Exelixis Rises on Positive Late-Stage Trial Results

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.
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Michael M. Morrissey, Ph.D., president and CEO of Exelixis, commented:

With these results, cabozantinib is now the first and only therapy evaluated in a large, pivotal study in previously treated patients with advanced renal cell carcinoma to demonstrate a benefit in all three key efficacy parameters – overall survival, progression-free survival and objective response rate. This is an important moment for the kidney cancer community, including the patients, clinical investigators, and Exelixis team members who made the METEOR trial possible. Exelixis will share these new results with regulators as part of ongoing review processes in the United States and European Union. Our highest priority is to bring this new option for advanced RCC to patients as quickly as possible.

Shares of Exelixis closed Friday up 10.5% at $4.62, with a consensus analyst price target of $11.00 and a 52-week trading range of $1.80 to $6.81. In early trading indications Monday, the stock shot up an additional 3% at $4.75.