Adjuvant Nivolumab Reduces Risk of Recurrence or Death by 58% in Select Stage IIB or IIC Melanoma

Adjuvant treatment with nivolumab (Opdivo) resulted in a statistically significant and clinically meaningful improvement in recurrence-free survival (RFS) over placebo in patients with completely resected stage IIB or IIC melanoma, meeting the primary end point of the phase 3 CheckMate-76K trial (NCT04099251).¹

Data presented during the 2022 Society for Melanoma Annual Meeting showed that at the time of a prespecified interim analysis, adjuvant nivolumab resulted in a 58% reduction in the risk of disease recurrence or death compared with placebo (HR, 0.42; 95% CI, 0.30-0.59; P < .0001). The 12-month RFS rate with the immunotherapy was 89% (95% CI, 86%-92%) vs 79% (95% CI, 74%-84%) with placebo.

Notably, the RFS benefit achieved with nivolumab was noted across predefined subsets, such as T category and disease stage. Specifically, in those with stage IIB disease, the 12-month RFS rate achieved with nivolumab was 93% vs 84% with placebo; in the population of patients with stage IIC disease, these rates were 84% vs 72%, respectively.

“Within 5 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,” Professor Georgina Long, AO, MD, PhD, co-medical director of Melanoma Institute Australia (MIA) and chair of melanoma medical oncology and translational research at MIA, The University of Sydney, and Royal North Shore and Mater Hospitals, stated in the press release. “The data from CheckMate-76K show that treating with nivolumab in the adjuvant setting for stage IIB and IIC melanoma patients has yielded significant RFS benefits and could be an important treatment option for this patient population.”

The double-blind study enrolled patients who were at least 12 years of age and who had a negative sentinel lymph node biopsy and who were diagnosed with histologically confirmed, resected, stage IIB/C cutaneous melanoma.² To be eligible for enrollment, patients needed to have an ECOG performance status of 0. Patients could not have previously received treatment for their disease.

If they had a history of ocular or mucosal melanoma, were pregnant or nursing, had active known or suspected autoimmune disease, or a known history of allergy or hypersensitivity to study drug components, they were excluded. Patients also could not have received prior treatment with an anti–PD-1/PD-L1, anti-CD137, anti–CTLA-4 antibody, or agents that target interleukin-2 pathways, T-cell stimulators, or checkpoint pathways.

RFS served as the primary end point of the trial, and key secondary end points comprised overall survival, distant metastasis-free survival, progression-free survival on next-line thrapy, and safety.

Data presented during the meeting showed that in terms of safety, the toxicity profile of the immunotherapy was consistent with what has previously been reported. Notably, no new safety signals were reported at the time of the analysis.

Treatment-related adverse effects (TRAEs) that were grade 3 or higher occurred in 10% of those in the investigative arm and 2% of those in the control arm. Moreover, 15% of those in the nivolumab arm and 3% of those in the placebo arm experienced TRAEs that resulted in treatment discontinuation.

References

1. 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 19, 2022. https://bit.ly/3F19lD3
2. Effectiveness study of nivolumab compared to placebo in prevention of recurrent melanoma after complete resection of stage IIB/C melanoma (CheckMate76K). ClinicalTrials.gov. Updated September 2, 2022. Accessed October 19, 2022. https://clinicaltrials.gov/ct2/show/NCT04099251