Bristol-Myers Squibb (BMS) has announced the initial findings of the ongoing Phase I/II CheckMate-040 clinical trial that is assessing an Opdivo (nivolumab) and Yervoy (ipilimumab) combination in advanced hepatocellular carcinoma (HCC).
The open-label, multi-cohort trial involves patients that were previously treated with sorafenib.
Data has shown that the blinded independent central review (BICR) objective response rate (ORR) was 31% per RECIST v1.1 criteria, with a minimum follow-up of 28 months.
The median duration of response (DoR) was observed to be 17.5 months at the time of data cutoff.
During the CheckMate-040 trial, subjects were randomised to three different dosing schedules of Opdivo plus Yervoy. Responses were reported in all three treatment arms.
Participants that received 1mg/kg Opdivo and 3mg/kg Yervoy every three weeks for four cycles had the longest median overall survival (OS) at 22.8 months and a 44% 30-month OS rate.
Across the Opdivo plus Yervoy cohort, 5% of subjects achieved a complete response (CR), while 26% experienced a partial response (PR). The safety profile was found to be acceptable.
Bristol-Myers Squibb gastrointestinal cancers development lead Ian Waxman said: “Opdivo has been an important treatment option for patients with advanced HCC since 2017, when it became the first immuno-oncology agent FDA approved for this aggressive cancer.
“We are encouraged by the efficacy observed with the Opdivo plus Yervoy combination in this cohort of CheckMate-040 and are grateful to the patients and investigators for their participation in this study, without whom this progress would not be possible.”
The Phase I/II trial is being conducted to study Opdivo as a single agent or combination therapy in advanced HCC patients with and without chronic viral hepatitis that are treatment-naïve, intolerant, or progressed during sorafenib treatment.