Adjuvant Nivolumab Approved in Europe for Completely Resected Stage IIB or IIC Melanoma
Source: OncLive, August 2023
The European Commission has approved single-agent nivolumab (Opdivo) for use in the adjuvant treatment of adult and adolescent patients aged 12 years or older who have stage IIB or IIC melanoma and who have undergone complete resection.
The regulatory decision is supported by findings from the phase 3 CheckMate-76K trial (NCT04099251). At a minimum follow-up of 7.8 months, the immunotherapy reduced the risk of disease recurrence or death by 58% compared with placebo in this population, with 12-month recurrence-free survival (RFS) rates of 89% (95% CI, 86%-92%) and 79% (95% CI, 74%-84%), respectively (HR, 0.42; 95% CI, 0.30-0.59; P < .0001). Notably, the RFS benefit derived with nivolumab spanned predefined subsets, including T category and disease stage.
“Patients with stage IIB or IIC melanoma are at a high risk of disease recurrence following surgery. This can be a very impactful event for patients,” Peter Mohr, MD, chief physician and head of the Skin Cancer Center, Buxtehude, in the Department of Dermatology, at Elbe-Kliniken, in Germany, stated in a press release. “This approval reinforces the benefit that nivolumab may offer when used after resection, potentially preventing the disease from recurring.”