Efficacy
At the data cutoff, 12.5% of patients in the nivolumab group and 26.1% in the placebo group had experienced recurrence or death, with a hazard ratio (HR) for RFS of 0.42 (95% CI: 0.30–0.59; P < 0.0001). The 12-month RFS rates were 89.0% for nivolumab versus 79.4% for placebo. Nivolumab also showed a significant improvement in DMFS, with an HR of 0.47 (95% CI: 0.30–0.72).
Safety
The safety profile of nivolumab was consistent with previous reports, with any-grade treatment-related adverse events occurring in 82.6% of patients in the nivolumab group and 53.8% in the placebo group. Grade 3 or 4 events were observed in 10.3% of nivolumab-treated patients and 2.3% of placebo-treated patients. The most common adverse events included rash, diarrhea/colitis, and hepatitis.
Conclusion
Adjuvant nivolumab significantly improves RFS and DMFS in patients with resected stage IIB/C melanoma, demonstrating a clinically meaningful benefit across all pre-specified subgroups. The safety profile is manageable, supporting the use of nivolumab as an effective adjuvant treatment option for this patient population.
