Pfizer’s talzenna plus xtandi shows improved survival in prostate cancer

Pfizer (PFE) announced positive topline results from the Phase 3 TALAPRO-3 study of talzenna – talazoparib -, an oral poly ADP-ribose polymerase, or PARP, inhibitor, in combination with xtandi – enzalutamide -, an androgen receptor pathway inhibitor, or ARPI, in people with homologous recombination repair, or HRR, gene-mutated metastatic castration-sensitive prostate cancer – or mCSPC -, also known as metastatic hormone-sensitive prostate cancer, mHSPC. The study met its primary endpoint, with talzenna plus xtandi demonstrating a statistically significant and clinically meaningful improvement in radiographic progression-free survival vs. placebo plus xtandi. The results markedly exceeded the pre-specified target hazard ratio of 0.63, with the majority of patients remaining progression-free at the time of analysis. At the time of interim analysis, results showed a strong trend toward improved overall survival, a key secondary endpoint. Benefits were also observed in other secondary endpoints, including overall response rate, duration of response, and time to Prostate-Specific Antigen progression. The safety of talzenna plus xtandi was consistent with the known safety profile of each medicine, and no new safety signals were identified. The TALAPRO-3 results will be submitted for presentation at an upcoming medical congress and will be discussed with global health authorities for potential regulatory submissions.