Opdivo Improves Time to Disease Recurrence in Stage 2B and 2C Skin Cancer

Treatment with Opdivo (nivolumab) after surgery improved survival compared with placebo in patients with stage 2B or 2C melanoma, a type of skin cancer, that was completely resected, according to findings from the phase 3 CheckMate-76K clinical trial.

In particular, Opdivo improved recurrence-free survival, which is the time from treatment until the disease recurs or death. Patients with stage 2B or 2C melanoma who underwent complete resection have an increased risk for disease recurrence after the procedure, according to a press release published by Bristol Myers Squibb, the drug’s manufacturer.

“Within five years after surgery, one third of stage 2B and one half of 2C patients see their cancer return,” Dr. Georgina Long, co-medical director of Melanoma Institute Australia (MIA) and chair of melanoma medical oncology and translational research at MIA, The University of Sydney, and Royal North Shore and Mater Hospitals, said in the release. “Helping reduce that risk remains a need to be addressed when it comes to treating melanoma.”

Findings from an analysis of the trial showed that Opdivo reduced the risk of recurrence or death by 58% versus placebo. In addition, 89% of patients treated with Opdivo were still alive and without recurrence 12 months after treatment compared to 79% of those given placebo, according to the release.

Specifically, for patients with stage 2B disease, the relapse-free survival rate at 12 months was 93% versus 84% with placebo. In the stage 2C group, 12-month relapse-free survival rates were 84% and 72% in the Opdivo and placebo groups, respectively.

“The data from CheckMate-76K show that treating with (Opdivo) in the adjuvant setting for stage 2B and 2C melanoma patients has yielded significant recurrence-free survival benefits and could be an important treatment option for this patient population,” Long said.

Of note, Opdivo’s safety profile from the CheckMate-76K trial was similar to that seen in other trials of the immunotherapy agent, with no new side effects reported. Severe treatment-related side effects occurred in 10% of patients in the Opdivo group compared with 2% of those in the placebo group.

Fifteen percent of patients in the Opdivo group had to stop treatment due to side effects versus 3% in the placebo group.

In the ongoing CheckMate-76 trial, researchers are evaluating the effectiveness of Opdivo administered every four weeks for up to 12 months compared with placebo in 790 patients with completely resected stage 2B or 2C melanoma, according to the release.

The main focus of the trial is recurrence-free survival, with secondary goals including distant metastases-free survival (the time from treatment until the cancer spreads from the original location to distant organs or lymph nodes), overall survival (the length of time from treatment when a patient with cancer is alive), the safety profile of the treatment and progression-free survival (the time during and after treatment when a patient lives with cancer without disease worsening) on next-line therapy.

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