Exelixis, Inc. (EXEL) on Monday announced positive top-line results from the primary analysis of METEOR, the phase 3 pivotal trial comparing cabozantinib to everolimus in patients with metastatic renal cell carcinoma (RCC).
The pivotal phase 3 trial enrolled 658 patients who have experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor.
The company said the trial met its primary endpoint of demonstrating a statistically significant increase in progression-free survival in the first 375 randomized patients. Cabozantinib reduced the risk of disease progression or death by 42 percent compared to the everolimus arm.
Data pertaining to overall survival, a secondary endpoint of the trial, were immature at the data cutoff, although it favored cabozantinib.
Based on the outcome of METEOR, Exelixis plans to complete regulatory filings in the United States and European Union in early 2016. Cabozantinib received Fast Track designation by the U.S. Food and Drug Administration in April, 2015.
For comments and feedback contact: editorial@rttnews.com
Business News