Phase 3 Data: Opdivo Reduced Risk of Recurrence or Death by 58% Versus Placebo in Patients with Completely Resected Stage IIB or IIC Melanoma
Bristol Myers Squibb shared results from the Phase 3 CheckMate -76K trial, in which Opdivo (nivolumab) as an adjuvant therapy demonstrated a statistically significant and clinically meaningful benefit in recurrence-free survival (RFS) versus placebo in patients with completely resected stage IIB or IIC melanoma. At a pre-specified interim analysis, the trial met its primary endpoint of recurrence-free survival (RFS); Opdivo reduced the risk of recurrence or death by 58% versus placebo (hazard ratio [HR] 0.42; 95% CI 0.30-0.59; p < 0.0001). Twelve-month RFS rates for Opdivo were 89% (95% CI: 86-92) versus 79% (95% CI: 74-84) for placebo. The RFS benefit was observed across predefined subgroups in the trial, including T category and disease stage. These results were presented as late-breaking data at the 2022 Society for Melanoma Research (SMR) Annual Meeting.
Twelve-month RFS rates by stage for patients who received Opdivo were 93% in stage IIB (versus 84% in placebo) and 84% in stage IIC (versus 72% with placebo).
The safety profile of Opdivo was consistent with that seen in previously reported studies and no new safety signals were observed at the time of the analysis. Grade 3/4 treatment-related adverse events (TRAEs) were 10% in the Opdivo arm and 2% in the placebo arm. TRAE-related discontinuation was 15% for those in the Opdivo arm and 3% for those in the placebo arm.
“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,” says 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, in a news 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 recurrence-free survival benefits and could be an important treatment option for this patient population.”
CheckMate -76K is part of Bristol Myers Squibb’s development program studying Opdivo and Opdivo-based combinations in earlier stages of cancer. The program currently spans seven different tumor types.
“These data add to our growing body of evidence supporting the clinical benefit of Opdivo for the treatment of melanoma, from the metastatic setting to earlier stages of cancer,” says Gina Fusaro, PhD, development program lead, melanoma, Bristol Myers Squibb. “We are continually seeking to advance our science to develop medicines that can help improve outcomes for people living with cancer.”