Exelixis Reports Interim Analysis of Liver Cancer Trial Data
Exelixis, Inc. EXEL announced the outcome from the first planned interim analysis of a randomized phase III trial, CELESTIAL, on cabozantinib.
The trial evaluated cabozantinib, compared with placebo, in patients with advanced hepatocellular carcinoma (HCC) who have been previously treated with Nexavar.
The interim analysis was conducted because 50% of the events for the primary endpoint had occurred. Consequently, an Independent Data Monitoring Committee (IDMC) determined that the study should continue without modifications per the study protocol.
The trial protocol states a second interim analysis has to be conducted once 75% of the events have been observed.
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Exelixis’ lead product, Cometriq (cabozantinib), was approved in the U.S. in 2012 for the treatment of progressive, metastatic medullary thyroid cancer (MTC). In Apr 2016, a tablet formulation of cabozantinib (Cabometyx) was approved in the U.S. for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
The company plans to build cabozantinib into an entire oncology franchise and is evaluating the product in a broad development program consisting of over 45 ongoing or planned clinical trials in additional tumor types. Exelixis has also initiated a phase Ib study (investigator-sponsored) on cabozantinib (in combination with Opdivo or Opdivo plus Yervoy) in patients suffering from genitourinary tumors, including bladder cancer and RCC. Data from the study are expected in 2016. The company is also evaluating cabozantinib, in comparison to Sutent, for the first-line treatment of intermediate or poor-risk RCC patients.
Exelixis currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Actelion Ltd ALIOF, ANI Pharmaceuticals, Inc. ANIP and Pacira Pharmaceuticals PCRX. All these stocks sport a Zacks Rank #1 (Strong Buy).
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