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