For resected stage IIB and IIC melanoma, adjuvant pembrolizumab decreases the risk for disease recurrence or death compared with placebo, according to a study presented at the annual meeting of the European Society for Medical Oncology, held virtually from Sept. 16 to 21.

Jason Luke, M.D., from the UPMC Hillman Cancer Center in Pittsburgh, and colleagues examined pembrolizumab versus placebo in patients with resected American Joint Committee on Cancer-8 stage IIB or IIC melanoma with negative sentinel lymph node biopsy. A total of 976 patients were randomly assigned to either pembrolizumab or placebo (487 and 489 patients, respectively) for 17 cycles (up to one year).

The researchers found that pembrolizumab significantly prolonged regression-free survival (RFS) versus placebo at a median follow-up of 14.4 months (hazard ratio, 0.65). Recurrence occurred in 11.1 and 16.8 percent of patients in the pembrolizumab and placebo groups, respectively, with an almost halving of distant recurrent events in the pembrolizumab group (23 versus 38). The 12-month RFS rate was 90.5 versus 83.1 percent in the pembrolizumab and placebo groups, respectively. Grade ≥3 any-cause adverse events occurred in 25.9 and 17.1 percent of patients, respectively.

"Patients with stage IIb and IIc melanomas have a high level of risk for the disease coming back after surgery," Luke said in a statement. "This is a very important clinical trial as it shows that pembrolizumab reduces that risk. Based on these results, I believe that we should be offering patients in this situation the opportunity to get this treatment after surgery."

Several authors disclosed financial ties to Merck, which manufactures pembrolizumab and funded the study.

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