Exelixis (EXEL) Updates on Cabozantinib Phase 3 in Adv. HCC; IDMC Says Study Should Continue Unmodified

September 6, 2016 5:10 PM EDT

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Exelixis, Inc. (Nasdaq: EXEL) announced the outcome from the first planned interim analysis of CELESTIAL, a randomized global phase 3 trial of cabozantinib compared with placebo in patients with advanced hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Following this interim analysis, which was scheduled to take place when 50 percent of the events for the primary endpoint of overall survival (OS) had occurred, the trial’s Independent Data Monitoring Committee (IDMC) determined that the study should continue without modifications per the study protocol. The trial protocol calls for a second interim analysis to take place once 75 percent of events have been observed.

HCC is the most common form of liver cancer and the third-leading cause of cancer deaths worldwide.1 The disease originates in cells called hepatocytes, which make up the majority of the liver.2 Without treatment, patients with advanced disease usually survive less than 6 months.3 During 2003-2012, deaths in the U.S. from liver cancer increased at the highest rate of all cancer sites.4 In 2016 it is estimated that over 39,000 new cases and over 27,000 deaths occurred in the U.S. due to liver cancer.5 Across the U.S., EU5 (Italy, France, Germany, Spain, and United Kingdom), and Japan, it is estimated that approximately 117,000 new cases will be diagnosed in 2017.4,6-8 Liver cancer is a leading cause of cancer-related mortality worldwide, accounting for more than 700,000 deaths each year. 9

Cabozantinib is not approved for the treatment of HCC.

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