KEYNOTE-921: Phase III study of pembrolizumab plus docetaxel for metastatic castration-resistant prostate cancer.

Despite recent advances, treatment options for men with metastatic castration-resistant prostate cancer (mCRPC) progressing after next-generation hormonal agents (NHAs) are limited and provide only modest survival benefit. Thus, an unmet need remains for mCRPC patients after treatment with targeted endocrine therapy or NHA therapy. Pembrolizumab, a humanized monoclonal antibody for PD-1, has been found to have activity as monotherapy in patients with mCRPC and as combination therapy in a Phase Ib/II study with docetaxel and prednisone/prednisolone for patients previously treated with enzalutamide or abiraterone acetate. The aim of the randomized, double-blind, Phase III KEYNOTE-921 study is to evaluate the efficacy and safety of pembrolizumab plus docetaxel in patients with mCRPC who were previously treated with an NHA. Clinical trial registration: NCT03834506 (ClinicalTrials.gov).

Future oncology (London, England). 2021 Jun 08 [Epub ahead of print]

Daniel P Petrylak, Raffaele Ratta, Rustem Gafanov, Gaetano Facchini, Josep M Piulats, Gero Kramer, Thomas W Flaig, Sreenivasa R Chandana, Ben Li, Joseph Burgents, Karim Fizazi

Department of Internal Medicine, Smilow Cancer Hospital, Yale School of Medicine, New Haven, CT 06511, USA., Department of Medical Oncology, Foch Hospital, Suresnes, 92151, France., Department of Oncourology, Russian Scientific Center of Roentgen Radiology, Moscow, 117997, Russia., Departmental Unit of Experimental Uro-Androlo, Istituto Nazionale Tumori IRCCS, Fondazione G. Pascale, Naples, 80131, Italy., Department of Medical Oncology, Catalan Institute of Oncology, Barcelona, 08908, Spain., Department of Urology, Medical University of Vienna, Vienna, 1090, Austria., Department of Medicine, University of Colorado School of Medicine, Aurora, CO 80045, USA., Department of Medical Oncology, Cancer & Hematology Centers of Western Michigan, Grand Rapids, MI 49503, USA., Department of Clinical Research, Merck & Co., Inc., Kenilworth, NJ 07033, USA., Department of Cancer Medicine, Institut Gustave Roussy and University of Paris Saclay, Villejuif, 94800, France.