CHICAGO — Neeraj Agarwal, MD, professor of medicine and director of the genitourinary oncology program at The University of Utah’s Huntsman Cancer Institute, presented early safety results of the TALAPRO-2 trial at ASCO Annual Meeting.
The randomized phase 3 study is designed to evaluate the efficacy and safety of the addition of the PARP inhibitor talazoparib (Talzenna, Pfizer) to standard-of-care enzalutamide (Xtandi; Astellas, Pfizer), a potent androgen receptor inhibitor, for men with newly diagnosed metastatic castration-resistant prostate cancer.
In part one of the trial, researchers aimed to identify the appropriate starting dose of the combination based on safety and pharmacokinetic evaluation.
Results showed talazoparib 0.5 mg daily plus enzalutamide 160 mg daily exhibited a manageable safety profile, and that will be the starting dose for the randomized portion of TALAPRO-2.
Radiographic PFS and OS will serve as primary endpoints. – by Mark Leiser
Reference: Aggarwal N, et al. Abstract 5076. Presented at: ASCO Annual Meeting; May 31-June 4, 2019; Chicago.
Disclosure: Agarwal reports consultant/advisory roles with AstraZeneca, Bayer, Bristol-Myers Squibb, Clovis Oncology, Eisai, Eli Lilly, EMD Serono, Exelixis, Foundation One, Genentech/Roche, Medivation/Astellas, Merc, Nektar, Novartis, Pfizer and Pharmacyclics. He also reports research funding to his institution from Active Biotech, Amgen, AstraZeneca, Bavarian Nordic, Bayer, BN ImmunoTherapeutics, Bristol-Myers Squibb, Calithera Biosciences, Celldex, Eisai, Exelixis, Genentech, GlaxoSmithKline, Immunomedics, Janssen, Merck, NewLink Genetics, Novartis, Pfizer, Prometheus, Rexahn Pharmaceuticals, Sanofi, Takeda and TRACON Pharma.