Evaluating the safety and effectiveness of nivolumab and relatlimab before surgery in patients with resectable melanoma

The study evaluated the safety and effectiveness of relatlimab (Opdualag) and nivolumab (Opdivo) combination therapy before surgery in patients with stages III and IV resectable melanoma. The study concluded that the relatlimab and nivolumab combination was safe and effective in these patients.

Melanoma is an aggressive form of skin cancer. It has a high tendency to spread to other parts of the body (metastasis). The standard treatment for advanced melanoma is a combination of immunotherapy, chemotherapy, surgical removal of tumors, and radiation therapy. In patients with more advanced-stage melanoma, the risk of recurrence or metastasis is higher.

To avoid this, patients can be given additional immunotherapy before the start of treatment (known as neoadjuvant therapy) to shrink the tumor size and also after the surgery (known as adjuvant treatment) to kill any remaining cancer cells. Immunotherapy uses the body’s own system to fight against cancer cells. Cancer cells turn off the immune system by binding to the specific proteins present on the cell surface. Nivolumab and relatlimab are checkpoint inhibitors that block those interactions and enhance the immune system's ability to target and destroy cancer cells.

Previous studies have shown that combining nivolumab and relatlimab improves the survival of patients with advanced melanoma, unfit for surgery. However, the safety and effectiveness of relatlimab and nivolumab before surgery in patients with resectable melanoma are still under investigation. 

This study involved 30 patients with stage III, and IV resectable melanoma. All patients received two doses of nivolumab plus relatlimab before surgery and another ten doses of the same combination after surgery. The average follow-up period was 24.4 months.

57% of patients showed a complete absence of invasive cancer (also known as pathologic complete response; pCR) after treatment and the overall response rate was 70%.

Overall, 97% of the patients who had surgery were alive without relapse at 1 year and 82% after 2 years. 100% of the patients who had a pCR were alive without relapse after 1 year and 91% at 2 years. In patients who did not have a pCR, 92% were alive without relapse after 1 year and 69% after 2 years.  

Overall, 93% of all patients were alive after 1 year and 88% after 2 years. 

No serious immune-related adverse effects were reported during the 8 weeks of neoadjuvant therapy.

The study showed that relatlimab and nivolumab combination therapy in a neoadjuvant setting was well tolerated, safe, and effective in patients with resectable melanoma.

The study was conducted on a small number of patients and the results were preliminary. Also, there was no comparison group. Larger, randomized trials are needed to validate these findings.