Pfizer, Astellas Tout Positive Xtandi Data To Potentially Expand Label For The Prostate Cancer Drug - Astellas Pharma (OTC:ALPMY), Astellas Pharma (OTC:ALPMF), Pfizer (NYSE:PFE)

Pfizer Inc PFE and Astellas Pharma Inc ALPMY released topline results from the Phase 3 EMBARK trial evaluating Xtandi (enzalutamide) in non-metastatic hormone-sensitive prostate cancer.
The FDA first approved Xtandi in 2012 for castration-resistant prostate cancer (CRPC), who had previously received docetaxel and was granted approval in 2014 for chemotherapy-naïve men with metastatic CRPC.
The study, looking at Xtandi plus leuprolide and Xtandi as monotherapy in men with non-metastatic hormone-sensitive prostate cancer, met its primary endpoint with a "statistically significant and clinically meaningful improvement" in metastasis-free survival in the patients treated with Xtandi plus leuprolide.
At the time of the analysis, a positive trend in the key secondary endpoint of overall survival (OS) was also observed, but these data were not yet mature.
Also Read: Novartis' Prostate Cancer Therapy Hit By Supply Crunch, Seeks To Ramp Up Production To Ease Supply Issues.
Patients in the trial will be followed for a subsequent final OS analysis.
The study also met a key secondary endpoint with a statistically significant and clinically meaningful improvement in MFS for patients treated with Xtandi monotherapy versus placebo plus leuprolide.
Additional key secondary endpoints reached statistical significance, including time to prostate-specific antigen (PSA) progression and time to first use of new antineoplastic therapy.
Other secondary endpoints are being analyzed.
No new safety signals have been observed in the preliminary safety analysis.
Price Action: PFE shares are up 0.04% at $40.39 on the last check Friday.

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