Karim Fizazi, MD, PhD, highlights the TALAPRO-2 trial, which led to the FDA approval of talazoparib plus enzalutamide for patients with HRR gene–mutated metastatic castration-resistant prostate cancer.
In this video, Karim Fizazi, MD, PhD, a medical oncologist at Gustave Roussy, Villejuif, France, discusses the background and results of the phase 3 TALAPRO-2 trial, which led to the FDA approval1 of the combination of talazoparib (Talzenna) and enzalutamide (Xtandi) for the treatment of patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
Fizazi presented data from TALAPRO-2 at the 2023 ASCO Annual Meeting,2 and the FDA approval of the combination came shortly thereafter.
In the HRR gene–altered subgroup of the TALAPRO-2 trial, talazoparib plus enzalutamide reduced the risk of disease progression or death by 55% vs enzalutamide alone in a subgroup of patients with HRR gene–altered mCRPC. The median radiographic progression-free survival (rPFS) was not yet reached (95% CI, 21.9-NR) in patients receiving talazoparib/enzalutamide (n = 200) vs 13.8 months (95% CI, 11.0-16.7) in the control arm (HR, 0.45; 95% CI, 0.33-0.61; P <.0001).2
The rPFS benefit extended to all subgroups of HRR deficient patients, including those with BRCA1/2 mutations. In the BRCA mutation–positive group, the talazoparib combination led to an 80% reduction in the risk of disease progression or death versus the control arm (HR, 0.20; 95% CI, 0.11-0.36, P <.0001). Among patients without BRCA1/2 mutations, there was a much smaller rPFS benefit observed in the talazoparib arm (HR, 0.72; 95% CI, 0.49-1.07; P = 0.10).2
1. Pfizer’s TALZENNA® in Combination with XTANDI® Receives U.S. FDA Approval. Accessed June 21, 2023. https://www.pfizer.com/news/press-release/press-release-detail/pfizers-talzennar-combination-xtandir-receives-us-fda
2. Fizazi K, Azad A, Matsubara N, et al. TALAPRO-2: Phase 3 study of talazoparib (TALA) + enzalutamide (ENZA) versus placebo (PBO) + ENZA as first-line (1L) treatment for patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) harboring homologous recombination repair (HRR) gene alterations. J Clin Oncol. 2023;5004(suppl 16). doi: 10.1200/JCO.2023.41.16_suppl.5004