FDA Approves Adjuvant Nivolumab for Resected, Stage IIB/C Melanoma

On October 13, 2023, The US Food and Drug Administration (FDA) approved nivolumab in the adjuvant setting for patients 12 years and older with completely resected stage IIB/C melanoma. 

This approval was based on results from the double-blind, phase 3 CHECKMATE-76K trial. In this trial, 790 patients with completely resected stage IIB/C melanoma were enrolled. Enrollment required complete resection of the primary melanoma with negative margins, a negative sentinel lymph node within 12 weeks prior to randomization, and a ECOG performance status of 0 or 1. Patients with ocular, uveal, or mucosal melanoma, autoimmune disease, conditions requiring systemic treatment with corticosteroids (≥10 mg daily prednisone or equivalent) or other immunosuppressive agents, and patients with prior melanoma therapy except surgery were excluded from the trial. 

Patients were randomized on a 2-to-1 basis to receive either 480 mg intravenous nivolumab or placebo every 4 weeks for up to 1 year or until disease recurrence or unacceptable toxicity. The major efficacy outcome measure was recurrence-free survival (RFS) defined as the investigator-assessed time between randomization and first recurrence (local, regional, or distant metastasis), new primary melanoma, or death (from any cause), whichever occurred first. Assessments were conducted every 26 weeks during years 1 to 3 and every 52 weeks for up to 5 years. 

At the time of analysis, median RFS was not reached in either the nivolumab or the placebo arms (hazard ratio [HR], 0.42 [95% confidence interval [CI], 0.30 to 0.59]; P = < .0001). The most common adverse reactions occurring in ≥20% patients included fatigue, musculoskeletal pain, rash, diarrhea, and pruritus.

The recommended dose for adult patients weighing 40 kg or greater is 240 mg intravenous nivolumab every 2 weeks or 480 mg every 4 weeks until disease progression or unacceptable toxicity for up to 1 year. The recommended dose for pediatric patients weighing less than 40 kg is 3 mg/kg every 2 weeks or 6 mg/kg every 4 weeks until disease progression or unacceptable toxicity for up to 1 year. 

Source:

FDA approves nivolumab for adjuvant treatment of Stage IIB/C melanoma. US Food and Drug Administration. Published October 16, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-adjuvant-treatment-stage-iibc-melanoma