Nivolumab, a treatment used for hepatocellular carcinoma (HCC), has been approved by the FDA for patients who have treated previously with sorafenib. The immunotherapy has already been approved in a number of different cancer types, such as melanoma, kidney and lung cancer and Hodgkin’s lymphoma. The most recent signal is an accelerated approval based on the response rate of tumor and durability of response as viewed in the CheckMate-040 trial and single-arm phase ½ trial.
We continue to see approval for any indication that could depend on verification and description of the clinical benefits in the clinical trials, the company reported.
The trial was monitored in 154 patients with HCC who had progressed on, or were biased of, sorafenib. All patients were administered nivolumab 3 mg/kg monitored intravenously every 14 days.
The broad response rate was 22 of the 154 patients, with 1.9% displaying a complete response and 19 patients a partial response. The period of the responses varied from 3 to 38 months; 91% of those patients had responses of 6 months or longer and 55% had responses of 12 months or longer, according to the manufacturer.
“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,” stated 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,” quoted 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 connected with immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, nephritis & renal dysfunction, skin adverse reactions, encephalitis, infusion reactions, embryo-fetal toxicity, and a number of other side affects.
Precisely in the CheckMate-040 study, immune-mediated hepatitis needing systemic corticosteroids happened in 5% of patients (8 of 154). Severe adverse reactions took place in 49% of patients. The most prevalent serious side affects reported in at least 2% of patients were pyrexia, ascites, back pain, general physical health deterioration, abdominal pain, and pneumonia.