Positive results in phase III analysis of Cometriq (cabozantinib) in renal cell carcinoma- Exelixis

Exelixis announced positive results from a post-hoc analysis of METEOR, the phase III pivotal trial comparing Cometriq (cabozantinib) to everolimus in 658 patients with renal cell carcinoma who have experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor (TKI).

In July 2015, Exelixis disclosed that the trial met its primary endpoint, demonstrating a statistically significant increase in progression-free survival for patients in the cabozantinib arm. In a post-hoc subset analysis of patients who had received sunitinib, the most commonly used first-line therapy, as their only prior VEGF receptor TKI, the median PFS for cabozantinib-treated patients (n=76) was 9.1 months versus 3.7 months for everolimus-treated patients (n=77). This corresponds to a 59% reduction in the rate of disease progression or death for patients treated with cabozantinib. Data pertaining to overall survival in the entire study population of 658 patients, a secondary endpoint of the trial, were immature at the data cutoff.