• Primary endpoint met in Phase 3 TALAPRO-3 study demonstrating a statistically significant and clinically meaningful reduction in risk of disease progression or death in HRR gene-mutated metastatic hormone sensitive prostate cancer
  • Consistent rPFS efficacy benefit was observed in patients whose tumors harbored BRCA and non-BRCA HRR gene alterations
  • Interim analysis showed a strong trend toward improvement in overall survival
  • These results will be discussed with global health authorities to potentially expand TALZENNA indication in this earlier stage disease

Pfizer Inc. (NYSE:PFE) today announced positive topline results from the Phase 3 TALAPRO-3 study of TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide), an androgen receptor pathway inhibitor (ARPI), in people with homologous recombination repair (HRR) gene-mutated metastatic castration-sensitive prostate cancer (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 (rPFS), compared to 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. Consistent efficacy benefit was also observed in patients whose tumors harbored BRCA and non-BRCA HRR gene alterations.