The US Food and Drug Administration (FDA) has revealed that Opdivo (nivolumab) in combination with Yervoy (ipilimumab) has been approved to treat hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib (sold as Nexavar by Bayer).

The US federal department says that it has given the combo Accelerated Approval based on overall response rate and duration of response seen in the Opdivo/Yervoy cohort of the Phase I/II CheckMate -040 trial.

In the trial, in the cohort of HCC patients previously treated with sorafenib, after a minimum follow up of 28 months 33% of patients responded to treatment with Opdivo/Yervoy, 8% had a complete response and 24% had a partial response.

The decision means that the combo is the only dual immunotherapy approved by the FDA in this setting.

HCC is an “aggressive disease in need of different treatment approaches,” commented Anthony El-Khoueiry, lead investigator and associate professor of clinical medicine and phase I program director at the Keck School of Medicine. “The overall response rate observed in the Opdivo/Yervoy cohort of the CheckMate -040 trial underscores the potential of this dual immunotherapy as a possible treatment option for patients.”

Last month Bristol-Myers Squibb also announced that the combo demonstrated superior overall survival, complete response rates and objective response rates at 42 months in a trial of intermediate/poor risk renal cell carcinoma (RCC) patients.

Currently, Opdivo and Yervoy are licensed together in the UK as a first-line treatment for adult patients with intermediate- and poor-prognostic risk advanced RCC only, but the “clinically meaningful results continue to demonstrate the potential of nivolumab plus ipilimumab to improve the long-term survival of intermediate/poor risk renal cell carcinoma patients,” said professor Thomas Powles, director of Barts Cancer Centre.