Nivolumab + ipilimumab combo for HCCJanuary 6, 2020
The US FDA has granted Breakthrough Therapy Designation for nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the treatment of patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib, BMS said.
The application is based on data from the nivolumab plus ipilimumab cohort of the phase 1/2 CheckMate -040 study evaluating the immuno-oncology combination in patients with advanced HCC previously treated with sorafenib.
CheckMate -040 is an ongoing phase 1/2, open-label, multi-cohort study investigating nivolumab or nivolumab-based combinations in patients with advanced HCC with and without chronic viral hepatitis who are naïve, intolerant to or who have progressed during sorafenib therapy.
Nivolumab is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to harness the body’s own immune system to help restore anti-tumour immune response.