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Exelixis Announces Outcome from First Planned Interim Analysis of the Phase 3 CELESTIAL Trial of Cabozantinib in Patients with Advanced Hepatocellular Carcinoma
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Sep. 6, 2016-- Exelixis, Inc. (NASDAQ:EXEL) today 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
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Source: press release, 9/06/16. http://www.exelixis.com/investors-media/press-releases

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Gisela M. Schwab, MD, EVP and CMO, gave guidance for data from the phase-III CELESTIAL study of Cabozantinib in hepatocellular carcinoma. She stated, "Now turning to our second ongoing phase-III study in advanced hepatocellular cancer, CELESTIAL. The study continues to enroll patients globally. In this study patients with advanced HCC, who have received prior treatment with sorafenib are randomized to receive either cabozantinib at 60 mg per day or matching placebo. The primary endpoint for this trial is overall survival and we are expecting results in the 2017 timeframe."
Source: Q4 2015 earnings conference call, 2/29/16.

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Gisela M. Schwab, MD, EVP and CMO, gave guidance for data from the phase-III CELESTIAL study of Cabozantinib in hepatocellular carcinoma. She stated, "On other trials, our hepatocellular cancer phase-III study CELESTIAL is making progress in its targeted enrollment of 760 patients and we continue to expect top-line data in the 2017 time frame. The CTEP and IST programs are also making progress. These studies together with our internal studies in totality make up more than 45 planned or ongoing studies of Cabozantinib in a variety of tumor types."
Source: Q1 2015 earnings conference call, 4/30/15.

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Gisela M. Schwab, MD, EVP and CMO, gave guidance for data from the Cabozantinib RCC and HCC programs. She stated, "We are very encouraged by the enthusiasm for these trials in the medical community, both studies are off to a good start and we hope to see top-line data on RCC in 2015 and on HCC in the 2016 or 17 time-frame."
Source: Q4 2013 earnings conference call, 2/20/14.

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CELESTIAL - A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib
Estimated Enrollment: 760
Study Start Date: August 2013
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01908426?term=Cabozantinib&phase=2...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Cabozantinib - Hepatocellular carcinomaOncologyHepatocelluar carcinomaTyrosine kinase inhibitorc-Met and VEGFR-2

Mechanism of action: Cabozantinib is an orally bioavailable, small molecule receptor tyrosine kinase (RTK) inhibitor with potential antineoplastic activity. Cabozantinib strongly binds to and inhibits several tyrosine receptor kinases. Specifically, cabozantinib appears to have a strong affinity for the hepatocyte growth factor receptor (Met) and vascular endothelial growth factor receptor 2 (VEGFR2), which may result in inhibition of tumor growth and angiogenesis, and tumor regression. This agent has also been shown to inhibit mast/stem cell growth factor (KIT), FMS-like tyrosine kinase 3 (Flt3) and tyrosine-protein kinase receptor (Tie-2).

Phase of Development: III

Event Type: Data: Phase III trial results (interim)

Dates: 2017-01-01 - 2017-06-30

Results: Pending