French pharmaceutical company Ipsen has announced that The New England Journal of Medicine has published the results of a Phase 3 clinical trial of liver cancer drug Cabometyx (cabozantinib).
The data demonstrates that cabozantinib provides a statistically significant and clinically meaningful improvement in overall survival in cases of hepatocellular carcinoma (HCC), the second leading cause of cancer deaths worldwide. With approximately 800,000 new cases of HCC diagnosed each year, the deadly cancer is the most common form of liver cancer in adults across the globe.
As expanded upon by Dr Lorenza Rimassa, Deputy Director, Medical Oncology Unit, Humanitas Cancer Center Humanitas Research Hospital: “Patients with advanced HCC have a very poor prognosis and limited treatment options. Given the worldwide prevalence of advanced HCC, there is a continued urgency to bring new treatment options to these patients. The clinically significant benefits in both overall survival and progression-free survival shown in the CELESTIAL trial, in patients previously treated with up to two treatment lines, suggest that cabozantinib could become (when approved) an important addition to the treatment landscape for this patient population.”
The orally applied cabozantinib tablets provided a median overall survival rate of 10.2 months in comparison with a rate of 8.0 months for those patients given a placebo. In a subgroup analysis of patients whose only prior therapy for advanced HCC had been sorafenib the median OS was 11.3 months in comparison with a rate of 7.2 months for those given a placebo. Adverse events were consistent with the drug’s known safety profile.
As noted by Dr Ghassan K Abou-Alfa, at the Memorial Sloan Kettering Cancer Centre: “Patients with this form of advanced liver cancer have very limited treatment options once their disease progresses following treatment with sorafenib. These results suggest that, if approved, cabozantinib could become an important addition to the treatment landscape that may help slow disease progression and, critically, improve survival for these patients.”