XTANDI plus Leuprolide improves survival outcomes in Non-Metastatic Hormone-Sensitive Prostate Cancer

 Pfizer and Astellas Pharma release their new topline results from the overall survival analysis from the Phase 3 EMBARK study evaluating XTANDI, in combination with leuprolide and as a monotherapy, in men with non-metastatic hormone-sensitive prostate cancer with biochemical recurrence  at high risk for metastasis.

Note that patients treated versus placebo plus leuprolide, EMBARK met the key secondary endpoint with a statistically significant and clinically meaningful improvement in OS. Results also showed a favorable trend towards improved OS for patients treated with XTANDI monotherapy versus placebo plus leuprolide, however the difference did not reach statistical significance. No new safety signals were observed in the analysis, and the safety results were consistent with the demonstrated safety profile of XTANDI.

“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 data,” said Neal Shore, M.D., F.A.C.S, START Carolinas/Carolina Urologic Research Center. “While men with nmHSPC with high-risk BCR now have expanded treatment choices, these results demonstrate a clear clinical benefit, including both MFS and OS, supporting the clinical practice of initiating XTANDI for these patients.”

“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, M.D., 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.”

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Related Topics and Keywords

leuprolide, Non-Metastatic Hormone-Sensitive Prostate Cancer, Pfizer, pfzer, prostate cancer, XTANDI®