Adjuvant Nivolumab in Stage IIB/C Melanoma
Source: The Asco Post, March 2024
On October 13, 2023, nivolumab was approved for adjuvant treatment of completely resected stage IIB/C melanoma in patients aged 12 years and older.
Supporting Efficacy Data
Approval was based on findings in the double-blind CheckMate 76K trial (ClinicalTrials.gov identifier NCT04099251), in which 790 patients were randomly assigned on a 2:1 basis to receive nivolumab at 480 mg (n = 526) or placebo (n = 264) every 4 weeks for up to 1 year or until recurrence or unacceptable toxicity. Patients had to have complete resection of the primary melanoma with negative margins and a negative sentinel lymph node within 12 weeks prior to randomization.
Median recurrence-free survival was not reached in either the nivolumab group (95% confidence interval [CI] = 28.5 months to not reached) or placebo group (95% CI = 21.6 months to not reached). Recurrence-free survival events occurred in 13% vs 26% of patients (hazard ratio = 0.42, 95% CI = 0.30–0.59, P < .0001), respectively.