Pfizer Inc. (PFE) announced detailed results from the pivotal Phase 3 TALAPRO-3 study evaluating TALZENNA (talazoparib), an oral PARP inhibitor, in combination with XTANDI (enzalutamide), an androgen receptor pathway inhibitor, in men with homologous recombination repair (HRR) gene-mutated metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC).
The combination of TALZENNA plus XTANDI demonstrated a 52% reduction in the risk of radiographic progression or death compared to placebo plus XTANDI. At three years, radiographic progression-free survival (rPFS) rates were estimated at 77% for patients treated with TALZENNA plus XTANDI versus 56% for those treated with placebo plus XTANDI. With a median follow-up of more than 37 months, median rPFS was not reached in the TALZENNA plus XTANDI arm, while it was 46 months in the placebo plus XTANDI arm.
The rPFS benefit with TALZENNA plus XTANDI was consistent across pre-specified patient and disease subgroups, including age, Gleason score, geographic region, PSA level, and BRCA versus non-BRCA HRR gene alteration status. At three years, rPFS rates were 77% versus 49% in patients with BRCA alterations and 76% versus 60% in patients with non-BRCA alterations, compared with placebo plus XTANDI.
Interim overall survival (OS) results showed a strong trend toward improved OS, a key secondary endpoint, with median OS not reached in either treatment arm. TALZENNA plus XTANDI also improved time to PSA progression and time to subsequent anti-cancer therapy compared with placebo plus XTANDI. The trial remains ongoing, and OS will be formally assessed at the final analysis.
The safety profile of TALZENNA plus XTANDI in TALAPRO-3 was consistent with the known profiles of each agent, with no new safety signals identified. The most common treatment-emergent adverse events (TEAEs) in the combination group were anemia, fatigue, decreased neutrophil count, and asthenia. The most frequent grade 3 or higher TEAE was anemia, reported in 51% of patients in the TALZENNA plus XTANDI group compared with 3% in the control group. Five percent of patients discontinued TALZENNA due to anemia. Overall, TEAEs were generally manageable with dose modifications and supportive care.
PFE closed Friday's regular trading at $26.18 up $0.04 or 0.15%.
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