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EMBARK: Significant OS gains seen with enzalutamide plus leuprolide in nmHSPC

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Key Takeaways

  • Enzalutamide plus leuprolide acetate significantly improves overall survival in nmHSPC with high-risk biochemical recurrence.
  • The EMBARK trial demonstrated a statistically significant improvement in metastasis-free survival with enzalutamide plus leuprolide acetate.
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According to the news release, detailed OS data from EMBARK are set to be presented at an upcoming medical conference.

Treatment of non-metastatic hormone-sensitive prostate cancer (nmHSPC) with enzalutamide (Xtandi) in combination with leuprolide acetate was associated with significantly improved overall survival (OS), Pfizer Inc and Astellas Pharma Inc reported.1

The data are part of the phase 3 EMBARK trial (NCT02319837), and they indicate that enzalutamide plus leuprolide acetate is associated with a statistically significant and clinically meaningful improvement in OS compared with placebo plus leuprolide acetate. Improved OS was also observed with enzalutamide monotherapy vs placebo plus leuprolide acetate, although a statistical difference was not seen. The recent analysis did not identify any new safety signals.

Neal D. Shore, MD, FACS

Neal D. Shore, MD, FACS

“These data demonstrate that treatment with Xtandi can extend life for men with nmHSPC and high-risk BCR who have relapsed after initial curative-intent therapy with prostatectomy, radiation therapy, or both, further validating EMBARK’s metastasis-free survival (MFS) data,” said Neal D. Shore, MD, FACS, START Carolinas/Carolina Urologic Research Center, Myrtle Beach, South Carolina in a news release from Pfizer and Astellas Pharma. “[Although] men with nmHSPC with high-risk BCR now have expanded treatment choices, these results demonstrate a clear clinical benefit, including both MFS [metastasis-free survival] and OS, supporting the clinical practice of initiating Xtandi for these patients.”1

EMBARK enrolled patients with prostate cancer who had high-risk biochemical recurrence. Patients had a screening prostate-specific antigen (PSA) level of at least 1 ng/mL after radical prostatectomy or at least 2 ng/mL above the nadir for primary external beam radiation therapy, had a PSA doubling time of 9 months or less, no metastases on bone scan or CT/MRI, and a testosterone level of at least 150 ng/dL. The primary end point was MFS by blinded independent central review (BICR) for enzalutamide plus leuprolide acetate vs leuprolide acetate alone. Secondary end points included MFS by BICR for enzalutamide monotherapy vs leuprolide acetate alone, time to PSA progression, time to first use of antineoplastic therapy, and overall survival. Safety was an additional secondary end point. Patients were randomly assigned 1:1:1 to enzalutamide plus leuprolide acetate, placebo plus leuprolide acetate, and enzalutamide monotherapy.

Findings from EMBARK were published in 2023 in the New England Journal of Medicine. Investigators reported that the primary end point of MFS was achieved, with a statistically significant and clinically meaningful improvement observed for patients receiving enzalutamide plus leuprolide acetate vs placebo plus leuprolide acetate.2

“Xtandi is the only androgen receptor inhibitor-based regimen to demonstrate a survival benefit in metastatic HSPC and nmHSPC with high-risk BCR, as well as castration-resistant prostate cancer, highlighting its significant patient impact in advanced prostate cancer,” said Johanna Bendell, MD, Oncology Chief Development Officer, Pfizer. “These positive results add to the robust clinical support for the use of Xtandi and broaden clinical confidence, offering men with high-risk BCR evidence that they might live longer when they start Xtandi early.”

“Over 1.5 million men with advanced prostate cancer around the world have benefited from treatment with Xtandi since its initial approval in 2012,” said Shontelle Dodson, Executive Vice President, Head of Medical Affairs, Astellas. “The scope and rigor of the EMBARK trial exemplify Astellas’ and Pfizer’s longstanding commitment to the prostate cancer community, and we look forward to sharing detailed findings in a future scientific forum.”

According to the release, detailed OS data from EMBARK are set to be presented at an upcoming medical conference.1

REFERENCES

1. XTANDI plus leuprolide significantly improves survival outcomes in men with non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence. News release. Pfizer Inc and Astellas Inc. July 10, 2025. Accessed July 10, 2025. https://www.businesswire.com/news/home/20250710409204/en/XTANDI-Plus-Leuprolide-Significantly-Improves-Survival-Outcomes-in-Men-with-Non-Metastatic-Hormone-Sensitive-Prostate-Cancer-with-High-Risk-Biochemical-Recurrence

2. Freedland SJ, de Almeida Luz M, De Giorgi U, et al. Improved outcomes with enzalutamide in biochemically recurrent prostate cancer. N Engl J Med. 2023;389(16):1453-1465. doi:10.1056/NEJMoa2303974

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