The Investor
10 Jul 2025, 21:23
XTANDI Plus Leuprolide Significantly Extends Survival in High-Risk Prostate Cancer Patients, Pfizer and Astellas Report
New York & Tokyo, July 10, 2025 – Pfizer and Astellas announced that XTANDI (enzalutamide), in combination with leuprolide, significantly improved overall survival (OS) in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR), based on Phase 3 EMBARK trial results.
The combination therapy achieved a statistically significant and clinically meaningful OS benefit over placebo plus leuprolide, marking XTANDI as the first androgen receptor inhibitor regimen to do so in this patient population. A favorable OS trend was also observed with XTANDI monotherapy, although it did not reach statistical significance.
No new safety concerns emerged. Common side effects included hot flashes, fatigue, and gynecomastia, depending on the treatment group. The EMBARK trial previously demonstrated XTANDI’s benefit in metastasis-free survival (MFS), published in *The New England Journal of Medicine* in 2023.
XTANDI is now the only treatment shown to extend survival across multiple stages of advanced prostate cancer, including mHSPC, nmCRPC, and now nmHSPC with high-risk BCR. Detailed results will be presented at a future medical meeting.
New York & Tokyo, July 10, 2025 – Pfizer and Astellas announced that XTANDI (enzalutamide), in combination with leuprolide, significantly improved overall survival (OS) in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR), based on Phase 3 EMBARK trial results.
The combination therapy achieved a statistically significant and clinically meaningful OS benefit over placebo plus leuprolide, marking XTANDI as the first androgen receptor inhibitor regimen to do so in this patient population. A favorable OS trend was also observed with XTANDI monotherapy, although it did not reach statistical significance.
No new safety concerns emerged. Common side effects included hot flashes, fatigue, and gynecomastia, depending on the treatment group. The EMBARK trial previously demonstrated XTANDI’s benefit in metastasis-free survival (MFS), published in *The New England Journal of Medicine* in 2023.
XTANDI is now the only treatment shown to extend survival across multiple stages of advanced prostate cancer, including mHSPC, nmCRPC, and now nmHSPC with high-risk BCR. Detailed results will be presented at a future medical meeting.