Abiraterone and Olaparib for Metastatic Castration-Resistant Prostate Cancer

Clarke, Noel W.; Armstrong, Andrew J.; Thiery-Vuillemin, Antoine; Oya, Mototsugu; Shore, Neal; Loredo, Eugenia; Procopio, Giuseppe; de Menezes, Juliana; Girotto, Gustavo; Arslan, Cagatay; Mehra, Niven; Parnis, Francis; Brown, Emma; Schlürmann, Friederike; Joung, Jae Y.; Sugimoto, Mikio; Virizuela, Juan A.; Emmenegger, Urban; Navratil, Jiri; Buchschacher, Gary L.; Poehlein, Christian; Harrington, Elizabeth A.; Desai, Chintu; Kang, Jinyu; Saad, Fred

doi:10.1056/evidoa2200043

Cited by 430Prostate Cancer Treatment and ResearchPARP inhibition in cancer therapyAdvanced Breast Cancer Therapies

Abiraterone and Olaparib for Metastatic Castration-Resistant Prostate Cancer

Clarke, Noel W., Armstrong, Andrew J., Thiery-Vuillemin, Antoine, Oya, Mototsugu, Shore, Neal, Loredo, Eugenia, Procopio, Giuseppe, de Menezes, Juliana +17 more·2022·NEJM Evidence

DOI 10.1056/evidoa2200043

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Abstract

BACKGROUND: Preclinical studies and results of a phase 2 trial of abiraterone and olaparib suggest a combined antitumor effect when the poly(adenosine diphosphate[ADP]-ribose) polymerase inhibitor olaparib is combined with next-generation hormonal agent abiraterone to treat metastatic castration-resistant prostate cancer (mCRPC). METHODS: We conducted a double-blind, phase 3 trial of abiraterone and olaparib versus abiraterone and placebo in patients with mCRPC in the first-line setting. Patients were enrolled regardless of homologous recombination repair gene mutation (HRRm) status. HRRm status was determined following enrollment by tumor tissue and circulating tumor DNA tests. Patients were randomly assigned (1:1) to receive abiraterone (1000 mg once daily) plus prednisone or prednisolone with either olaparib (300 mg twice daily) or placebo. The primary end point was imaging-based progression-free survival (ibPFS) by investigator assessment. Overall survival was among the secondary end points. RESULTS: At this planned primary analysis at the first data cutoff, median ibPFS was significantly longer in the abiraterone and olaparib arm than in the abiraterone and placebo arm (24.8 vs. 16.6 months; hazard ratio, 0.66; 95% confidence interval [CI], 0.54 to 0.81; P<0.001) and was consistent with blinded independent central review (hazard ratio, 0.61; 95% CI, 0.49 to 0.74). At this data cutoff, overall survival data were immature (28.6% maturity; hazard ratio, 0.86; 95% CI, 0.66 to 1.12; P=0.29). The safety profile of olaparib and abiraterone was consistent with the known safety profiles of the individual drugs. The most common adverse events in the abiraterone and olaparib arm were anemia, fatigue/asthenia, and nausea. CONCLUSIONS: At primary analysis at this first data cutoff, abiraterone combined with olaparib significantly prolonged ibPFS compared with abiraterone and placebo as first-line treatment for patients with mCRPC enrolled irrespective of HRRm status. (Funded by AstraZeneca and Merck Sharp & Dohme, LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA; ClinicalTrials.gov number, NCT03732820.)

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In the phase 3 PROpel trial, the combination of abiraterone plus olaparib as first-line treatment resulted in improved PFS compared with abiraterone plus placebo (median: 24.8 vs 16.6 months; HR 0.66; 95% CI 0.54-0.81; p < 0.001) irrespective of HRR status.
“In the phase 3 PROpel trial (NCT03732820), the combination of abiraterone plus olaparib as first-line treatment resulted in improved PFS compared with abiraterone plus placebo (median: 24.8 vs 16.6 months; HR 0.66; 95% CI 0.54–0.81; p < 0.001) irrespective of HRR status [60].”
From Navigating therapeutic sequencing in the metastatic castration-resistant prostate cancer patient journey (2025) · cites this paper as [60]
Patients with mCRPC who developed resistance on a prior ARPI were not represented in PROpel, MAGNITUDE, or TALAPRO-2, so the benefit of these combinations in these patients is not known.
“Of note, patients with mCRPC who developed resistance on a prior ARPI were not represented in PROpel, MAGNITUDE, or TALAPRO-2, so the benefit of these combinations in these patients is not known [28, 60, 63].”
From Navigating therapeutic sequencing in the metastatic castration-resistant prostate cancer patient journey (2025) · cites this paper as [60]
In a post hoc exploratory analysis of PROpel, the radiographic PFS benefit of olaparib plus abiraterone was most pronounced in the HRR-mutated (HR 0.50; 95% CI 0.34-0.73) and BRCAm subgroups (HR 0.23; 95% CI 0.12-0.43).
“In a post hoc exploratory analysis, the radiographic PFS (rPFS) benefit of olaparib plus abiraterone was most pronounced in the HRR-mutated (HRRm) (HR 0.50; 95% CI 0.34–0.73) and BRCAm subgroups (HR 0.23; 95% CI 0.12–0.43) [60, 61].”
From Navigating therapeutic sequencing in the metastatic castration-resistant prostate cancer patient journey (2025) · cites this paper as [60]

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Evaluation of Efficacy and Safety of Olaparib in Combination With Abiraterone for the Treatment of Metastatic Castration-Resistant Prostate Cancer (mCRPC) With Homologous Recombination Repair Gene Mutations
Wang, Y., & Zhan, P. (2026) · Clinical Genitourinary Cancer · doi:10.1016/j.clgc.2026.102588
Olaparib combined with abiraterone in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): A randomized phase II trial.
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Self-citation
Olaparib combined with abiraterone in patients with metastatic castration-resistant prostate cancer: a randomised, double-blind, placebo-controlled, phase 2 trial
Clarke, N. W., Wiechno, P., Alekseev, B. Y., Sala, N., Jones, R., Kocák, I., Chiurì, V. E., Jassem, J., Fléchon, A., Redfern, C. H., et al. (2018) · The Lancet Oncology · doi:10.1016/s1470-2045(18)30365-6 · Cited by 397 · see citing works
Self-citation
OLAPARIB IN COMBINATION WITH ABIRATERONE IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER: A SYSTEMATIC REVIEW
Macedo, R. M., & de Carvalho, K. C. N. (2025) · CIPEEX
Olaparib combined with abiraterone in HRR-mutated metastatic hormone-sensitive prostate cancer: a single-arm phase II trial
Zhang, X., Wu, Z., Hao, L., Qiu, X., Xu, L., Zhang, S., Guo, H., & Zhuang, J. (2026) · World Journal of Urology · doi:10.1007/s00345-026-06460-8 · Cited by 1 · see citing works

Authors: Clarke, N. W., Armstrong, A. J., Thiery-Vuillemin, A., Oya, M., Shore, N., Loredo, E., Procopio, G., de Menezes, J., Girotto, G., Arslan, C., Mehra, N., Parnis, F., Brown, E., Schlürmann, F., Joung, J. Y., Sugimoto, M., Virizuela, J. A., Emmenegger, U., Navratil, J., Buchschacher, G. L., Poehlein, C., Harrington, E. A., Desai, C., Kang, J., & Saad, F.
Affiliations: University of Manchester (GB)
Duke University (US)
Centre Hospitalier Universitaire de Besançon (FR)
Keio University (JP)
Carolina Urologic Research Center (US)
Centro de Investigaciones Clinicas Viña del Mar, Valparaíso, Chile
Fondazione IRCCS Istituto Nazionale dei Tumori (IT)
Hospital Nossa Senhora da Conceição, Porte Alegre, Brazil
Hospital de Base (BR)
Izmir Economy University Medical Park Hospital, Karsiyaka, Turkey
Radboud University Medical Center (NL)
Ashford Cancer Centre Research, Adelaide, South Australia
University Hospital Southampton NHS Foundation Trust (GB)
Centre Hospitalier de Cornouaille (FR)
National Cancer Center (KR)
Kagawa University Hospital (JP)
Hospital Universitario Virgen Macarena (ES)
Sunnybrook Research Institute (CA)
Masaryk Memorial Cancer Institute, Brno, Czech Republic
Kaiser Permanente (US)
Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
AstraZeneca (United Kingdom) (GB)
AstraZeneca (United States) (US)
Centre Hospitalier de l’Universite de Montreal, Montreal
ORCID: Clarke, Noel W.
Armstrong, Andrew J.
Thiery-Vuillemin, Antoine
Oya, Mototsugu
Shore, Neal
Procopio, Giuseppe
Girotto, Gustavo
Mehra, Niven
Joung, Jae Y.
Sugimoto, Mikio
Virizuela, Juan A.
Emmenegger, Urban
Buchschacher, Gary L.
Poehlein, Christian
Harrington, Elizabeth A.
Kang, Jinyu
Venue: NEJM Evidence
Publisher: Massachusetts Medical Society
Published: 2022-08-23
Volume: 1
Issue: 9
Pages: EVIDoa2200043-EVIDoa2200043
ISSN: 2766-5526 (ISSN-L)
DOI: 10.1056/evidoa2200043
OpenAlex: W4281770555
Cited by: 426
References: 27
Citations by year: 2026: 77 · 2025: 108 · 2024: 111 · 2023: 110 · 2022: 20
FWCI: 56.30
Type: journal article
Language: en
Open access: closed
Locations: NEJM Evidence (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Treatment and Research
Health Sciences › Medicine › Oncology › PARP inhibition in cancer therapy
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Advanced Breast Cancer Therapies
Keywords: abiraterone, olaparib, metastatic castration-resistant prostate cancer, PARP inhibitors, first-line therapy, homologous recombination deficiency, progression-free survival, overall survival, combination therapy, PARP inhibitor resistance, circulating tumor DNA, anemia, fatigue, nausea, hormone therapy
MeSH terms: Androstenes, Antineoplastic Combined Chemotherapy Protocols, Humans, Male, Phthalazines, Piperazines, Prostatic Neoplasms, Castration-Resistant

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Abiraterone and Olaparib for Metastatic Castration-Resistant Prostate Cancer

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