PROpel: Phase III trial of olaparib (ola) and abiraterone (abi) versus placebo (pbo) and abi as first-line (1L) therapy for patients (pts) with metastatic castration-resistant prostate cancer (mCRPC)

Autor: Fred Saad, Andrew J. Armstrong, Antoine Thiery-Vuillemin, Mototsugu Oya, Eugenia Loredo, Giuseppe Procopio, Juliana Janoski de Menezes, Gustavo Colagiovanni Girotto, Cagatay Arslan, Niven Mehra, Francis Parnis, Emma Brown, Friederike Schlürmann, Jae Young Joung, Mikio Sugimoto, Christian Heinrich Poehlein, Elizabeth Harrington, Chintu Desai, Jinyu Kang, Noel Clarke
Rok vydání: 2022
Předmět:
Zdroj: Journal of Clinical Oncology. 40:11-11
ISSN: 1527-7755
0732-183X
Popis: 11 Background: Preclinical studies have shown combined anti-tumor effect through interactions between poly(adenosine diphosphate–ribose) polymerase and androgen receptor signaling pathways. A Phase II trial (NCT01972217) in pts with mCRPC unselected by homologous recombination repair (HRR) status who previously received docetaxel demonstrated improved radiographic progression-free survival (rPFS) for pts treated with ola + abi vs pbo + abi (Clarke N, 2018). The Phase III PROpel study (NCT03732820) evaluates the efficacy and safety of ola + abi in the 1L mCRPC setting. Methods: PROpel is a randomized, double-blind, placebo-controlled Phase III trial in pts with mCRPC undergoing 1L treatment after failure of primary androgen deprivation therapy, enrolled independent of HRR status. Pts were randomized 1:1 to receive ola (300 mg twice daily [bid]) or pbo, and abi (1000 mg once daily) + prednisone or prednisolone (5 mg bid). The primary endpoint was investigator-assessed rPFS with multiple secondary endpoints, including overall survival (OS). Results:796 pts were randomized to ola + abi (n=399) or pbo + abi (n=397).In this planned interim analysis, 1L treatment with ola + abi significantly prolonged rPFS vs pbo + abi in pts with mCRPC irrespective of HRR status (24.8 vs 16.6 months; hazard ratio [HR] 0.66, 95% confidence interval [CI] 0.54–0.81; P
Databáze: OpenAIRE
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