Exelixis Rises on Positive Late-Stage Trial Results

Health and Healthcare

Published: February 1, 2016 9:05 am

Last Updated: January 13, 2020 1:50 pm

Exelixis Inc. (NASDAQ: EXEL) was rising early Monday following the release of positive results from its late-stage trial of cabozantinib. The company announced positive overall survival (OS) results from METEOR, the Phase 3 pivotal trial comparing cabozantinib to everolimus in 658 patients with advanced renal cell carcinoma (RCC). Exelixis plans to present these data to both U.S. and EU regulators at a medical meeting later in the year.

In a second interim analysis for OS, a secondary endpoint of the trial, the results showed a highly statistically significant and clinically meaningful increase in OS for patients randomized to cabozantinib as compared to everolimus. Ongoing study monitoring did not identify any new safety signals.

Despite announcing that there were positive results, Exelixis did not dive into any real specifics for cabozantinib. Instead the company laid out its plan with the U.S. Food and Drug Administration (FDA) for a Prescription Drug User Fee Act (PDUFA) action date later this year. Separately, the European Medicines Agency (EMA) validated Exelixis’ Marketing Authorization Application (MAA) for cabozantinib as a treatment for patients with advanced RCC who have received one prior therapy.