Pfizer Inc. (NYSE: PFE) has announced positive topline results regarding overall survival (OS) in the Phase III TALAPRO-2 study for Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, when combined with Xtandi (enzalutamide), an androgen receptor pathway inhibitor (ARPI). This combination is used for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).
The TALAPRO-2 study, which aimed to evaluate the efficacy of the talazoparib and enzalutamide combination in mCRPC patients with homologous recombination repair (HRR) gene mutations, met its primary endpoint in October 2022. This showed a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) compared to the placebo group combined with enzalutamide. The latest results indicate a significant improvement in OS for all patients (cohort 1) and those with HRR gene-mutated mCRPC (cohort 2) when compared to talazoparib alone.
This combination therapy stands as the first and only PARP inhibitor combined with an ARPI to demonstrate a survival benefit in patients with mCRPC, irrespective of mutation status. It received approval in the US in 2023 and in the European Union (EU) in 2024 for the treatment of adult patients with HRR gene-mutated mCRPC and adult patients with mCRPC for whom chemotherapy is not clinically recommended, respectively.- Flcube.com
