FDA Agrees to Review Opdivo for Post-Surgical Melanoma Treatment

The Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application to treat Opdivo (nivolumab) in patients with stage 2B or 2C melanoma that has been completely resected (surgically removed), according to Bristol Myers Squibb, the manufacturer of the immunotherapy agent.

A supplemental Biologics License Application is used to request permission to distribute a drug across state lines in the United States. By accepting the application, the FDA also set a goal date of Oct. 13, 2023 to decide on Opdivo’s approval in this indication.

The FDA’s decision was based on findings from the randomized, phase 3 CheckMate-76K trial, which compared 12 months of treatment with Opdivo versus placebo in patients with completely resected stage 2B/C melanoma.

Study findings showed that at the 12-month mark, 89% of patients in the Opdivo group did not experience disease recurrence, compared with 79% of patients in the placebo group. In particular, for patients with stage 2B disease, the 12-month relapse-free survival rate was 93% in the Opdivo group and 84% in the placebo group. For patients with stage 2C melanoma, 12-month relapse-free survival rates were 84% and 72% in the Opdivo and placebo groups, respectively.

“Melanoma can be a devastating diagnosis, and patients with stage 2B or 2C melanoma tend to be at high risk of disease recurrence. Approximately one third of stage 2B and half of stage 2C patients experience recurrence within five years after surgery,” said Gina Fusaro, vice president, development program lead, at Bristol Myers Squibb, said in a press release.

Opdivo is an immunotherapy agent that works by blocking PD-1, a protein involved in the regulation of the immune system that sometimes tells T-cells not to attack cancer cells. By stopping PD-1 activity, patients’ immune system can better find and kill cancer.

Additional data from CheckMate-76K showed that there were no new side effects observed in patients being treated with Opdivo that have not been seen with the drug in prior studies. Ten percent of patients in the Opdivo group experienced moderate to severe side effects, compared to 2% in the placebo group. A total of 15% of patients on Opdivo and 3% on placebo stopped treatment due to side effects.

“The data from the CheckMate -76K trial demonstrate the benefit that Opdivo can have for patients with this earlier stage of cancer. We look forward to working with the U.S. Food and Drug Administration and the European Medicines Agency to potentially offer a treatment option to patients with stage 2B or 2C melanoma that could help prevent recurrence,” Fusaro said.

The trial is still ongoing, and in addition to relapse-free survival, investigators also plan on analyzing overall survival (time from treatment until death of any cause), side effect occurrence and severity, distant metastasis-free survival (time from treatment until the presence of disease far away from the original site) and outcomes on the next line of therapy.

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