Pfizer and Astellas Pharma have announced the Phase 4 PLATO study, evaluating the efficacy and safety of continued treatment with Xtandi (enzalutamide), plus abiraterone acetate and prednisone as compared to treatment with abiraterone acetate and prednisone alone.
Companies said in their press release that the drug did not meet its primary endpoint of improvement in progression-free survival (PFS) in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (CRPC) whose prostate-specific antigen (PSA) has previously progressed on Xtandi.
“While the PLATO trial did not meet its primary endpoint, it is critical that we continue to focus on addressing the unmet needs of men with metastatic CRPC, who have a poor prognosis despite treatment advances,” said Mohammad Hirmand, M.D., interim chief medical officer at Medivation, Inc., which is now part of Pfizer. “We will continue to analyze these data to better understand the results with the goal of further helping these patients.”
“Xtandi continues to remain an important treatment option for men with metastatic CRPC and their physicians. We are committed to continuing to explore the clinical potential of Xtandi across the disease continuum,” said Steven Benner, M.D., senior vice president, therapeutic area head for oncology development, Astellas.
Xtandi is approved by the U.S. Food and Drug Administration for the treatment of patients with metastatic castrate-resistant prostate cancer (CRPC), based on clinical studies showing statistically significant overall survival benefit versus placebo.