No OS improvement for cabozantinib in MTC

Exelixis Inc. (NASDAQ:EXEL) released an abstract showing no difference between cabozantinib and placebo in overall survival at an interim analysis in the Phase III EXAM trial in 330 patients with advanced medullary thyroid cancer (MTC). The trial has reached 44% of the 217 required events. Cabozantinib did significantly improve objective response rate vs. placebo (28% vs. 0%, p<0.0001). Data will be presented at the American Society of Clinical Oncology meeting that starts June 1 in Chicago.

ORR and OS are both secondary endpoints in the trial. Last October, Exelixis said cabozantinib met the primary endpoint of progression-free survival (PFS) vs. placebo (11.2 vs. 4 months, p<0.0001). In December, Exelixis began submission of a rolling NDA to FDA for cabozantinib to treat MTC. The company plans to complete the submission this half. Exelixis was off $0.23 to $4.69 on Thursday. ...