2024
ARV-766, a proteolysis targeting chimera (PROTAC) androgen receptor (AR) degrader, in metastatic castration-resistant prostate cancer (mCRPC): Initial results of a phase 1/2 study.
Petrylak D, McKean M, Lang J, Gao X, Dreicer R, Geynisman D, Stewart T, Gandhi M, Appleman L, Dorff T, Chatta G, Tutrone R, De La Cerda J, Berghorn E, Gong J, Yu T, Dominy E, Chan E, Shore N. ARV-766, a proteolysis targeting chimera (PROTAC) androgen receptor (AR) degrader, in metastatic castration-resistant prostate cancer (mCRPC): Initial results of a phase 1/2 study. Journal Of Clinical Oncology 2024, 42: 5011-5011. DOI: 10.1200/jco.2024.42.16_suppl.5011.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerTreatment-related adverse eventsAR-LBD mutationsPhase 1/2 studyClinical activityProstate cancerAndrogen receptorAdverse eventsMetastatic castration-resistant prostate cancer treatmentProgressive metastatic castration-resistant prostate cancerPhase 1 dose-escalation portionDisease progressionTreatment-emergent adverse eventsCastration-resistant prostate cancerResistant to available therapiesAssociated with poor outcomesDose-limiting toxicityAndrogen deprivation therapyAdvanced prostate cancerIncreased blood creatinineWild-type ARSubgroup of patientsDose-dependent increaseDeprivation therapyPretreated patients
2023
The Efficacy of Enzalutamide plus Androgen Deprivation Therapy in Oligometastatic Hormone-sensitive Prostate Cancer: A Post Hoc Analysis of ARCHES
Armstrong A, Iguchi T, Azad A, Villers A, Alekseev B, Petrylak D, Szmulewitz R, Alcaraz A, Shore N, Holzbeierlein J, Gomez-Veiga F, Rosbrook B, Zohren F, Haas G, Gourgiotti G, El-Chaar N, Stenzl A. The Efficacy of Enzalutamide plus Androgen Deprivation Therapy in Oligometastatic Hormone-sensitive Prostate Cancer: A Post Hoc Analysis of ARCHES. European Urology 2023, 84: 229-241. PMID: 37179240, DOI: 10.1016/j.eururo.2023.04.002.Peer-Reviewed Original ResearchConceptsHormone-sensitive prostate cancerAndrogen deprivation therapyRadiographic progression-free survivalMetastatic hormone-sensitive prostate cancerOligometastatic hormone-sensitive prostate cancerOverall survivalProstate cancerDeprivation therapyHazard ratioAndrogen receptor inhibitionEarly treatment intensificationEfficacy of enzalutamideRisk of undertreatmentSystemic treatment strategiesSecondary efficacy endpointsPhase 3 studyProgression-free survivalNumber of metastasesConfidence intervalsProportional hazards modelPost Hoc AnalysisEfficacy endpointOligometastatic diseaseSecondary endpointsTreatment intensificationFirst-in-human, phase 1 study of PF-06753512, a vaccine-based immunotherapy regimen (VBIR), in non-metastatic hormone-sensitive biochemical recurrence and metastatic castration-resistant prostate cancer (mCRPC)
Autio K, Higano C, Nordquist L, Appleman L, Zhang T, Zhu X, Babiker H, Vogelzang N, Prasad S, Schweizer M, Madan R, Billotte S, Cavazos N, Bogg O, Li R, Chan K, Cho H, Kaneda M, Wang I, Zheng J, Tang S, Hollingsworth R, Kern K, Petrylak D. First-in-human, phase 1 study of PF-06753512, a vaccine-based immunotherapy regimen (VBIR), in non-metastatic hormone-sensitive biochemical recurrence and metastatic castration-resistant prostate cancer (mCRPC). Journal For ImmunoTherapy Of Cancer 2023, 11: e005702. PMID: 36948505, PMCID: PMC10040068, DOI: 10.1136/jitc-2022-005702.Peer-Reviewed Original ResearchConceptsMetastatic castration-resistant prostate cancerAndrogen deprivation therapyRadiographic progression-free survivalCastration-resistant prostate cancerPhase 1 studyBiochemical recurrenceProstate cancerImmunotherapy regimenMedian durationDose escalationMedian radiographic progression-free survivalAntigen-specific T cell responsesImmune-related adverse eventsRecommended phase 2 doseSpecific T cell responsesPhase 2 doseImmune checkpoint inhibitorsModest antitumor activityObjective response rateProgression-free survivalAntigen-specific immunityT cell responsesInfluenza-like illnessSignificant side effectsDeprivation therapyA phase 2 expansion study of ARV-766, a PROTAC androgen receptor (AR) degrader, in metastatic castration-resistant prostate cancer (mCRPC).
Petrylak D, Stewart T, Gao X, Berghorn E, Lu H, Chan E, Gedrich R, Lang J, McKean M. A phase 2 expansion study of ARV-766, a PROTAC androgen receptor (AR) degrader, in metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2023, 41: tps290-tps290. DOI: 10.1200/jco.2023.41.6_suppl.tps290.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerNovel hormonal agentsCohort expansionDisease progressionEastern Cooperative Oncology Group performance status scoreOngoing androgen deprivation therapyProstate-specific antigen (PSA) declineCastration-resistant prostate cancerGonadotropin-releasing hormone analogueCohort expansion studyAndrogen deprivation therapyPerformance status scoreOverall response ratePhase 1 portionWild-type ARDeprivation therapyPrior chemotherapyCurative optionDose escalationAvailable therapiesHormonal agentsStatus scoreCurrent therapiesLigand-binding domainClinical trialsPembrolizumab 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
2022
1398P Overall survival (OS) in patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC) who received prior androgen deprivation therapy (ADT) and reached low prostate-specific antigen (PSA) levels treated further with enzalutamide (ENZA): Post hoc analyses of ARCHES
Petrylak D, Azad A, Szmulewitz R, Iguchi T, Shore N, Holzbeierlein J, Alekseev B, El-Chaar N, Rosbrook B, Ma J, Zohren F, Haas G, Stenzl A, Armstrong A. 1398P Overall survival (OS) in patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC) who received prior androgen deprivation therapy (ADT) and reached low prostate-specific antigen (PSA) levels treated further with enzalutamide (ENZA): Post hoc analyses of ARCHES. Annals Of Oncology 2022, 33: s1183-s1184. DOI: 10.1016/j.annonc.2022.07.1884.Peer-Reviewed Original ResearchMetastatic hormone-sensitive prostate cancerAndrogen deprivation therapyOverall survivalLow prostate-specific antigen levelsHormone-sensitive prostate cancerPrior androgen deprivation therapyProstate-specific antigen levelDeprivation therapyAntigen levelsProstate cancerEnzalutamidePatientsTherapyCancer
2021
LBA25 Final overall survival (OS) analysis from ARCHES: A phase III, randomized, double-blind, placebo (PBO)-controlled study of enzalutamide (ENZA) + androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC)
Armstrong A, Iguchi T, Azad A, Szmulewitz R, Holzbeierlein J, Villers A, Alcaraz A, Alekseev B, Shore N, Petrylak D, Rosbrook B, Zohren F, Yamada S, Haas G, Stenzl A. LBA25 Final overall survival (OS) analysis from ARCHES: A phase III, randomized, double-blind, placebo (PBO)-controlled study of enzalutamide (ENZA) + androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC). Annals Of Oncology 2021, 32: s1300-s1301. DOI: 10.1016/j.annonc.2021.08.2101.Peer-Reviewed Original ResearchThe efficacy of enzalutamide (ENZA) plus androgen deprivation therapy (ADT) on bone oligometastatic hormone-sensitive prostate cancer: A post hoc analysis of ARCHES.
Armstrong A, Iguchi T, Azad A, Villers A, Alekseev B, Petrylak D, Szmulewitz R, Alcaraz A, Shore N, Holzbeierlein J, Gomez-Veiga F, Rosbrook B, Zohren F, Haas G, Gourgioti G, El-Chaar N, Stenzl A. The efficacy of enzalutamide (ENZA) plus androgen deprivation therapy (ADT) on bone oligometastatic hormone-sensitive prostate cancer: A post hoc analysis of ARCHES. Journal Of Clinical Oncology 2021, 39: 5071-5071. DOI: 10.1200/jco.2021.39.15_suppl.5071.Peer-Reviewed Original ResearchMetastatic hormone-sensitive prostate cancerAndrogen deprivation therapyEfficacy of enzalutamideHormone-sensitive prostate cancerBone metastasesTreatment armsProstate cancerOligometastatic hormone-sensitive prostate cancerPrior docetaxel chemotherapySecondary clinical outcomesDeprivation therapyEfficacy outcomesRadiographic progressionSecondary endpointsBaseline characteristicsDisease volumeDocetaxel chemotherapyMetastatic burdenPolymetastatic diseaseArch studyClinical outcomesCentral reviewClinical benefitSafety profilePlaceboEfficacy of enzalutamide (ENZA) plus androgen deprivation therapy (ADT) in men with de novo (M1) metastatic hormone-sensitive prostate cancer (mHSPC) versus progression to mHSPC (M0): Post hoc analysis of the phase III ARCHES trial.
Azad A, Villers A, Alekseev B, Szmulewitz R, Alcaraz A, Shore N, Petrylak D, Holzbeierlein J, Gomez-Veiga F, Rosbrook B, Zohren F, Lee H, Haas G, Iguchi T, Stenzl A, Armstrong A. Efficacy of enzalutamide (ENZA) plus androgen deprivation therapy (ADT) in men with de novo (M1) metastatic hormone-sensitive prostate cancer (mHSPC) versus progression to mHSPC (M0): Post hoc analysis of the phase III ARCHES trial. Journal Of Clinical Oncology 2021, 39: 102-102. DOI: 10.1200/jco.2021.39.6_suppl.102.Peer-Reviewed Original ResearchMetastatic hormone-sensitive prostate cancerEfficacy of enzalutamideAndrogen deprivation therapyDe novo metastatic hormone-sensitive prostate cancerM1 diseaseInitial diagnosisProstate-specific antigenSecondary endpointsDisease volumeTreatment armsHormone-sensitive prostate cancerProgression-free survival eventsPrior docetaxel useKey secondary endpointNew antineoplastic therapiesDeprivation therapyDocetaxel usePrior docetaxelEfficacy outcomesPrimary endpointPSA progressionBaseline characteristicsObjective responseClinical benefitSafety profileCheckMate 9KD Arm B final analysis: Efficacy and safety of nivolumab plus docetaxel for chemotherapy-naïve metastatic castration-resistant prostate cancer.
Fizazi K, González Mella P, Castellano D, Minatta J, Rezazadeh A, Shaffer D, Vazquez Limon J, Sánchez López H, Armstrong A, Horvath L, Dzik C, Amin N, Li J, Unsal-Kacmaz K, Retz M, Saad F, Petrylak D, Pachynski R. CheckMate 9KD Arm B final analysis: Efficacy and safety of nivolumab plus docetaxel for chemotherapy-naïve metastatic castration-resistant prostate cancer. Journal Of Clinical Oncology 2021, 39: 12-12. DOI: 10.1200/jco.2021.39.6_suppl.12.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerTreatment-related AEsObjective response rateChemotherapy-naïve metastatic castration-resistant prostate cancerRadiographic progression-free survivalCastration-resistant prostate cancerMeasurable diseaseOverall survivalArm BProstate cancerMedian numberChemotherapy-naive metastatic castration-resistant prostate cancerDisease progression/unacceptable toxicityProstate-specific antigen (PSA) response rateResponse rateComparable objective response rateOngoing androgen deprivation therapyProgression/unacceptable toxicityImmune-related AESafety of nivolumabTreatment-related deathsAndrogen deprivation therapyPhase 2 trialProgression-free survivalAntitumor immune responseBXCL701, first-in-class oral activator of systemic innate immunity pathway, combined with pembrolizumab (Keytruda) in men with metastatic castration-resistant prostate cancer (mCRPC).
Aggarwal R, Costin D, Zhang J, Karsh L, Healey D, Linch M, Adurthi S, Petrylak D, O'Neill V, Monk P. BXCL701, first-in-class oral activator of systemic innate immunity pathway, combined with pembrolizumab (Keytruda) in men with metastatic castration-resistant prostate cancer (mCRPC). Journal Of Clinical Oncology 2021, 39: 124-124. DOI: 10.1200/jco.2021.39.6_suppl.124.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerTotal daily doseAdverse eventsPhase 2 portionObjective responseImproved tolerabilityAnti-PD-1/PD-L1Day 1Serum IL-18 levelsCastration-resistant prostate cancerOral small-molecule inhibitorDipeptidyl peptidasePreliminary anti-tumor activityPhase 2 doseAndrogen deprivation therapyCytokine release syndromeStage IV melanomaIL-18 levelsPD-L1 expressionSignificant tumor growth inhibitionLower extremity edemaImmune effector cellsPrior clinical studiesTarget adverse eventsProstate cancer phenotype
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 pointARCHES - The role of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (mHSPC): Post hoc analyses of efficacy by baseline prostate-specific antigen (PSA) levels
Alcaraz A, Szmulewitz R, Shore N, Crawford E, Petrylak D, Holzbeierlein J, Villers A, Azad A, Alekseev B, Iguchi T, Gomez-Veiga F, Rosbrook B, Sugg J, Haas G, Stenzl A, Armstrong A. ARCHES - The role of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (mHSPC): Post hoc analyses of efficacy by baseline prostate-specific antigen (PSA) levels. Annals Of Oncology 2020, 31: s523-s524. DOI: 10.1016/j.annonc.2020.08.894.Peer-Reviewed Original Research557 ARCHES: Efficacy of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (mHSPC) by prior local and systemic treatment
Stenzl A, Szmulewitz R, Petrylak D, Holzbeierlein J, Villers A, Azad A, Alcaraz A, Alekseev B, Iguchi T, Shore N, Gomez-Veiga F, Rosbrook B, Baron B, Haas G, Armstrong A. 557 ARCHES: Efficacy of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (mHSPC) by prior local and systemic treatment. European Urology Open Science 2020, 19: e865-e866. DOI: 10.1016/s2666-1683(20)33160-8.Peer-Reviewed Original ResearchEfficacy of enzalutamide (ENZA) + androgen deprivation therapy (ADT) in metastatic hormone-sensitive prostate cancer (mHSPC) by pattern of metastatic spread: ARCHES post hoc analyses.
Shore N, Armstrong A, Szmulewitz R, Petrylak D, Holzbeierlein J, Villers A, Azad A, Alcaraz A, Alekseev B, Iguchi T, Gomez-Veiga F, Rosbrook B, Lee H, Haas G, Stenzl A. Efficacy of enzalutamide (ENZA) + androgen deprivation therapy (ADT) in metastatic hormone-sensitive prostate cancer (mHSPC) by pattern of metastatic spread: ARCHES post hoc analyses. Journal Of Clinical Oncology 2020, 38: 5547-5547. DOI: 10.1200/jco.2020.38.15_suppl.5547.Peer-Reviewed Original ResearchRadiographic progression-free survivalEfficacy of enzalutamideAndrogen deprivation therapyMetastatic hormone-sensitive prostate cancerSymptomatic skeletal eventsSoft tissue metastasesMetastatic spreadVisceral metastasesSecondary endpointsBone metastasesFirst symptomatic skeletal eventHormone-sensitive prostate cancerProstate-specific antigen progressionLarge patient subgroupPrior docetaxel treatmentProgression-free survivalSecondary endpoint measuresGreater relative efficacyNew antineoplastic therapiesM0 patientsDeprivation therapyPrimary endpointSkeletal eventsCastration resistanceDisease volumePD10-10 IMPACT OF BASELINE DISEASE VOLUME AND PRIOR DOCETAXEL THERAPY ON PROSTATE-SPECIFIC ANTIGEN-RELATED OUTCOMES IN PATIENTS WITH METASTATIC HORMONE-SENSITIVE PROSTATE CANCER TREATED WITH ENZALUTAMIDE PLUS ANDROGEN DEPRIVATION THERAPY
Shore* N, Crawford E, Szmulewitz R, Petrylak D, Holzbeierlein J, Villers A, Azad A, Alcaraz A, Alekseev B, Iguchi T, Gomez-Veiga F, Rosbrook B, Baron B, Haas G, Stenzl A, Armstrong A. PD10-10 IMPACT OF BASELINE DISEASE VOLUME AND PRIOR DOCETAXEL THERAPY ON PROSTATE-SPECIFIC ANTIGEN-RELATED OUTCOMES IN PATIENTS WITH METASTATIC HORMONE-SENSITIVE PROSTATE CANCER TREATED WITH ENZALUTAMIDE PLUS ANDROGEN DEPRIVATION THERAPY. Journal Of Urology 2020, 203 DOI: 10.1097/ju.0000000000000844.010.Peer-Reviewed Original ResearchPhase 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
LBA52 Efficacy and safety of nivolumab in combination with docetaxel in men with metastatic castration-resistant prostate cancer in CheckMate 9KD
Fizazi K, Mella P, Castellano D, Minatta J, Kalebasty A, Shaffer D, Limon J, Armstrong A, Lopez H, Sharkey B, Saci A, Li J, Wang X, Ciprotti M, Sathyanarayana P, Saad F, Petrylak D, Retz M, Pachynski R, Drake C. LBA52 Efficacy and safety of nivolumab in combination with docetaxel in men with metastatic castration-resistant prostate cancer in CheckMate 9KD. Annals Of Oncology 2019, 30: v885-v886. DOI: 10.1093/annonc/mdz394.045.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerRadiographic progression-free survivalObjective response rateCastration-resistant prostate cancerBristol-Myers SquibbGenentech/RocheAssociation of biomarkersPersonal feesMeasurable diseaseProstate cancerGrade 3/4 treatment-related adverse eventsMedian radiographic progression-free survivalProstate-specific antigen (PSA) response rateResponse rateOngoing androgen deprivation therapyTreatment-related adverse eventsSafety of nivolumabAndrogen deprivation therapyPhase II studyPhase III trialsProgression-free survivalSanofi-AventisInterim analysis resultsMedical writing assistanceNon-financial support853P ARCHES - The role of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (mHSPC): Post hoc analyses of high and low disease volume and risk groups
Stenzl A, Szmulewitz R, Petrylak D, Holzbeierlein J, Villers A, Azad A, Alcaraz A, Alekseev B, Iguchi T, Shore N, Rosbrook B, Baron B, Haas G, Morlock R, Ramaswamy K, Armstrong A. 853P ARCHES - The role of androgen deprivation therapy (ADT) with enzalutamide (ENZA) or placebo (PBO) in metastatic hormone-sensitive prostate cancer (mHSPC): Post hoc analyses of high and low disease volume and risk groups. Annals Of Oncology 2019, 30: v332-v333. DOI: 10.1093/annonc/mdz248.010.Peer-Reviewed Original ResearchRadiographic progression-free survivalAndrogen deprivation therapyMetastatic hormone-sensitive prostate cancerCastration-resistant prostate cancerSymptomatic skeletal eventsProgression-free survivalDisease volumeOverall survivalRisk groupsAdverse eventsQuality of lifeAstellas PharmaBristol-Myers SquibbDeprivation therapyVisceral metastasesSkeletal eventsRadiographic responseTrial criteriaBone lesionsProstate cancerHigher QoLHormone-sensitive prostate cancerProstate-specific antigen progressionAstellas Pharma Inc.Genentech/Roche891TiP 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