Talzenna (talazoparib) + Xtandi (enzalutamide) prolongs overall survival in phase III TALAPRO-2 trial for prostate cancer

Pfizer Inc. announced positive topline results from the final prespecified overall survival (OS) analysis of the TALAPRO-2 study of Talzenna  (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide), an androgen receptor pathway inhibitor (ARPI), in patients with metastatic castration-resistant prostate cancer (mCRPC). Results showed a statistically significant and clinically meaningful improvement in the final OS in all-comers (cohort 1) as well as in those patients with homologous recombination repair (HRR) gene-mutated mCRPC (cohort 2), compared to Xtandi alone.

“The TALAPRO-2 results showed that Talzenna plus Xtandi is the first and only PARP inhibitor in combination with an ARPI to significantly improve survival in patients with metastatic castration-resistant prostate cancer, regardless of mutation status,” said Roger Dansey, M.D., Chief Development Officer, Oncology, Pfizer. “Pfizer is dedicated to advancing scientific breakthroughs in genitourinary cancers, and these exciting TALAPRO-2 results further highlight our long-standing commitment to improving survival for men with prostate cancer.”

“These overall survival results indicate potentially practice-changing efficacy for Talzenna in combination with Xtandi for men with metastatic castration-resistant prostate cancer,” said Neeraj Agarwal, M.D., FASCO, Professor and Presidential Endowed Chair of Cancer Research at Huntsman Cancer Institute, University of Utah, and global lead investigator for TALAPRO-2. “Metastatic castration-resistant prostate cancer is the most advanced and aggressive stage of the disease, and the TALAPRO-2 results provide much-needed hope to patients who remain in high unmet need for effective treatment options.”

At the time of the final analysis, the clinically meaningful improvement in radiographic progression free survival (rPFS) was maintained in both cohorts from the prior primary analysis previously reported and published in The Lancet . In addition, the safety profile of Talzanna plus XtandiI was generally consistent with the known safety profile of each medicine. Detailed results from TALAPRO-2 will be submitted for presentation at an upcoming medical congress. These data will also be shared with global health authorities to potentially support regulatory filings to update and potentially expand the approved label for Talzenna.

Talzenna combination withXtandi was approved by the  FDA for the treatment of adult patients with HRR gene-mutated mCRPC in June 2023. The combination was also approved by the European Commission in January 2024 for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated. Talzanna is the first and only PARP inhibitor licensed in the European Union for use with Xtandi  for patients with mCRPC, with or without gene mutations. Ta;lzanna in combination with XTANDI is now approved in more than 35 countries globally for patients with mCRPC.

Citation:Talazoparib plus enzalutamide in men with first- line metastatic castration resistant prostate cancer (TALAPRO-2) a randomised placebo-controlled phase III trial. The Lancet. Vol. 402No. 10398p291–303Published: June 4, 2023; Neeraj Agarwal,Joan Carles MD, Prof Andre P Fay, MD, Prof Nobuaki Matsubara, MD, Daniel Heinrich MD, et al. Published:June 04, 2023.DOI:https://doi.org/10.1016/S0140-6736(23)01055-3..