On October 19,2025, the latest clinical trial results from the European Society of Medical Oncology (ESMO) Annual Meeting in Berlin, Germany, revealed that an innovative treatment for high-risk prostate cancer has shown significant efficacy. The XTANDI® (enzalutamide) combined with leuprolide regimen, jointly developed by Pfizer Inc. and Astellas Pharma U.S. Inc., achieved a breakthrough in treating male patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC) who have high-risk biochemical recurrence (BCR).
Survival rates increased significantly and the risk of death decreased by 40 percent
The final overall survival (OS) analysis from the pivotal Phase III EMBARK clinical trial demonstrated that XTANDI in combination with leuprolide reduced patient mortality by 40.3% compared to leuprolide monotherapy. The hazard ratio (HR) was 0.597, with a 95% confidence interval of 0.444 to 0.804 and a p-value of 0.0006, indicating highly significant statistical significance.
Even more encouraging are the long-term survival data: 8-year survival rates of 78.9% for patients receiving the combination regimen versus 69.5% for those receiving leuprolide alone. This means more patients have a chance of long-term survival.
Filling the gap in treatment, it is the first therapy to show survival benefit
This study focuses on a specific subgroup of prostate cancer patients who have undergone radical prostatectomy or localized treatments such as radiotherapy, followed by biochemical recurrence (elevated prostate-specific antigen [PSA] levels) with a PSA doubling time of ≤9 months. Statistics indicate that approximately 20% to 40% of patients receiving radical treatment will experience biochemical recurrence within 10 years. Among these high-risk patients, about 90% will eventually develop metastatic disease, with approximately one-third succumbing to the condition.
The EMBARK study confirmed that the XTANDI plus leuprolide regimen is the first and currently the only androgen receptor inhibitor-based treatment to demonstrate overall survival benefits in this high-risk patient population. Additionally, the study evaluated XTANDI monotherapy, which also showed superior efficacy compared to leuprolide monotherapy.
The study data are solid and safety is known
The study's findings were presented at the ESMO Annual Meeting's key oral presentation on October 19,2025, and simultaneously published in the prestigious journal The New England Journal of Medicine. This marks the eighth publication of XTANDI-related research in this top-tier journal, underscoring its academic significance.
The study featured a median follow-up period of approximately 94 months (7.8 years), ensuring data reliability. In terms of safety, XTANDI demonstrated consistent performance with prior studies, with no new safety signals identified. The most common adverse reactions were hot flashes and fatigue in the combination therapy group, while the monotherapy group experienced frequent side effects including gynecomastia, hot flashes, and fatigue.
The safety features of the protocol are known and controllable, providing a reliable treatment option for doctors and patients, experts said.
Change treatment strategies and promote early intervention
The research findings have been highly praised by experts. Dr. Stephen J. Freedland, Director of Comprehensive Cancer Research at Sidis-Sinai Medical Center, stated that these results highlight the pivotal role of Enzalutamide in extending survival for high-risk patients with biochemical recurrence who have not shown metastases on conventional imaging, thereby supporting the benefits of initiating Enzalutamide therapy earlier.
Dr. Johanna Bendell, Chief Development Officer of Pfizer Oncology, stressed that early intervention is critical, as up to 90% of high-risk patients with biochemical recurrence will develop metastatic disease. The final analysis of the EMBARK trial showed that XTANDI in combination with leuprolide improved outcomes and extended survival in men with high-risk biochemical recurrence who had received prior curative local therapy.
Shontelle Dodson, Head of Medical Affairs at Astellas Pharma, stated that these findings reinforce XTANDI's position as a cornerstone therapy in the active management of such patients.
About EMBARK Research and XTANDI
EMBARK is a randomized, double-blind, placebo-controlled international multicenter Phase III clinical trial involving 1,068 patients. The study's primary endpoint, progression-free survival (PFS), achieved positive results in 2023, which formed the basis for XTANDI's approval for this patient population that same year.
XTANDI, an androgen receptor (AR) signal inhibitor, has been approved for over 80 countries worldwide, including the United States, the European Union, and Japan, for treating various prostate cancer indications such as metastatic castration-resistant prostate cancer and metastatic hormone-sensitive prostate cancer. To date, more than 1.5 million patients globally have received XTANDI treatment.
This breakthrough study offers new hope for patients with high-risk biochemical recurrence of non-metastatic prostate cancer, marking a new phase of prostate cancer treatment that emphasizes early intervention and precision management.
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