Immune Checkpoint Therapy Approved for Non-metastatic Melanoma After Surgery

The FDA approved nivolumab for some patients with melanoma whose tumor was completely removed through surgery and has not spread.

The U.S. Food and Drug Administration (FDA) has approved the checkpoint inhibitor nivolumab (Opdivo) for the adjuvant treatment of stage IIB/C melanoma that has not spread and has been completely resected. Adjuvant treatment is given after surgery to prevent the cancer from coming back. 

Immune checkpoint inhibitors are immunotherapy drugs that boost the body’s anticancer immune response by blocking the activity of immune checkpoint proteins. These are present on immune cells and dampen their cancer-killing function. Nivolumab inhibits a checkpoint protein called PD-1.  

A dermatologist examining a patient's skin with a microscope to look for signs of melanoma.

Nivolumab was first approved in 2014 to treat advanced melanoma that cannot be removed by surgery and is no longer responding to other therapies. The approval was extended in 2017 to include adjuvant treatment for patients with metastatic melanoma whose tumor has been completely resected. The new approval further extends nivolumab use to earlier stages of disease as an adjuvant treatment for patients with melanoma that has been completely resected and has not metastasized. 

The approval was based on the results of CHECKMATE-76K, a randomized, double-blind, phase III clinical trial that enrolled 790 patients with stage IIB/C melanoma that had been completely resected. Patients were randomly assigned (2:1) to receive nivolumab or placebo every four weeks for up to one year or until disease recurrence or unacceptable toxicity. Patients who had received prior systemic melanoma therapy were excluded.  

Patients who received nivolumab had their risk of recurrence, new primary melanoma, or death reduced by 58% compared to those in the placebo arm.  

Melanoma is a rare but aggressive form of skin cancer. According to federal statistics, more than 97,600 melanoma cases will be diagnosed and 7,990 people will die of the disease in the United States in 2023.   

The FDA decision was rendered on October 13, 2023.