2023
Pembrolizumab plus docetaxel for patients with metastatic castration-resistant prostate cancer (mCRPC): Randomized, double-blind, phase 3 KEYNOTE-921 study.
Petrylak D, Ratta R, Matsubara N, Korbenfeld E, Gafanov R, Mourey L, Todenhöfer T, Gurney H, Kramer G, Bergman A, Zalewski P, De Santis M, Armstrong A, Gerritsen W, Pachynski R, Byun S, Li X, Schloss C, Poehlein C, Fizazi K. Pembrolizumab plus docetaxel for patients with metastatic castration-resistant prostate cancer (mCRPC): Randomized, double-blind, phase 3 KEYNOTE-921 study. Journal Of Clinical Oncology 2023, 41: 19-19. DOI: 10.1200/jco.2023.41.6_suppl.19.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerNext-generation hormonal agentsDual primary endpointsTreatment-related AEsCycles of docetaxelPrimary endpointSecondary endpointsDocetaxel armRadiographic progression-free survivalCastration-resistant prostate cancerBlinded independent central reviewCycles of placeboData cutoff dateSafety of pembrolizumabSubsequent anticancer therapyTreatment-related deathsAndrogen deprivation therapyECOG performance statusKey secondary endpointProgression-free survivalIndependent central reviewEligible ptsDeprivation therapyRECIST 1.1Baseline characteristics
2020
343 Phase 3 study of pembrolizumab + docetaxel and prednisone/prednisolone for metastatic castration-resistant prostate cancer (mCRPC) pretreated with next-generation hormonal agents (NHAs) (KEYNOTE-921)
Petrylak D, Shore N, Bennamoun M, Ratta R, Piulats J, Li B, Schloss C, Fizazi K. 343 Phase 3 study of pembrolizumab + docetaxel and prednisone/prednisolone for metastatic castration-resistant prostate cancer (mCRPC) pretreated with next-generation hormonal agents (NHAs) (KEYNOTE-921). Journal For ImmunoTherapy Of Cancer 2020, 8: a209-a210. DOI: 10.1136/jitc-2020-sitc2020.0343.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerNext-generation hormonal agentsPrednisone/prednisoloneProgression-free survivalObjective response rateDuration of responseSecondary end pointsOverall survivalDisease progressionResponse ratePrior treatmentRECIST v1.1End pointAbiraterone acetateEastern Cooperative Oncology Group performance status 0/1Prostate-specific antigen (PSA) response rateDual primary end pointsKey secondary end pointRadiographic progression-free survivalCastration-resistant prostate cancerPerformance status 0/1PSA response rateSubsequent anticancer therapyAndrogen deprivation therapyPrimary end pointPhase III study of pembrolizumab (pembro) plus docetaxel and prednisone for enzalutamide (enza)- or abiraterone acetate (abi)–pretreated patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): KEYNOTE-921.
Petrylak D, Shore N, Bennamoun M, Ratta R, Piulats J, Li B, Schloss C, Fizazi K. Phase III study of pembrolizumab (pembro) plus docetaxel and prednisone for enzalutamide (enza)- or abiraterone acetate (abi)–pretreated patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): KEYNOTE-921. Journal Of Clinical Oncology 2020, 38: tps262-tps262. DOI: 10.1200/jco.2020.38.6_suppl.tps262.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerPrednisone/prednisoloneRECIST v1.1Prostate Cancer Working Group 3Castration-resistant prostate cancerEnd pointAdequate organ functionECOG PS 0Months of screeningPSA response rateSubsequent anticancer therapyAndrogen deprivation therapyPD-1 inhibitorsPrimary end pointSecondary end pointsSingle-agent antitumor activityPhase 3 trialPhase III studyDeprivation therapyPSA progressionUnacceptable toxicityAbiraterone acetateIII studyMetastasis locationPS 0
2019
891TiP KEYNOTE-921: Phase III study of pembrolizumab (pembro) plus docetaxel and prednisone for enzalutamide (enza)- or abiraterone (abi)-pretreated patients (pts) with metastatic castration-resistant prostate cancer (mCRPC)
Petrylak D, Li B, Schloss C, Fizazi K. 891TiP KEYNOTE-921: Phase III study of pembrolizumab (pembro) plus docetaxel and prednisone for enzalutamide (enza)- or abiraterone (abi)-pretreated patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). Annals Of Oncology 2019, 30: v351. DOI: 10.1093/annonc/mdz248.048.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerPrednisone/prednisoloneAndrogen deprivation therapySubsidiary of MerckDohme Corp.Merck SharpKey secondary efficacy end pointsRadiographic progression-free survivalRandomized phase 3 trialSecondary efficacy end pointsCastration-resistant prostate cancerAdequate organ functionECOG PS 0/1Subsequent anticancer therapyEfficacy end pointPhase 3 trialProgression-free survivalRadiographic disease progressionCT/MRIBristol-Myers SquibbAdult ptsDeprivation therapyPS 0/1RECIST v1.1Unacceptable toxicity