Pfizer, Astellas Tout Positive Xtandi Data To Potentially Expand Label

 

• Pfizer Inc 
  PFE-0.41%+ Free Alerts
   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. 
• 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.

https://www.benzinga.com/general/biotech/23/03/31397615/pfizer-astellas-tout-positive-xtandi-data-to-potentially-expand-label-for-the-prostate-cancer-dru