04:38 AM EDT, 10/20/2025 (MT Newswires) -- Pfizer ( PFE ) and Astellas Pharma US said Sunday that the drug combination Xtandi and leuprolide for the treatment of prostate cancer reduced the risk of death by 40.3% compared to leuprolide alone in a phase 3 clinical trial.

The specific indication is for men with non-metastatic hormone-sensitive prostate cancer and non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis, the companies said.

The eight-year overall survival rate in the 1,068-patient study was 78.9% for patients receiving the drug combo compared with 69.5% for those receiving leuprolide alone, said the companies, which jointly commercialize Xtandi in the US.

Improvement in overall survival with XTANDI alone did not reach statistical significance, the companies said.

Meanwhile, Xtandi's safety profile was consistent with that observed during a previous analysis, and no new safety signals were identified, the companies said.

Xtandi has already been approved for various indications in more than 80 countries, the companies said.