Ipsen, Exelixis promising with their treatment for patients with advanced liver cancerJanuary 17, 2018
Ipsen and Exelixis on Tuesday said that their phase 3 study of study of cabozantinib in patients with advanced liver cancer, hepatocellular carcinoma (HCC) showed clear improvement versus palcebo.
The study details will be presented on a symposium in San Francisco from 18-20 January.
Disease control 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.
“Patients with advanced hepatocellular carcinoma often have a poor prognosis and limited treatment options following prior systemic therapy,” said Dr. Abou-Alfa. “The clinically significant benefits in both overall survival and progression-free survival shown in the CELESTIAL trial suggest that, if approved, cabozantinib could become an important addition to the treatment landscape for these patients.”
Gisela Schwab, President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis, said: “We are excited by the potential benefit cabozantinib may offer to patients with previously treated HCC. Given the worldwide prevalence of advanced hepatocellular carcinoma, there is a continued urgency to bring new treatment options to this patient population. We look forward to submitting our supplemental New Drug Application to the FDA for cabozantinib in the first quarter of 2018, and to further advancing our mission to help cancer patients recover stronger and live longer.”
Alexandre Lebeaut, 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.”