Cabozantinib: Additional Phase III data

Additional data from the double-blind, international Phase III EXAM trial in 330 patients with locally advanced or metastatic MTC showed that once-daily cabozantinib led to a 1-year PFS rate of 47.3% vs. 7.2% for placebo. Median duration of response was 14.6 months. Data were presented at the American Society of Clinical Oncology meeting in Chicago. Exelixis previously reported that cabozantinib met the primary endpoint of PFS vs. placebo (11.2 vs. 4 months, p<0.0001) (see BioCentury, Oct. 31, 2011). Additional data from the trial showed that there was no difference between cabozantinib and placebo in OS, a secondary endpoint, at an interim analysis of 44% of the 217 events required. However, OS data are not yet mature. Cabozantinib did significantly improve ORR, also a secondary endpoint, vs. placebo (28% vs. 0%, p<0.0001) (see BioCentury, May 21). Exelixis has an SPA from FDA for the trial. ...