Pembrolizumab plus enzalutamide and androgen deprivation therapy versus placebo plus enzalutamide and androgen deprivation therapy for metastatic hormone-sensitive prostate cancer: the randomized, double-blind, phase III KEYNOTE-991 study
KEYNOTE-991 did not meet its primary endpoint and was stopped for futility. The addition of pembrolizumab to enzalutamide and ADT was associated with higher frequencies of grade ≥3 AEs and SAEs than with placebo. Rash was identified as an additional safety signal with pembrolizumab plus enzalutamide and ADT.
Authors
- Margitta Retz
- Christian Gratzke (ORCID: https://orcid.org/0000-0003-4070-0952)
- Christian Poehlein (ORCID: https://orcid.org/0000-0002-3348-3059)
- Jeffrey C. Goh (ORCID: https://orcid.org/0000-0003-3103-146X)
- Josep M. Piulats (ORCID: https://orcid.org/0000-0002-3606-1724)
- Gautam Jayram
- Mustafa Özgüroğlu (ORCID: https://orcid.org/0000-0002-8417-8628)
- JC Penagos
- A. Peer (ORCID: https://orcid.org/0009-0000-3661-2496)
- Juan Carlos Vázquez Limón
- Mehmet Alı Nahıt Şendur (ORCID: https://orcid.org/0000-0001-7021-6139)
- Ray Manneh Kopp (ORCID: https://orcid.org/0000-0002-8106-9741)
- Cheol Kwak (ORCID: https://orcid.org/0000-0002-1987-2111)
- Chen Niu (ORCID: https://orcid.org/0000-0001-7619-2043)
- Ugo De Giorgi (ORCID: https://orcid.org/0000-0001-7520-2908)
- Karine Martins da Trindade (ORCID: https://orcid.org/0009-0006-4947-0304)
- Wolfgang Loidl (ORCID: https://orcid.org/0000-0001-9354-5728)
- Yang Liu (ORCID: https://orcid.org/0000-0002-2883-8329)
- Mariusz Kwiatkowski
- Seok‐Soo Byun
Institutions
- Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
- University Medical Center Freiburg (DE)
- Rambam Health Care Campus (IL)
- TUM Klinikum (DE)
- Seoul National University Hospital (KR)
- Seoul National University Bundang Hospital (KR)
- Popular University of Cesar (CO)
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IT)
- Urology Associates (US)
- D’Or Institute for Research and Education (BR)
- Institut Català d'Oncologia (ES)
- Istanbul University-Cerrahpaşa (TR)
- Hospital Civil de Guadalajara (MX)
- Gallipoli Medical Research Foundation (AU)
- Krankenhaus der Elisabethinen (AT)
- Wojewódzki Szpital Zespolony (PL)
- Ankara Yıldırım Beyazıt University (TR)
- Universidad Valle del Grijalva (MX)
- Istituti di Ricovero e Cura a Carattere Scientifico (IT)
Publication Details
- Journal
- Annals of Oncology
- Published
- 2025-05-16
- DOI
- https://doi.org/10.1016/j.annonc.2025.05.008
- Citations
- 4
- Primary Topic
- Prostate Cancer Treatment and Research
- Type
- article
- Field-Weighted Citation Impact
- 6.07