A phase III randomized, placebo-controlled, double-blind study of niraparib plus abiraterone acetate and prednisone versus abiraterone acetate and prednisone in patients with metastatic prostate cancer (MAGNITUDE).

Kim N Chi; Dana E Rathkopf; Gerhardt Attard; Matthew Raymond Smith; Eleni Efstathiou; David Olmos; Eric Jay Small; Ji Youl Lee; Deborah S Ricci; Jason S Simon; Xin Zhao; Nishi Kothari; Shinta Cheng; Shahneen Kaur Sandhu

Conference Proceedings

A phase III randomized, placebo-controlled, double-blind study of niraparib plus abiraterone acetate and prednisone versus abiraterone acetate and prednisone in patients with metastatic prostate cancer (MAGNITUDE).

Kim N Chi, Dana E Rathkopf, Gerhardt Attard, Matthew Raymond Smith, Eleni Efstathiou, David Olmos, Eric Jay Small, Ji Youl Lee, Deborah S Ricci, Jason S Simon, Xin Zhao, Nishi Kothari, Shinta Cheng, Shahneen Kaur Sandhu

JOURNAL OF CLINICAL ONCOLOGY | LIPPINCOTT WILLIAMS & WILKINS | Published : 2020

DOI: 10.1200/jco.2020.38.15_suppl.tps5588

Abstract

TPS5588 Background: Preclinical data suggest synergistic antitumor activity when the PARP inhibitor (PARPi) niraparib is combined with the androgen pathway inhibitor abiraterone acetate1. The addition of a PARPi to abiraterone acetate plus prednisone (AAP) showed improved radiographic progression-free survival (rPFS) vs AAP alone in patients with mCRPC regardless of DNA repair gene defect (DRD) status2. Interim results from a phase I study support safety and tolerability of niraparib 200 mg combined with AAP in patients with mCRPC3. The objective of this Phase III study is to compare the efficacy and safety of niraparib plus AAP versus AAP with placebo as first-line therapy for mCRPC. Metho..

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