On Thursday, Pfizer Inc. (NYSE:PFE) revealed results from the Phase 3 TALAPRO-2 study of Talzenna (talazoparib) in combination with Xtandi (enzalutamide).

The trial demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared to placebo plus Xtandi in patients with metastatic castration-resistant prostate cancer (mCRPC), with or without homologous recombination repair (HRR) gene mutations.

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The TALAPRO-2 study evaluated two sets of patients, unselected (cohort 1) and selected for HRR gene-mutations (cohort 2).

Overall survival was a prespecified, alpha-protected key secondary endpoint.

After more than four years of median follow-up (52.5 months), the median OS in cohort 1 was 45.8 months with Talzenna in combination with Xtandi and 37.0 months with Xtandi and placebo, representing a 20% reduction in the risk of death, representing a nearly 9-month gain in median OS versus standard of care Xtandi.

In Cohort 2, a statistically significant and clinically meaningful improvement in OS was observed in patients with HRR-mutated mCRPC.

At a median follow-up of 44.2 months, the median OS was 45.1 months with Talzenna in combination with Xtandi and 31.1 months with Xtandi and placebo, a 38% reduction in the risk of death, representing a 14-month gain in median OS versus standard of care Xtandi in a patient population with a historically poor prognosis.

The OS improvement in the HRR-mutated population was observed in patients with BRCA and non-BRCA gene alterations.

At the time of the final analysis, updated radiographic progression-free survival (rPFS) and other secondary efficacy endpoints demonstrated maintained clinical benefit in both cohorts and were consistent with the primary analyses previously reported and published in The Lancet and Nature Medicine.

Price Action: Pfizer stock is up 0.04% at $25.65 at last check Friday.

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