Pfizer’s xtandi plus leuprolide improves survival in prostate cancer

Pfizer (PFE) and Astellas Pharma (ALPMY) announced positive topline results from the overall survival, or OS, analysis from the Phase 3 EMBARK study evaluating xtandi – enzalutamide -, in combination with leuprolide and as a monotherapy, in men with non-metastatic hormone-sensitive prostate cancer, or nmHSPC, with biochemical recurrence at high risk for metastasis. For patients treated with xtandi plus leuprolide vs. 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 vs. 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. An initial analysis was previously reported in The New England Journal of Medicine in 2023, demonstrating that the study met its primary endpoint with a statistically significant and clinically meaningful improvement in MFS for patients treated with XTANDI plus leuprolide versus placebo plus leuprolide. The most common adverse events in the combination group and the leuprolide-alone group were hot flashes and fatigue. The most common adverse events in the monotherapy group were gynecomastia, hot flashes, and fatigue. Xtandi is currently approved in more than 80 countries, including in the United States, EU, and Japan.