A late-stage trial assessing Ipsen and Exelixis’ Cabometyx in advanced liver cancer has been halted early after a significant improvement in overall survival was observed.
Results of the Phase III CELESTIAL trial showed a median overall survival of 10.2 months in patients taking Cabometyx (cabozantinib) and 8.0 months for those given a placebo.
The trial involved patients with advanced hepatocellular carcinoma (HCC) who had received previous treatment with sorafenib and experienced disease progression after one-two prior systemic treatments.
The study also met all key secondary endpoints, including a statistically significant increase in median progression-free survival (PFS; 5.2 months versus 1.9 months) and objective response rates (4 percent versus 0.4 percent).
“These data will form the basis of our licence submission, bringing us one step closer to making this positive new treatment available to patients in the UK & Ireland,” said Ewan McDowall, general manager, Ipsen UK & Ireland.
The drug is currently indicated in the UK for the treatment of advanced RCC in adults following prior VEGF-targeted therapy.