Phase III TALAPRO-2 study of Talzenna with Xtandi meets primary endpoint in prostate cancer
Pfizer announced positive topline results from the Phase III TALAPRO-2 study of Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi (enzalutamide) compared to placebo plus Xtandi in men with metastatic castration-resistant prostate cancer (mCRPC), with or without homologous recombination repair (HRR) gene mutations
The study met its primary endpoint with a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) compared with placebo plus Xtandi. The results of the primary endpoint exceeded the pre-specified hazard ratio of 0.696.
Results showed a trend toward improved overall survival, a key secondary endpoint, at the time of the analysis, but these data are not yet mature. Benefits were also observed in other secondary endpoints, including investigator assessed rPFS, prostate specific antigen (PSA) response, time to PSA progression, and overall response rate. Other secondary endpoints are being analyzed. At the time of topline analysis, the safety of Talzenna plus Xtandi were generally consistent with the known safety profile of each medicine. Detailed results from TALAPRO-2 will be submitted for presentation at a near-term medical congress. These data will also be shared with global regulatory authorities to potentially support a regulatory filing.
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