Dr Kirkwood on the Evolving Treatment of Resected Melanoma

John M. Kirkwood, MD, Distinguished Service Professor of Medicine, Sandra and Thomas Usher Professor of Medicine, Dermatology & Translational Science, coleader, Melanoma and Skin Cancer Program, Division of Hematology/Oncology, the University of Pittsburgh, discusses the significance of the FDA approval of adjuvant nivolumab (Opdivo) for patients with resected stage IIB or IIC melanoma.

In October 2023, the FDA approved the PD-1 inhibitor nivolumab for the adjuvant treatment of patients with completely resected stage IIB or IIC melanoma, based on findings from the global phase 3 CheckMate76K trial (NCT04099251). The addition of a new drug to the melanoma treatment paradigm is significant, Kirkwood says. In 1995, Kirkwood testified to the FDA’s Oncologic Drug Advisory Committee on behalf of adjuvant interferon alfa-2b for the treatment of patients with high-risk resected melanoma, as was investigated in the ECOG E1684 trial.

Stage IIB melanoma is deep primary disease, and stage IIC melanoma is deeper primary disease, Kirkwood states. It is important to develop treatments for patients with stage II melanoma because more patients present with stage IIB or IIC disease than with stage III or stage IV disease, according to Kirkwood. Furthermore, approximately half of patients who present with stage IIB or IIC melanoma have node-negative disease per sentinel node biopsy, and these patients’ risk of death is similar to that of patients with stage III melanoma, Kirkwood says.

Between 1995 and 2017, interferon alfa-2b was one of the only therapies available for patients with node-positive or deep primary node–negative disease, and was a difficult-to-tolerate therapy, Kirkwood explains. Additonally, this agent elicited minimal reductions in relapse and death and had an intensive administration schedule, Kirkwood notes.

Conversely, adjuvant nivolumab, which is administered at a less frequent dosing schedule than interferon alfa-2b, is effective at reducing relapses, is well tolerated, and has thus become the new standard of care for patients with resected stage IIB or IIC melanoma, Kirkwood concludes.