Positive Phase III CELESTIAL study of Cabometyx in hepatocellular carcinoma (liver cancer)- Exelixis Inc.+ Ipsen.

Exelixis, Inc. and Ipsen announced detailed results of the pivotal phase III CELESTIAL trial of cabozantinib in patients with previously treated advanced hepatocellular carcinoma (HCC), which will be presented in a late-breaking oral session at the 2018 ASCO-GI Symposium being held in San Francisco, January 18-20, 2018.

In CELESTIAL, cabozantinib provided a statistically significant and clinically meaningful improvement versus placebo in overall survival (OS), the trial�s primary endpoint, at the planned second interim analysis (pre-specified critical p-value ? 0.021) for the population of second- and third-line patients enrolled in this study. Median OS was 10.2 months with cabozantinib versus 8.0 months with placebo (HR 0.76, 95 percent CI 0.63-0.92; p=0.0049). Median progression-free survival (PFS) was more than doubled, at 5.2 months with cabozantinib and 1.9 months with placebo (HR 0.44, 95 percent CI 0.36-0.52; p<0.0001). objective response rates per recist 1.1 were 4 percent with cabozantinib and 0.4 percent with placebo p="0.0086)." disease control partial response or stable disease was achieved by 64 percent of the cabozantinib group compared with 33 percent of the placebo group.>

In a subgroup analysis of patients whose only prior therapy for advanced HCC was sorafenib (70 percent of patients in the study), median OS was 11.3 months with cabozantinib versus 7.2 months with placebo (HR 0.70, 95 percent CI 0.55-0.88). Median PFS in the subgroup was 5.5 months with cabozantinib versus 1.9 months with placebo (HR 0.40, 95 percent CI 0.32-0.50). Adverse events were consistent with the known safety profile of cabozantinib.