Immunotherapy Nivolumab Receives FDA Approval for Liver Cancer Treatment

On 22 September 2017, the United States Food and Drug Administration, FDA, granted accelerated approval to the cancer immunotherapy nivolumab (brand name Opdivo) for liver cancer (hepatocellular carcinoma) patients previously treated with sorafenib.

Liver cancerhas few treatment options, particularly in advanced stages, and chemotherapy has limited effectiveness. Until 2017, advanced or inoperable liver cancer had only one approved treatment: sorafenib (brand name Nexavar), an oral small-molecule targeted drug. When patients stopped responding or could not continue because of side effects, no effective second-line treatment was available. Earlier this year, on 2 May, regorafenib (brand name Stivarga) was approved for second-line liver cancer treatment; now the cancer immunotherapy nivolumab follows.

Details of the Study Leading to Nivolumab Approval

Approval was based on the multicenter, open-label study including liver cancer patients with progression on sorafenib or intolerance to it and Child-Pugh A cirrhosis, 154 patients in total, the CHECKMATE-040 clinical trialresults.

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Patients received nivolumab every 2 weeks by intravenous infusion at 3 mg / kg. Tumors shrank significantly in 19 patients (% 14.3); 3 patients achieved complete response. Response duration ranged from 3.2 to 38.2 months; % 91 responded for 6 months or longer, and % 55 for 12 months or longer.

Common side effects occurring in more than % 20 of nivolumab recipients included weakness, allergic rash, musculoskeletal pain, diarrhea, nausea, cough, shortness of breath (dyspnea), constipation, decreased appetite, lower back pain, joint pain (arthralgia), upper respiratory infection and fever. As expected, elevated transaminases (ALT and AST) and bilirubin were more frequent side effects in liver cancer patients in CHECKMATE-040.

For liver cancer, the recommended nivolumab dosefor liver cancer is every 2 weeks, 240 mg.

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