Pfizer's acquired Xtandi fails to meet its primary endpoint in study

Phase IV study demonstrates a lack of improvement in progression-free survival in patients with chemotherapy-naïve metastatic CRPC whose prostate-specific antigen 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, interim chief medical officer at Medivation, which is now part of Pfizer. “We will continue to analyse 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, senior vice president, therapeutic area head for oncology development, Astellas.

Xtandi is approved by the FDA for the treatment of patients with metastatic castrate-resistant prostate cancer (CRPC), based on clinical studies showing statistically significant overall survival benefit versus placebo.