Exelixis' cabozantinib meets primary endpoint in Phase III trial

US pharma company Exelixis (Nasdaq: EXEL) has announced positive top-line results from the primary analysis of its Phase III pivotal trial comparing cabozantinib to everolimus in patients with metastatic renal cell carcinoma (RCC). The company’s shares surged more than 50% on the announcement on Monday..

The METEOR trial looked at patients who have experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor (TKI). The study met its primary endpoint of demonstrating a statistically-significant increase in progression-free survival (PFS) in the first 375 randomized patients as determined by an independent radiology committee (IRC). Cabozantinib reduced the risk of disease progression or death by 42% compared to the everolimus arm.

However, data pertaining to overall survival (OS) in the entire study population of 658 patients, a secondary endpoint of the trial, were immature at the data cut-off. A pre-specified interim analysis, triggered by the primary analysis for PFS, showed a trend in OS favoring cabozantinib. The trial will continue to the final analysis of OS anticipated in 2016.