Olaparib Plus Abiraterone in Asian Patients With Metastatic Castration‐Resistant Prostate Cancer: <scp>PROpel</scp> Subset Analysis

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.

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Publication Details

Journal
Cancer Science
Published
2025-03-18
DOI
https://doi.org/10.1111/cas.16459
Primary Topic
Prostate Cancer Treatment and Research
Type
article
Field-Weighted Citation Impact
0.00

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article

Olaparib Plus Abiraterone in Asian Patients With Metastatic Castration‐Resistant Prostate Cancer: PROpel Subset Analysis

Tae Gyun Kwon, Yukiyoshi Hirayama, Jae Young Joung, Christian Poehlein et al.
1 links
Cancer Science
Prostate Cancer Treatment and Research
article

Olaparib Plus Abiraterone in Asian Patients With Metastatic Castration‐Resistant Prostate Cancer: PROpel Subset Analysis

Tae Gyun Kwon, Yukiyoshi Hirayama, Jae Young Joung, Christian Poehlein, David McGuinness, Satoru Kawakami, Melanie Dujka, Jun Hyuk Hong, Fred Saad, Cheol Kwak, Ji Youl Lee, Noel W. Clarke, Hideyasu Tsumura, Kazuo Nishimura, Mikio Sugimoto, Hiroji Uemura, Mototsugu Oya, Tomoko Fujita, Young Deuk Choi, Hiroyoshi Suzuki, Masahiro Nii
article en

Abstract

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 ScienceVol. 116(6)
AstraZeneca (United Kingdom) (GB), Ulsan College (KR), Merck & Co., Inc., Rahway, NJ, USA (United States) (US), Toho University (JP), Yonsei University (KR), Salford Royal NHS Foundation Trust (GB), Asan Medical Center (KR), Yokohama City University Medical Center (JP), Seoul National University Hospital (KR), University of Ulsan (KR), Kyungpook National University Medical Center (KR), Keio University Hospital (JP), Salford Royal Hospital (GB), National Cancer Center (KR), Toho University Medical Center Sakura Hospital (JP), AstraZeneca (Japan) (JP), Kagawa University Hospital (JP), Centre Hospitalier de l’Université de Montréal (CA), AstraZeneca (United States) (US), Osaka International Cancer Institute (JP), Social Insurance Saitama Chuo Hospital (JP), The Catholic University of Korea Seoul St. Mary's Hospital (KR), Osaka Metropolitan University (JP), Kitasato University (JP), Tokyo Metropolitan University (JP), Saitama Medical University (JP), Catholic University of Korea (KR), Yokohama City University (JP)
AstraZeneca
Good health and well-being
Openalex Percentile: Top 93%
Prostate Cancer Treatment and Research
DOIOpen Access PDFOpenAlex
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