Ipsen and Exelixis proclaims phase 3 CELESTIAL Trial results in patients with HCC

Ipsen and Exelixis declared results of Phase 3 CELESTIAL trial in  patients formerly treated with advanced heptacellular carcinoma. 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 (prespecified 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).

As far as the subgroup analysis of patients is concerned, prior therapy yielded results as follows, 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).

Alexandre Lebeaut, M.D., Executive Vice-President, R&D, Chief Scientific Officer, Ipsen, said: “ Patients diagnosed with advanced hepatocellular carcinoma urgently need new treatment options. The positive results of the pivotal phase 3 CELESTIAL trial are encouraging for both physicians and patients, and we have committed to file in the first half of 2018 a variation of the initial application to the EMA and other relevant regulatory agencies. ”

Reverse effects were witnessed in  16% patients receiving treatment in the cabozantinib arm and three percent of patients in the placebo arm leading to termination of the treatment.