Pfizer and Astellas announce positive topline results from Phase 3 EMBARK trial


Pfizer Inc. and Astellas Pharma Inc. published favorable baseline results from the Phase 3 EMBARK trial evaluating XTANDI® in men with hormone-responsive, non-metastatic prostate cancer at high risk for biochemical recurrence. Patients participating in the trial were randomized to one of three study arms: XTANDI plus leuprolide, placebo plus leuprolide or XTANDI as monotherapy. The study achieved the primary endpoint with a statistically significant and clinically significant improvement in metastasis-free survival (MFS) for patients treated with XTANDI plus leuprolide compared with patients treated with XTANDI plus leuprolide. with placebo plus leuprolide. At the time of analysis, a positive trend was also observed in the important overall survival (OS) secondary endpoint, but these data are incomplete.

The test patients will be followed up for final OS analysis afterward. The study also achieved an important secondary endpoint with statistically significant and clinically significant improvement in MFS for patients treated with XTANDI monotherapy compared with placebo plus leuprolide. Other important secondary endpoints reached statistical significance, including time to prostate-specific antigen (PSA) progression and time to first use of new anticancer therapy. Other sub-criteria are currently being analyzed. To date, no new safety features have been observed in the preliminary safety analysis, consistent with the established safety profile of XTANDI.

“As the only novel hormone therapy approved for three disease states of prostate cancer in the U.S., XTANDI has impacted hundreds of thousands of men,”

“The topline findings from EMBARK are highly encouraging and we look forward to engaging with health authorities to potentially bring XTANDI to men with non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence.”

Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology and Rare Disease, Pfizer Global Product Development.

“While current treatment options for localized prostate cancer are intended to be curative, some men remain at higher risk for biochemical recurrence following primary treatment, which may result in metastases,”

“The EMBARK trial is the first study to demonstrate a statistically significant improvement in MFS using the combination of XTANDI plus leuprolide in men with this stage of the disease.”

Ahsan Arozullah, M.D., MPH, Senior Vice President and Head of Development Therapeutic Areas, Astellas.

Detailed results from EMBARK will be presented at an upcoming medical meeting. These data will also be discussed with regulators, including the US Food and Drug Administration (FDA), to support potential regulatory submissions for XTANDI in this indication.

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