New hope: Nivolumab Approved for metastatic and unresectable Liver Cancer.

Nivolumab (Opdivo, Bristol-Myers Squibb) has been approved by the US Food and Drug Administration (FDA) for use in the treatment of hepatocellular carcinoma (HCC) in patients who have previously been treated with sorafenib (Nexavar, Bayer).
The immunotherapy is already approved for use in many different cancer types, including melanoma, lung and kidney cancer, and Hodgkin's lymphoma.
This latest indication is an accelerated approval based on tumor response rates and durability of response, as seen in the CheckMate-040 trial, a single-arm phase1/2 trial.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials, the company noted.
The trial was conducted in 154 patients with HCC who had progressed on, or were intolerant of, sorafenib.  All patients received nivolumab 3 mg/kg administered intravenously every 2 weeks.

The overall response rate was 14.3% (22 of 154 patients), with 3 patients (1.9%) showing a complete response and 19 patients (12.3%) a partial response. The duration of the responses ranged from 3.2 to 38.2+ months; 91% of those patients had responses of 6 months or longer and 55% had responses of 12 months or longer, the manufacturer noted in a press release.