FDA Approval Insights: Talazoparib Plus Enzalutamide in HRR Gene–Mutated mCRPC

Welcome to OncLive On Air^®! I’m your host today, Ashling Wahner.

OncLive On Air^® is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive^® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, we had the pleasure of speaking with Neeraj Agarwal, MD, about the FDA approval of talazoparib (Talzenna) plus enzalutamide (Xtandi) in patients with metastatic castration-resistant prostate cancer (mCRPC) harboring homologous recombination repair (HRR) gene mutations. Dr Agarwal is a professor of medicine, the Presidential Endowed Chair of Cancer Research, the director of the Genitourinary Oncology Program, and the director of the Center of Investigational Therapeutics at the Huntsman Cancer Institute at the University of Utah in Salt Lake City.

On June 20, 2023, the FDA approved the combination of the PARP inhibitor talazoparib and the androgen receptor inhibitor enzalutamide in patients with HRR gene–mutated mCRPC. The approval was supported by findings from the phase 3 TALAPRO-2 trial (NCT03395197), in which the combination led to a radiographic progression-free survival that was not yet reached (95% CI, 21.9-not evaluable) vs 13.8 months (95% CI, 11.0-16.7) with enzalutamide alone, with a hazard ratio of 0.45 (95% CI, 0.33-0.61; P < .0001).

In our exclusive interview, Dr Agarwal discussed the significance of this approval, key efficacy and safety data from TALAPRO-2, and how this combination further supports the use of PARP inhibitors in the mCRPC treatment paradigm.

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