Adjuvant Nivolumab Receives CHMP Recommendation for Completely Resected Stage IIB/C Melanoma
Source: OncLive, July 2023
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of nivolumab (Opdivo) monotherapy for the adjuvant treatment of patients at least 12 years of age with completely resected stage IIB or IIC melanoma.
The positive opinion is supported by data from the phase 3 CheckMate76K trial (NCT04099251), which showed that nivolumab reduced the risk of recurrence or death by 58% compared with placebo (HR, 0.42; 95% C, 0.30-0.59; P < .0001). The 12-month recurrence-free survival (RFS) rates were 89% (95% CI, 86%-92%) for nivolumab vs 79% (95% CI, 74%-84%) for placebo.
“Many patients with stage IIB or stage IIC melanoma face the difficult reality of disease recurrence within 5 years of surgery,” Gina Fusaro, PhD, vice president, global program lead, Bristol Myers Squibb, stated in a news release.1 “In the data from the CheckMate76K trial, [nivolumab] was shown to significantly reduce the risk of disease recurrence for these patients. The CHMP’s recommendation brings us closer to potentially providing [nivolumab] for use in treating additional earlier stages of melanoma in the adjuvant setting, addressing an unmet need for patients in the European Union.”