Pfizer Inc. (NYSE: PFE) has announced encouraging topline results from the final prespecified overall survival (OS) analysis of the TALAPRO-2 study, evaluating TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide), an androgen receptor pathway inhibitor (ARPI). This study focused on patients with metastatic castration-resistant prostate cancer (mCRPC) and revealed a statistically significant and clinically meaningful improvement in OS for all participants (cohort 1) as well as for those with homologous recombination repair (HRR) gene mutations (cohort 2), in comparison to treatment with XTANDI alone.
“The TALAPRO-2 findings demonstrate that TALZENNA combined with XTANDI is the first PARP inhibitor in conjunction with an ARPI to achieve significant survival benefits for patients with metastatic castration-resistant prostate cancer, irrespective of mutation status,” stated Roger Dansey, M.D., Chief Development Officer, Oncology, Pfizer. “Our commitment to advancing scientific innovation in genitourinary cancers is underscored by these exciting TALAPRO-2 results, which aim to enhance survival rates for men battling prostate cancer.”
Dr. Neeraj Agarwal, FASCO, Professor and Presidential Endowed Chair of Cancer Research at Huntsman Cancer Institute, University of Utah, and the global lead investigator for TALAPRO-2, remarked, “These overall survival results suggest a potentially practice-changing efficacy for TALZENNA in combination with XTANDI for men facing metastatic castration-resistant prostate cancer. This advanced and aggressive stage of the disease highlights the pressing need for effective treatment options, and the TALAPRO-2 findings provide significant hope for patients.”
The final analysis confirmed that the clinically meaningful improvement in radiographic progression-free survival (rPFS) observed in both cohorts was consistent with findings from the previously reported primary analysis published in The Lancet. Moreover, the safety profile of the TALZENNA and XTANDI combination was generally aligned with the established safety profiles of both medications. Comprehensive results from the TALAPRO-2 study will be submitted for presentation at an upcoming medical conference, and this data will also be shared with global health authorities to support potential regulatory filings aimed at updating and expanding the approved label for TALZENNA.
