Pfizer Inc. and Astellas Pharma U.S. Inc. revealed final overall survival results from the Phase 3 EMBARK trial studying XTANDI, in combination with leuprolide and as monotherapy, in men with non‑metastatic hormone‑sensitive prostate cancer with high‑risk biochemical recurrence (BCR). The study found that XTANDI plus leuprolide reduced the risk of death by 40.3% compared with leuprolide alone (Hazard Ratio [HR]: 0.597; 95% Confidence Interval [CI]: 0.444‑0.804; p = 0.0006). This makes it the first androgen receptor inhibitor‑based regimen to show an overall survival benefit in this patient population. Eight‑year overall survival was 78.9% (95% CI: 73.9%–83.1%) in the XTANDI plus leuprolide group versus 69.5% (95% CI: 64.0%–74.3%) in the leuprolide alone group. A numerical improvement in overall survival for XTANDI monotherapy versus leuprolide alone (HR: 0.83; 95% CI: 0.63‑1.095; p = 0.1867) did not reach statistical significance.

“These findings highlight the central role of enzalutamide in extending survival for men with nmHSPC and high‑risk BCR,” said Stephen J. Freedland, M.D., Director of the Center for Integrated Research in Cancer and Lifestyle at Cedars‑Sinai and Associate Director for Training and Education at the Samuel Oschin Comprehensive Cancer Institute. “These data reinforce the benefits of earlier treatment initiation with enzalutamide.”

The median follow‑up time was 94.2 months for the XTANDI plus leuprolide arm, 94.0 months for the leuprolide alone arm, and 93.8 months for the XTANDI monotherapy arm. The safety profile of XTANDI was consistent with previous analyses and no new safety signals were identified. In the combination arm the most common adverse events (occuring in ≥10% of patients) were hot flashes and fatigue. In the monotherapy group, the most common events included gynecomastia, hot flashes and fatigue.

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“Early intervention with effective therapy is critical given that up to 90 percent of men with high‑risk BCR will develop metastases,” said Johanna Bendell, M.D., Chief Development Officer, Oncology at Pfizer. “The final analysis from EMBARK shows that XTANDI plus leuprolide improved outcomes and extended lives for men facing high‑risk BCR after curative‑intent local therapy.”

Among men who undergo definitive prostate cancer treatment—such as radical prostatectomy, radiotherapy or both—an estimated 20‑40 percent will experience biochemical recurrence within ten years. About nine in ten men with high‑risk BCR will develop metastatic disease and one in three will die as a result of their metastatic cancer.

“This marks the eighth publication of XTANDI data in The New England Journal of Medicine, reinforcing XTANDI’s profound impact on clinical outcomes in men with certain advanced types of prostate cancer,” said Shontelle Dodson, Executive Vice President, Head of Medical Affairs at Astellas. “These findings confirm XTANDI’s position as a cornerstone therapy in the proactive management of these patients.”

The EMBARK trial initially met its primary endpoint in 2023, demonstrating that XTANDI plus leuprolide significantly improved metastasis‑free survival (MFS) versus leuprolide alone (HR: 0.42; 95% CI: 0.30‑0.61; p < 0.001). XTANDI monotherapy also showed a statistically significant MFS benefit (HR: 0.63; 95% CI: 0.46‑0.87; p = 0.005). XTANDI is approved for multiple prostate cancer indications in over 80 countries, including the United States, European Union and Japan.

Descriptive updates of several secondary and exploratory endpoints—including time to new antineoplastic therapy, time to first symptomatic skeletal event and time to progression on subsequent therapy—were consistent with the primary analyses announced based on the 2023 data cutoff.

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