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.
"We are proud to bring the potential for clinically meaningful responses with Immuno-Oncology therapy to these advanced-stage HCC patients, who have had limited treatment options for years," said Chris Boerner, president of the US commercial division at Bristol-Myers Squibb.
"Unfortunately, the majority of HCC patients are diagnosed with advanced-stage disease and are not candidates for potentially curative surgical interventions," said Adrian M. Di Bisceglie, MD, co-director, Saint Louis University Liver Center, and chief of hepatology, Saint Louis University School of Medicine, Missouri. "More options are needed for advanced-stage HCC patients who have failed prior systemic therapy," he commented in the company press release.
Nivolumab has been associated with immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, skin adverse reactions, encephalitis, infusion reactions, embryo-fetal toxicity, and other adverse reactions.
Specifically in the CheckMate-040 study, immune-mediated hepatitis requiring systemic corticosteroids occurred in 5% of patients (8 of 154). Serious adverse reactions occurred in 49% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pyrexia, ascites, back pain, general physical health deterioration, abdominal pain, and pneumonia. The most common adverse reactions (≥20%) in patients receiving nivolumab (n = 154) were fatigue (38%), musculoskeletal pain (36%), abdominal pain (34%), pruritus (27%), diarrhea (27%), rash (26%), cough (23%), and decreased appetite (22%). The drug was discontinued because of adverse reactions in 11% of patients, and 32% of patients had a dose delay for an adverse reaction.
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