- 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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