SC injectionArm B,Cohort 8:three doses of VH4527079 dose that is selected in Arm A,by IV infusion,separated by a time interval.Arm B,Cohort 9:Participants with HIV receive three do

239、ses of VH4527079 dose that is selected in Arm A,by IV infusion,separated by a time interval.DescriptionAn open-label study of the safety and pharmacokinetics of a human monoclonal antibody,VH4527079,administered either intravenously or subcutaneously to healthy adults and persons with HIVTimelineTri

240、al start:Q4 2024Key end pointsSafetyClinicaltrials.govLinkInfectious DiseasesInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IOncologyOncologyGlossaryGlossary64Infectious diseasesInfectious DiseasesInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IOncologyOncologyGloss

241、aryGlossary65Infectious diseasesArexvy(RSV Adults)NCT04732871-RSV OA=ADJ-004 PhaseIIIPatientAdults 60 years of ageSubjects1720Treatment armsArm A:RSVPreF3 OA Day 1,12 months&24 monthsArm B:RSVPreF3 OA Day 1,24 and 48 months Arm C:RSVPreF3 OA Day 1 then follow up,at month 36,re-randomization in 2 gro

242、ups DescriptionA randomised,open-label,multi-country trial to evaluate the immunogenicity,safety,reactogenicity and persistence of a single dose of the RSVPreF3 OA investigational vaccine and different revaccination schedules in adults aged 60 years and aboveTimelineTrial start:Q1 2021Primary data r

243、eported:Q2 2022Key end pointsHumoral immune responseClinicaltrials.govLinkNCT04886596-RSV OA=ADJ-006 PhaseIIIPatientAdults 60 years of ageSubjects26,668Treatment armsArm A:RSVPreF3 OA Lot 1Arm B:RSVPreF3 OA Lot 2Arm C:RSVPreF3 OA Lot 3Arm D:RSVPreF3 OA Lot 4Arm E:PlaceboDescriptionA randomised,place

244、bo-controlled,observer-blind,multi-country trial to demonstrate the efficacy of a single dose and revaccination prior to Season 2 of GSKs RSVPreF3 OA investigational vaccine in adults aged 60 years and aboveTimelineTrial start:Q2 2021Primary data reported:Q2 2022;season two data reported:Q2 2023;sea

245、son three data reported:Q4 2024Key end pointsEfficacy of a single dose and revaccination prior to Season 2 of RSVPreF3 OA vaccine in the prevention of RSV-LRTD in adults 60 YoA Clinicaltrials.govLinkInfectious DiseasesInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IOncologyOncologyG

246、lossaryGlossaryNCT04841577-RSV OA=ADJ-007 PhaseIIIPatientAdults 60 years of ageSubjects976Treatment armsArm A:1 dose of RSVPreF3 OA +1 dose of FLU-QIV on Day 1 Arm B:1 dose of FLU-QIV on Day 1,1 dose of RSVPreF3 OA on Day 31 DescriptionAn open-label,randomised,controlled,multi-country trial to evalu

247、ate the immune response,safety and reactogenicity of RSVPreF3 OA investigational vaccine when co-administered with FLU-QIV vaccine in adults aged 60 years and aboveTimelineTrial start:Q2 2021Primary data reported:Q4 2022Key end pointsHumoral immune response 1 month post vaccination upon co-administr

248、ation compared to the immune response when vaccine is administered alone Clinicaltrials.govLink66Infectious diseasesArexvy(RSV Adults)NCT05559476-RSV OA=ADJ-008PhaseIIIPatientAdults aged 65 years and aboveSubjects1029Treatment armsArm A:1 dose of RSVPreF3 OA+1 dose of Flu-HD on day 1 Arm B:1 dose of

249、 Flu HD on Day 1,1 dose of RSVPreF3 OA on Day 31 DescriptionAn open-label,randomised,controlled,multi-country trial to evaluate the immune response,safety and reactogenicity of RSVPreF3 OA investigational vaccine when co-administered with FLU HD vaccine in adults aged 65 years and aboveTimelineTrial

250、 start:Q4 2022Primary data reported:Q2 2023Key end pointsHumoral immune response 1 month post vaccination upon co-administration compared to the immune response when vaccine is administered alone Clinicaltrials.govLinkInfectious DiseasesInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI

251、&IOncologyOncologyGlossaryGlossary67Infectious diseasesArexvy(RSV Adults)NCT05059301-RSV OA=ADJ-009 PhaseIIIPatientAdults aged 60 years and aboveSubjects770Treatment armsArm A:1 dose of a combination of the RSVPreF3 antigen Lot 1 and AS01E adjuvant Lot A at day 1 Arm B:1 dose of a combination of the

252、 RSVPreF3 antigen Lot 2 and AS01E adjuvant Lot B at day 1 Arm C:1 dose of a combination of the RSVPreF3 antigen Lot 3 and AS01E adjuvant Lot C at Day 1DescriptionA randomised,double-blind,multi-country trial to evaluate consistency,safety and reactogenicity of 3 lots of RSVPreF3 OA investigational v

253、accine administrated as a single dose in adults aged 60 years and aboveTimelineTrial start:Q4 2021Trial end:Q2 2022Key end pointsRSVPreF3-binding IgG concentrations at 1 month post vaccination for three lots of RSVPreF3 OA investigational vaccine Clinicaltrials.govLinkNCT05568797-RSV OA=ADJ-017Phase

254、IIIPatientAdults aged 65 years and aboveSubjects1045Treatment armsArm A:1 dose RSVPreF3 OA investigational vaccine and 1 dose of FLU aQIV vaccine on Day 1Arm B:one dose of Flu aQIV on day 1 and 1 dose of RSVPreF3 OA on day 31 DescriptionAn open-label,randomised,controlled,multi-country trial to eval

255、uate the immune response,safety and reactogenicity of an RSVPreF3 OA investigational vaccine when co-administered with FLU aQIV(inactivated influenza vaccine adjuvanted)in adults aged 65 years and aboveTimelineTrial start:Q4 2022Primary data reported:Q2 2023Key end pointsHumoral immune response 1 mo

256、nth post vaccination upon co-administration compared to the immune response when vaccine is administered alone Clinicaltrials.govLinkInfectious DiseasesInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IOncologyOncologyGlossaryGlossary68Infectious diseasesArexvy(RSV Adults)NCT05590403-

257、RSV OA-018PhaseIIIPatientAdults 50-59 years of age,including adults at increased risk of respiratory syncytial virus lower respiratory tract disease,and older adults 60 years of ageSubjects1544Treatment armsArm A:adults HA-RSVPreF3 OA GroupArm B:adults HA-Placebo GroupArm C:adults AIR-RSVPreF3 OA Gr

258、oupArm D:adults AIR-Placebo GroupArm E:OA-RSVPReF3 OA Group 60 years of age DescriptionAn observer-blind,randomised,placebo-controlled trial to evaluate the non-inferiority of the immune response and safety of the RSVPreF3 OA investigational vaccine in adults 50 59 years of age,including adults at i

259、ncreased risk of respiratory syncytial virus lower respiratory tract disease,compared to older adults 60 years of ageTimelineTrial start:Q4 2022Primary data reported:Q4 2023Key end pointsHumoral immune response in healthy participants 50-59 years of age and in participants 50-59 years of age at incr

260、eased risk of RSV-LRTD compared to OA(60 YoA)Clinicaltrials.govLinkNCT05879107-RSV OA=ADJ-019PhaseIIIPatientAdults 60 years of ageSubjects1113Treatment armsArm A(co-ad group):RSVPreF3 OA investigational vaccine co-administered with PCV20 vaccineArm B(control group):PCV20 vaccine on Day 1 and the RSV

261、PreF3 OA investigational vaccine on Day 31.DescriptionAn open-label,randomised,controlled,multi-country study to evaluate the immune response,safety and reactogenicity of RSVPreF3 OA investigational vaccine when co-administered with PCV20 in adults aged 60 years and olderTimelineTrial start:Q2 2023K

262、ey end pointsOpsonophagocytic antibody titers for each of the pneumococcal vaccine serotypes and RSV-A&RSV-B serum neutralizing titersClinicaltrials.govLinkInfectious DiseasesInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IOncologyOncologyGlossaryGlossaryNCT05966090-RSV OA=ADJ-020Ph

263、aseIIIPatientAdults aged 50 years and olderSubjects530Treatment armsArm A:Participants will be administered first dose of HZ/su vaccine and the RSVPreF3 OA investigational vaccine together on Day 1.A second dose of the HZ/su vaccine will be administered at Day 61.Arm B:Participants will be administe

264、red first dose HZ/su vaccine on Day 1,followed by the RSVPreF3 OA investigational vaccine on Day 31,and then second dose of HZ/su vaccine on Day 61.DescriptionAn open-label,randomised,controlled,multi-country study to evaluate the immune response,safety and reactogenicity of RSVPreF3 OA investigatio

265、nal vaccine when co-administered with Herpes Zoster recombinant subunit(HZ/su)vaccine in adults aged 50 years and olderTimelineTrial start:Q3 2023Primary data reported:Q3 2024Key end pointsAnti-gE antibody concentrations expressed as group geometric mean concentration ratioRSV-A&-B serum neutralizin

266、g titers expressed as group geometric mean titerClinicaltrials.govLink69Infectious diseasesArexvy(RSV Adults)NCT05921903-RSV OA=ADJ-023PhaseIIbPatientImmunocompromised(IC)adults 50 years of age and aboveSubjects387Treatment armsArm A:RSV_IC_1 group,IC patients receiving 1 dose of RSVPreF3 OA investi

267、gational vaccine at Visit 1(Day 1).Arm B:RSV_IC_2 group,IC patients receiving 2 doses of RSVPreF3 OA investigational vaccine at Visit 1(Day 1)and Visit 3(Visit 1+30-60 days)Arm C:RSV_HA group,healthy participants receiving 1 dose of RSVPreF3 OA investigational vaccine at Visit 1(Day 1).DescriptionA

268、randomised,controlled,open-label trial to evaluate the immune response and safety of the RSVPreF3 OA investigational vaccine in adults(50 years of age)when administered to lung and renal transplant recipients comparing one versus two doses and compared to healthy controls(50 years of age)receiving o

269、ne doseTimelineTrial start:Q3 2023Primary data reported:Q4 2024Key end pointsRSV-A&-B serum neutralizing titers expressed as mean geometric increase post Dose 2 over post Dose 1Clinicaltrials.govLinkInfectious DiseasesInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IOncologyOncologyG

270、lossaryGlossary70Infectious diseasesArexvy(RSV Adults)NCT06374394-RSV OA=ADJ-013PhaseIIIPatientAdults aged 50 years and aboveSubjects842Treatment armsRSVPreF3 OA investigational vaccineCOVID-19 mRNA vaccineDescriptionAn open-label,randomized,controlled study to evaluate the immune response,safety an

271、d reactogenicity of RSVPreF3 OA investigational vaccine when co-administered with a COVID-19 mRNA vaccine(Omicron XBB.1.5)TimelineTrial start:Q2 2024Key end pointsRSV-A,RSV-B neutralization titersSARS-CoV-2 Omicron XBB.1.5 neutralization titersClinicaltrials.govLinkNCT06389487-RSV OA=ADJ-025PhaseIII

272、bPatientAdult participants,18-49 YOA,at increased risk(AIR)for RSV disease and older adults(OA)participants,=60 YOASubjects1458Treatment armsPart A:RSV-A-AIR Group,RSVPreF3 OA investigational vaccinePart A:RSV-OA Group,RSVPreF3 OA investigational vaccinePart B:RSV-A-AIR Group,RSVPreF3 OA investigati

273、onal vaccineDescriptionAn open-label study to evaluate the non-inferiority of the immune response and to evaluate the safety of the RSVPreF3 OA investigational vaccine in adults 18-49 years of age at increased risk for Respiratory Syncytial Virus disease,compared to older adults=60 years of ageTimel

274、ineTrial start:Q2 2024Primary data reported:Q3 2024Key end pointsRSV-A,RSV-B neutralizing titersSeroresponse rate(SRR)in RSV-A and RSV-B neutralizing titersClinicaltrials.govLinkInfectious DiseasesInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IOncologyOncologyGlossaryGlossary71Infe

275、ctious diseasesArexvy(RSV Adults)NCT06551181-RSV OA=ADJ-021PhaseIIIPatientAdults aged 60 years and aboveSubjects2600Treatment armsOverseas:RSVPreF3 OA investigational vaccineChina:RSVPreF3 OA investigational vaccineChina:PlaceboDescriptionA study on the immune response,safety and the occurrence of R

276、espiratory Syncytial Virus(RSV)-associated respiratory tract illness after administration of RSV OA vaccine in adults 60 years and olderTimelineTrial start:Q3 2024Key end pointsRSV-A,RSV-B neutralization titersSeroresponse rate(SRR)in RSV-A and RSV-B neutralizing titersClinicaltrials.govLinkNCT06534

277、892 RSV-OA=ADJ-012PhaseIIIbPatientAdults aged 60 years and aboveSubjects12000Treatment armsRSV_PreS4:Participants in this group will receive 1 dose of RSVPreF3 OA vaccine before RSV Season 4.RSV_PreS5:Participants in this group will receive 1 dose of RSVPreF3 OA vaccine before RSV Season 5.RSV_1Dose

278、:Participants in this group will not receive any additional dose of RSV PreF3 OA vaccine.DescriptionA randomized,open label,multicountry,multi-center,extension and crossover vaccination study to evaluate the immunogenicity and safety of different revaccination schedules and persistence of a single d

279、ose of the RSVPreF3 OA vaccine in adults aged 60 years and above who participated in the RSV OA=ADJ-006 studyTimelineTrial start:Q3 2024Key end pointsRSV-A,RSV-B neutralization titersClinicaltrials.govLinkInfectious DiseasesInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IOncologyOnc

280、ologyGlossaryGlossary72Infectious diseasesbepirovirsenNCT05630807-B-WELL 1PhaseIIIPatientNon-cirrhotic nucleos(t)ide analogue treated patients with chronic hepatitis B virusSubjects941Treatment armsArm A:bepirovirsen for 24 weeksArm B:placeboDescriptionA multicentre,randomised,double blind trial to

281、confirm the efficacy and safety of treatment with bepirovirsen in participants with chronic hepatitis B virusTimelineTrial start:Q4 2022Key end pointsNumber of participants with baseline HBsAg 3000IU/mL achieving functional cure(FC)Clinicaltrials.govLinkNCT05630820-B-WELL 2PhaseIIIPatientNon-cirrhot

282、ic nucleos(t)ide analogue treated patients with chronic hepatitis B virusSubjects871Treatment armsArm A:bepirovirsen for 24 weeksArm B:placeboDescriptionA multicentre,randomised,double blind trial to confirm the efficacy and safety of treatment with bepirovirsen in participants with chronic hepatiti

283、s B virusTimelineTrial start:Q4 2022Key end pointsNumber of participants with baseline HBsAg 3000IU/mL achieving functional cure(FC)Clinicaltrials.govLinkInfectious DiseasesInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IOncologyOncologyGlossaryGlossary73Infectious diseasesBlujepa(g

284、epotidacin)NCT04020341-EAGLE 2PhaseIIIPatientFemales with uUTI/acute cystitisSubjects1531Treatment armsArm A:1500 mg BID gepotidacin+placebo x 5 daysArm B:100 mg BID nitrofurantoin+placebo x 5 daysDescriptionA randomised,multicentre,parallel-group,double-blind,double-dummy trial in adolescent and ad

285、ult female participants comparing the efficacy and safety of gepotidacin to nitrofurantoin in the treatment of uncomplicated urinary tract infection(acute cystitis)TimelineTrial start:Q4 2019Data reported:Q2 2023Key end pointsNumber of participants with therapeutic response(combined per participant

286、clinical and microbiological response)Clinicaltrials.govLinkNCT04187144-EAGLE 3PhaseIIIPatientFemales with uUTI/acute cystitisSubjects1606Treatment armsArm A:1500 mg BID gepotidacin+placebo x 5 daysArm B:100 mg BID nitrofurantoin+placebo x 5 daysDescriptionA randomised,multicentre,parallel-group,dou

287、ble-blind,double-dummy trial in adolescent and adult female participants comparing the efficacy and safety of gepotidacin to nitrofurantoin in the treatment of uncomplicated urinary tract infection(acute cystitis)TimelineTrial start:Q2 2020Data reported:Q2 2023Key end pointsNumber of participants wi

288、th therapeutic response(combined per participant clinical and microbiological response)Clinicaltrials.govLinkInfectious DiseasesInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IOncologyOncologyGlossaryGlossary74Infectious diseasesBlujepa(gepotidacin)NCT04010539-EAGLE 1PhaseIIIPatient

289、Uncomplicated urogenital gonorrhoea caused by Neisseria gonorrhoeaeSubjects628Treatment armsArm A:2 x 3000 mg gepotidacin for one dayArm B:ceftriaxone(500mg IM),1 g azithromycinDescriptionA randomised,multicentre,open-label trial in adolescent and adult participants comparing the efficacy and safety

290、 of gepotidacin to ceftriaxone plus azithromycin in the treatment of uncomplicated urogenital gonorrhoea caused by Neisseria gonorrhoeaeTimelineTrial start:Q4 2019Data reported:Q1 2024Key end pointsNumber of participants with culture-confirmed bacterial eradication 4-8 days post treatmentClinicaltri

291、als.govLinkInfectious DiseasesInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IOncologyOncologyGlossaryGlossary75Infectious diseasesGSK4178116(Varicella new strain)NCT06693895PhaseIIIPatientHealthy children aged 12 to 15 monthsSubjects750Treatment armsParticipants receive 1 dose of a

292、 VNS vaccine,1 dose of measles,mumps,and rubella(MMR)vaccine,1 dose of hepatitis A(HAV)vaccine,and 1 dose of PCV(either PCV 13 or Vaxneuvance or PCV 20)on Day 1.Participants receive 1 dose of a marketed VV,1 dose of MMR vaccine,1 dose of HAV vaccine,and 1 dose of PCV(either PCV 13 or Vaxneuvance or

293、PCV 20)on Day 1.DescriptionA Phase 3a,observer-blind,randomized,controlled study to evaluate the safety of an investigational varicella vaccine compared with Varivax,administered as a first dose to healthy children 12 to 15 months of ageTimelineTrial start:Q4 2024Key end pointsAEs,SAEsClinicaltrials

294、.govLinkNCT06740630PhaseIIIPatientHealthy children 12 to 15 months of ageSubjects1840Treatment armsParticipants receive 1 dose of the investigational VNS vaccine of Lot 1 or Lot 2 or Lot 3,1 dose of measles,mumps,and rubella(MMR)vaccine,1 dose of hepatitis A vaccine(HAV),and 1 dose of PCV(either PCV

295、 13 or Vaxneuvance or PCV 20)on Day 1.Participants receive 1 dose of a marketed varicella vaccine(VV)of Lot 1 or Lot 2,1 dose of MMR vaccine,1 dose of HAV vaccine,and 1 dose of PCV(either PCV 13 or Vaxneuvance or PCV 20)on Day 1.DescriptionA Phase 3a,observer-blind,randomized,controlled study to dem

296、onstrate lot-to-lot consistency and evaluate the immunogenicity and safety of an investigational varicella vaccine compared with Varivax,administered as a first dose to healthy children 12 to 15 months of ageTimelineTrial start:Q1 2025Key end pointsAnti-glycoprotein-E antibodies at day 43Clinicaltri

297、als.govLinkInfectious DiseasesInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IOncologyOncologyGlossaryGlossary76Infectious diseasesGSK4178116(Varicella new strain)NCT06806137PhaseIIIPatientHealthy children aged 12 to 15 monthsSubjects600Treatment armsParticipants receive 2 doses of

298、a VV vaccine on Day 1 and Day 91.1 dose of measles,mumps,and rubella(MMR)vaccine,1 dose of hepatitis A vaccine(HAV),and 1 dose of PCV(either PCV 13 or Vaxneuvance or PCV 20)on Day 1.Participants receive 2 doses of a VNS vaccine on Day 1 and Day 91.1 doses of MMR vaccine,1 dose of HAV vaccine,and 1 d

299、ose of PCV(either PCV 13,Vaxneuvance or PCV 20)on Day 1.Participants receive 1 dose of VV vaccine on Day 1,1 dose of VNS Vaccine on Day 91.1 doses of MMR vaccine,1 dose of HAV,and 1 dose of PCV(either PCV 13,Vaxneuvance or PCV 20)on Day 1.DescriptionA Phase 3a,Observer-blind,Randomized,Controlled,St

300、udy to Evaluate the Immunogenicity and Safety of an Investigational Varicella Vaccine Compared With Varivax,When Given as a Second Dose to Healthy Children,3 Months After the Administration of a First Dose at 12 to 15 Months of AgeTimelineTrial start:Q1 2025Key end points%of participants with serore

301、sponse to Varicella Zoster Virus(VZV)anti-glycoprotein E(gE)IgG and Geometric Mean Concentration(GMC)of anti-VZV gE IgG for 2 doses of VNS vaccine compared to 2 doses of VV Clinicaltrials.govLinkNCT06855160PhaseIIIPatientHealthy children 12 to 15 months of ageSubjects900Treatment armsParticipants re

302、ceive 1 dose of the candidate varicella vaccine(VNS vaccine),1 dose of a measles,mumps,and rubella(MMR)vaccine,1 dose of a hepatitis A virus(HAV vaccine),and 1 dose of PCV(either PCV 13 or Vaxneuvance or PCV 20)on Day 1.Participants receive 1 dose of a Marketed varicella vaccine(VV),1 dose of a MMR

303、vaccine,1 dose of a HAV vaccine,and 1 dose of PCV(either PCV 13 or Vaxneuvance or PCV 20)on Day 1.DescriptionA Phase 3a,Open-Label,Randomized,Controlled Study to Evaluate the Immunogenicity and Safety of Intramuscular Administration of an Investigational Varicella Vaccine and Priorix Compared With S

304、ubcutaneous Administration of Varivax and Priorix,When Given as a First Dose to Healthy Children 12 to 15 Months of AgeTimelineTrial start:Q2 2025Key end pointsPercentage of participants with seroresponse to Varicella Zoster Virus(VZV)anti-glycoprotein E(gE)Immunoglobulin(IgG),AEs,SAEsClinicaltrials

305、.govLinkInfectious DiseasesInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IOncologyOncologyGlossaryGlossary77Infectious diseasesganfeboroleNCT05382312PhaseIIaPatientMales and females aged 18 to 65 years inclusive with drug-sensitive(rifampicin-susceptible)pulmonary tuberculosisSubje

306、cts128Treatment armsArm A:Participants receiving GSK3036656+bedaquilineArm B:Participants receiving GSK3036656+delamanidArm C:Participants receiving bedaquiline+delamanidArm D:Participants receiving RIFAFOUR e-275DescriptionA parallel group,randomised,open-label,4 treatment arm trial to assess the e

307、arly bactericidal activity,safety and tolerability of oral GSK3036656 in combination with either oral delamanid or oral bedaquiline,oral delamanid in combination with oral bedaquiline,or standard of care in males and females aged 18 to 65 years inclusive with drug-sensitive(rifampicin-susceptible)pu

308、lmonary tuberculosisTimelineTrial start:Q3 2022Key end pointsChange from baseline in log10 CFU of Mycobacterium tuberculosisClinicaltrials.govLinkInfectious DiseasesInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IOncologyOncologyGlossaryGlossaryNCT05073003PhaseI/IIPatientAdults in E

309、urope(Stage 1)followed by age de-escalation from adults to children and infants and dose finding in infants in Africa(Stage 2)Subjects550 Treatment armsDrug:altSonflex Placebo(adults stage 1 in Europe)Biological:altSonflex1-2-3 High Dose C(adults stage 1 in Europe,adults,children and infants stage 2

310、 in Africa)Biological:altSonflex1-2-3 Medium Dose B(children and infants stage 2 in Africa)Biological:altSonflex1-2-3 Low Dose A(infants stage 2 in Africa)Comparators:Menveo and Boostrix(adults stage 2 in Africa)Comparators:Menveo and Typhim Vi(children stage 2 in Africa)Comparators:Menveo and Infan

311、rix(infants stage 2 in Africa)DescriptionA staged observer-blind,randomised,controlled,multi-country trial to evaluate the safety,reactogenicity,and immune responses to the GVGH altSonflex1-2-3 vaccine against S.sonnei and S.flexneri serotypes 1b,2a,and 3a,in adults in Europe(Stage 1)followed by age

312、 de-escalation from adults to children and infants,and dose-finding in infants in Africa(Stage 2)TimelineTrial start:Q4 2021Key end pointsImmune response to identify the preferred dose of each component of the altSonflex1-2-3 vaccine(low,medium,or high)for infants 9 months of age in Africa(Stage 2).

313、To evaluate the safety and reactogenicity of the altSonflex1-2-3 vaccine in all participants in Europe and Africa(Stage 1 and Stage 2)Clinicaltrials.govLink78Infectious diseasesGSK3536852(Shigella)Infectious DiseasesInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IOncologyOncologyGlo

314、ssaryGlossary79Infectious diseasesGSK3993129(Cytomegalovirus)NCT05089630PhaseI/IIPatientHealthy adults 18 to 50 years of ageSubjects333Treatment armsArm A:pentamer(low)/gB(low)/adjuvant vaccineArm B:pentamer(med)/gB(low)/adjuvant vaccineArm C:pentamer(med)/gB(med)/adjuvant vaccineArm D:pentamer(high

315、)/gB(med)/adjuvant vaccineArm E:placebo(saline)DescriptionA randomised,observer-blind,placebo-controlled,dose escalation trial to assess safety,reactogenicity and immunogenicity of a candidate CMV vaccine comprising recombinant protein and adjuvantTimelineTrial start:Q4 2021Key end pointsSafety,reac

316、togenicity and immunogenicityClinicaltrials.govLinkInfectious DiseasesInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IOncologyOncologyGlossaryGlossary80Infectious diseasesGSK4023393(MenABCWY,2nd Gen)NCT05082285PhaseIIPatientHealthy infantsSubjects724Treatment armsCombination Product

317、:MenABCWY-2Gen low dose vaccineCombination Product:MenABCWY-2Gen high dose vaccineCombination Product:MenABCWYCombination Product:MenB+MenACWY-TTDescriptionA randomised,partially blinded trial to assess the safety,tolerability and immunogenicity of meningococcal combined ABCWY vaccine when administe

318、red to healthy infantsTimelineTrial start:Q4 2021Key end pointsAEs,including all SAEs,AEs leading to withdrawal and AEs of special interest(AESIs),medical attended events(MAE)Immunogenicity by hSBA to indicator strainsClinicaltrials.govLinkInfectious DiseasesInnovation:Pipeline growthInnovation:Pipe

319、line growthHIVHIVRIIRI&IOncologyOncologyGlossaryGlossary81Infectious diseasesGSK4077164(iNTS Typhimurium+Enteritidis)NCT05480800 PhaseI/IIaPatientHealthy European and African adultsSubjects155Treatment armsArm A:iNTS-TCV low dose group-EuropeArm B:iNTS-GMMA and TCV low doses group-EuropeArm C:Step 1

320、 group(placebo)-EuropeArm D:iNTS-TCV full dose_1 group-EuropeArm E:iNTS-GMMA and TCV full doses_1 group-EuropeArm F:Step 2 group(placebo)-EuropeArm G:iNTS-TCV full dose_2 group-AfricaArm H:iNTS-GMMA and TCV full doses_2 group-AfricaArm I:Stage 2 group(control)-AfricaDescriptionAn observer-blind,rand

321、omised,controlled,two-stage,multi-country trial to evaluate the safety,reactogenicity and immune response of the trivalent vaccine against iNTS and Typhoid feverTimelineTrial start:Q3 2022Key end pointsTo evaluate the safety,reactogenicity and immunogenicity profile of iNTS-TCV vaccine in healthy Eu

322、ropean/African adultsClinicaltrials.govLinkInfectious DiseasesInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IOncologyOncologyGlossaryGlossary82Infectious diseasesGSK4382276(mRNA Seasonal Flu)NCT05823974PhaseI/IIPatientHealthy younger and older adultsSubjects1256Treatment armsBiolog

323、ical:Flu mRNACombination Product:Control 1Combination Product:Control 2DescriptionA randomized,dose-finding/dose-confirmation study to evaluate the reactogenicity,safety and immunogenicity of mRNA-based multivalent seasonal influenza vaccine candidates administered in healthy younger and older adult

324、sTimelineTrial start:Q2 2023Key end pointsSafety and reactogenicity,including number of participants reporting systemic and solicited administration site eventsSerum anti-influenza antigen seroconversion rates and geometric mean titersClinicaltrials.govLinkNCT06431607PhaseIIaPatientAdults 18 years o

325、f age and olderSubjects843Treatment armsFlu mRNA_YA_Groups:Formulations 1,2,3,4YA_Active Comparator Group 1:Active Comparator 1Flu mRNA_OA_Groups:Formulation 5,6,7,8OA_Active Comparator Group 2:Active Comparator 2Flu mRNA_YA_Group:Formulation 9YA_Active Comparator Group 3:Active Comparator 3Flu mRNA

326、_OA_Group 5:Formulation 10OA_Active Comparator Group 4:Comparator 4DescriptionA randomized,observer-blind,dose-finding study to evaluate the immunogenicity and safety of mRNA-based multivalent seasonal influenza vaccine candidates in adults 18 years of age and olderTimelineTrial start:Q2 2024Key end

327、 pointsAntigen 1 antibody titresClinicaltrials.govLinkInfectious DiseasesInnovation:Pipeline growthInnovation:Pipeline growthHIVHIVRIIRI&IOncologyOncologyGlossaryGlossary83Infectious diseasesGSK4406371(MMRV new strain vaccine)NCT05630846PhaseIIPatientHealthy children 4-6 years of ageSubjects801Treat

328、ment armsInvestigational MMRV(H)NS vaccineInvestigational MM(H)RVNS vaccineInvestigational M(L)M(L)R(L)V(L)NS vaccineMarketed MMRV_Lot 1 and Lot 2 vaccineDescriptionA single-blind,randomized,controlled trial to evaluate the immunogenicity and safety of a measles,mumps,rubella,varicella vaccine compa

329、red with ProQuad,administered in healthy children 4-6 years of ageTimelineTrial start:Q4 2022Key end pointsAnti-measles,anti-mumps,anti-rubella,and anti-glycoprotein H antibodies geometric mean concentrationsClinicaltrials.govLinkInfectious DiseasesInnovation:Pipeline growthInnovation:Pipeline growt

330、hHIVHIVRIIRI&IOncologyOncologyGlossaryGlossary84Infectious diseasesGSK5101955(Paediatric Pneumococcal disease)NCT05412030 PhaseIIPatientHealthy infantsSubjects472Treatment armsArm A:1 mcg AFX3772 administered intramuscularly 4 times within 12 monthsArm B:2 mcg AFX3772 administered intramuscularly 4

331、times within 12 monthsArm C:5 mcg AFX3772 administered intramuscularly 4 times within 12 monthsArm D:PCV13 and PCV20 administered intramuscularly 4 times within 12 monthsDescriptionA randomised,double-blind,multi-dose,dose finding trial to evaluate the safety,tolerability and immunogenicity of AFX37

332、72 compared with PCV13 and PCV20 in healthy infantsTimelineTrial start:Q2 2022Key end pointsSafety,tolerability profiles of 3 different dose levels of AFX3772 compared with PCV13 and PCV20 with respect to the proportion of participants with AEsClinicaltrials.govLinkInfectious DiseasesInnovation:Pipe

333、line growthInnovation:Pipeline growthHIVHIVRIIRI&IOncologyOncologyGlossaryGlossary85Infectious diseasesGSK5536522(mRNA Flu H5N1 pre-pandemic)NCT06382311PhaseI/IIPatientHealthy younger and older adultsSubjects1080Treatment armsPhase 1 cohort 1:Flu Pandemic mRNA(5 dose levels)and placeboPhase 1 cohort 2:Flu Pandemic mRNA(5 dose levels)and placeboPhase 2 Part A cohort 3:Flu Pandemic mRNA(5 dose level