In the phase 3 PROpel trial (NCT03732820) patients with metastatic castration-resistant prostate cancer (mCRPC) treated with olaparib plus abiraterone in the first-line setting showed significantly prolonged radiographic progression-free survival (rPFS; primary data cutoff [DCO]: 30 July 2021; hazard ratio [HR] 0. 66, 95% confidence interval [CI], 0.54-0.81; p < 0.001), and at prespecified final OS analysis DCO (12 October 2022) numerically prolonged overall survival (OS; HR 0.81, 95% CI, 0.67-1.00; p = 0.054), versus placebo plus abiraterone for the global population. Here, we report efficacy, safety, and patient-reported outcome data for the Asian subset in PROpel. Eligible patients were randomly assigned (1:1) to either olaparib (300 mg twice daily) or placebo in combination with abiraterone (1000 mg once daily). The primary endpoint was investigator-assessed rPFS, and a key secondary endpoint was OS. In the Asian subset (n = 133) at primary analysis, median rPFS was 27.6 months in the olaparib plus abiraterone arm (n = 63), compared with 19.3 months in the placebo plus abiraterone arm (n = 70; HR 0.55, 95% CI, 0.32-0.95). Median OS at the final analysis was not reached in the olaparib plus abiraterone arm versus 43.7 months in the placebo plus abiraterone arm (HR 0.59, 95% CI, 0.32-1.06). The safety profile was generally similar in the Asian subset and the global population. Efficacy and safety results for olaparib plus abiraterone in the Asian subset were generally consistent with the global PROpel population supporting the combination of olaparib plus abiraterone as an important first-line treatment for consideration in Asian patients with mCRPC. Trial Registration: Clinicaltrials.gov identifier: NCT03732820.
Cancer science. 2025 Mar 18 [Epub ahead of print]
Mototsugu Oya, Jae Young Joung, Ji Youl Lee, Mikio Sugimoto, Young Deuk Choi, Jun Hyuk Hong, Hiroji Uemura, Kazuo Nishimura, Hideyasu Tsumura, Satoru Kawakami, Yukiyoshi Hirayama, Tae Gyun Kwon, Cheol Kwak, Hiroyoshi Suzuki, Tomoko Fujita, Masahiro Nii, David McGuinness, Melanie Dujka, Christian Poehlein, Fred Saad, Noel Clarke
Keio University Hospital, Tokyo, Japan., Center for Prostate Cancer, National Cancer Center, Goyang, South Korea., Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, South Korea., Kagawa University Hospital, Kagawa, Japan., Yonsei University College of Medicine, Seoul, South Korea., Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea., Yokohama City University Medical Center, Yokohama, Japan., Osaka International Cancer Institute, Osaka, Japan., Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan., Saitama Medical Center, Saitama Medical University, Kawagoe, Japan., Osaka Metropolitan University Graduate School of Medicine, Osaka, Japan., Chilgok Kyungpook National University Medical Center, Daegu, South Korea., Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea., Toho University Sakura Medical Center, Chiba, Japan., AstraZeneca, Osaka, Japan., AstraZeneca, Cambridge, UK., AstraZeneca, Gaithersburg, Maryland, USA., Merck & Co. Inc., Rahway, New Jersey, USA., Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada., The Christie and Salford Royal Hospital NHS Foundation Trusts and University of Manchester, Manchester, UK.