Nivolumab significantly prolongs recurrence-free survival in resected stage II melanoma
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Nivolumab conferred a statistically significant and clinically meaningful improvement in recurrence-free survival vs. placebo among patients with completely resected stage IIB or IIC melanoma, according to the agent’s manufacturer.
Results of a pre-specified interim analysis of the randomized phase 3 CheckMate -76K trial, — presented at 2022 Society for Melanoma Research Annual Meeting this week — showed a 58% reduction in the risk for recurrence or death with nivolumab (Opdivo, Bristol Myers Squibb), the company announced in press release. In addition, the PD-1 immune checkpoint inhibitor exhibited a safety profile consistent with prior studies, with no new safety signals.
“Within 5 years after surgery, one-third of stage IIB and one-half of IIC patients see their cancer return,” Georgina V. Long, AO, MD, PhD, co-medical director of Melanoma Institute Australia and chair of melanoma medical oncology and translational research at the institute and Royal North Shore Hospital at The University of Sydney, said in the press release. “[Nivolumab] could be an important treatment option for this patient population.”
The trial includes 790 patients with completely resected stage IIB or IIC melanoma randomly assigned to nivolumab dosed at 480 mg every 4 weeks for up to 12 months or placebo. Recurrence-free survival (RFS) serves as the primary endpoint. Secondary endpoints include OS, distant metastases-free survival, PFS on next-line therapy and safety.
The trial met its primary endpoint at the interim analysis, with an HR for RFS of 0.42 (95% CI, 0.3-0.59), the press release stated. Researchers observed higher 12-months RFS rates with nivolumab vs. placebo overall (89% vs. 79%) and by stage (IIB, 93% vs. 84%; IIC, 84% vs. 72%). Grade 3 to grade 4 treatment-related adverse events occurred among 10% of patients in the nivolumab group and 2% of patients in the placebo group, and treatment-related adverse events that led to discontinuation occurred in 15% of the nivolumab group vs. 3% of the placebo group.
Nivolumab is indicated for subsets of patients with several cancer types, including melanoma, non-small cell lung cancer, renal cell carcinoma, classical Hodgkin lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma, colorectal cancer, hepatocellular carcinoma, esophageal cancer and gastric cancer.
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