Exelixis announced positive top-line results from the primary analysis of METEOR, a Phase 3 trial comparing Cometriq (cabozantinib) to everolomus in patients with metastatic renal cell carcinoma (RCC) who have experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor (TKI).
METEOR is an open-label, event-driven trial that randomized 658 patients 1:1 to receive cabozantinib 60mg or everolimus 10mg. They were stratified based on the number of prior VEGF receptor TKI therapies received, and on commonly applied RCC risk criteria. No cross-over was allowed between the study arms. The primary endpoint was progression-free survival (PFS).
The trial met its primary endpoint of demonstrating a statistically significant increase in PFS in the first 375 randomized patients. Cabozantinib reduced the risk of disease progression or death by 42% compared to the everolimus arm (HR=0.58, 95% CI 0.45–0.75, P<0.0001).
Cometriq is already indicated for the treatment of progresive, metastatic medullary thyroid cancer (MTC).
For more information call (650) 837-7000 or visit Exelixis.com.