Adjuvant Nivolumab Demonstrates Reduced Risk of Death or Recurrence Vs Placebo in Stage IIB/C Melanoma

Nivolumab (Opdivo) produced a statistically significant improvement in recurrence-free survival (RFS) as an adjuvant treatment for patients with completely resected stage IIB or IIC melanoma compared with placebo, according to a press release on the data from the phase 3 CheckMate-76K trial (NCT04099251),

Data from the trial were presented at the 2022 Society for Melanoma Research (SMR) Annual Meeting. In the trial, nivolumab yielded a 58% reduction in risk of death or disease recurrence compared with placebo (HR, 0.42; 95% CI, 0.30-0.59; P <.0001). The 12-month RFS rates were 89% (95% CI, 86%-92%) for those receiving nivolumab and 79% (95% CI, 74%-84%) among those treated with placebo. The RFS benefit of nivolumab was observed across predefined patient subgroups, with patients improving regardless of disease stage and T category. The 12-month RFS rate in the stage IIB group was 93% with nivolumab vs 84% with placebo. In the stage IIC group, nivolumab produced an RFS rate of 84% vs 72% with placebo.

“Within five years after surgery, one third of stage IIB and one half of IIC patients see their cancer return. Helping reduce that risk remains a need to be addressed when it comes to treating melanoma,” Georgina Long, AO, MD, PhD, co-medical director at the Melanoma Institute Australia (MIA) and chair of melanoma medical oncology and translational research at the MIA, University of Sydney and Royal North Shore and Mater Hospitals, said in the press release. “The data from CheckMate-76K show that treating with nivolumab in the adjuvant setting for [patients with] stage IIB and IIC melanoma has yielded significant recurrence-free survival benefits and could be an important treatment option for this patient population.”

The randomized, double-blind phase 3 CheckMate-76K trial was designed to assess the benefit of adjuvant nivolumab compared with placebo. A total of 790 patients with completely resected stage IIB or IIC melanoma enrolled on the study. Patients were randomly assigned to receive either 480 mg of adjuvant melanoma every 4 weeks for up to 12 months or matched placebo.

The primary end point of the trial was RFS. Secondary end points include overall survival for up to 7 years, distant metastases-free survival, the occurrence and severity of adverse effects (AEs) per NCI CTCAE v5 criteria, and investigator-assessed progression-free survival on next line of therapy.

Patients 12 years and older who have been diagnosed with histologically confirmed, resected stage IIB/C melanoma were eligible to participate in the trial. Additional inclusion criteria included having a negative sentinel lymph node biopsy, no previous treatment for melanoma, and an ECOG performance status of 1 or 2.

The safety profile of nivolumab in the Checkmate-76K trial was consistent with previously reported studies, and no new safety signals were reported in the analysis. Grade 3/4 treatment-related AEs (TRAEs) were observed among 10% of those in the nivolumab arm and 2% of those receiving placebo. Treatment discontinuations related to TRAEs were reported in 15% of patients in the nivolumab arm vs 3% of those in the placebo cohort.

Reference

Bristol Myers Squibb presents data from CheckMate -76k showing Opdivo (nivolumab) reduced the risk of recurrence or death by 58% versus placebo in patients with completely resected stage IIB or IIC melanoma. News release. Bristol Myers Squibb. October 19, 2022. Accessed October 21, 2022. https://bit.ly/3VKfLMH