Opdivo Approved for Patients With Completely Resected Stage IIB/C Melanoma

The Food and Drug Administration (FDA) has expanded the approval of Opdivo^® (nivolumab) to include adjuvant treatment of patients 12 years of age and older with completely resected stage IIB or stage IIC melanoma. Previously, Opdivo had been approved for the adjuvant treatment of patients with melanoma with lymph node involvement or metastatic disease who had undergone complete resection.

The expanded approval was based on data from the randomized, double-blind phase 3 CheckMate -76K trial (ClinicalTrials.gov Identifier: NCT04099251), which compared the efficacy and safety of nivolumab, a programmed death receptor-1 (PD-1)-blocking antibody, to placebo as monotherapy in the adjuvant setting in 790 patients with completely resected stage IIB/C melanoma. Patients were randomly assigned to receive either nivolumab 480mg or placebo by intravenous infusion every 4 weeks for up to 1 year or until disease recurrence or unacceptable toxicity. 

The primary endpoint was recurrence free survival (RFS), defined as the time between the date of randomization and the date of first recurrence (local, regional, or distant metastasis), new primary melanoma, or death, from any cause, whichever occurred first and as assessed by the investigator.

Findings showed that treatment with nivolumab reduced the risk of recurrence or death by 58% compared with placebo (hazard ratio [HR], 0.42; 95% CI, 0.30-0.59; P <.0001). Median RFS was not reached in either the nivolumab arm (95% CI, 28.5, not reached [NR]) or in the placebo arm (95% CI, 21.6, NR). The most common adverse reactions reported with treatment were fatigue, musculoskeletal pain, rash, diarrhea, and pruritus. 

“Stage IIB and IIC melanoma patients may still face the threat of disease recurrence, despite the benefit of surgery, which can impact outcomes,” said Catherine Owen, senior vice president and general manager, US Cardiovascular, Immunology and Oncology at Bristol Myers Squibb. “This approval builds on our existing adjuvant indication in completely resected stage III or IV disease and now provides eligible patients with completely resected stage IIB or IIC melanoma an additional treatment option which may help prevent recurrence.”

This article originally appeared on MPR