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Elizabeth Buchbinder, MD, discusses the investigation of treatment with nivolumab maintenance therapy in patients with melanoma who experienced severe immune-related adverse effects associated with combination therapy with nivolumab and ipilimumab.
Elizabeth Buchbinder, MD, assistant professor, Medicine, Harvard Medical School, senior physician, Medical Oncology, Dana-Farber Cancer Institute, discusses the investigation of treatment with nivolumab (Opdivo) maintenance therapy in patients with melanoma who experienced severe immune-related adverse effects (irAEs) associated with combination therapy with nivolumab and ipilimumab (Yervoy).
Data from a retrospective analysis that were presented at the 2023 ASCO Annual Meetingrevealed practice discrepancies that were unrelated to patient factors but influenced by physician considerations. The study demonstrated a 68% reduction in the risk of death among patients who resumed nivolumab monotherapy (n = 46) compared with those who did not (n = 76; HR, 0.32; 95% CI, 0.12-0.84). Among patients who resumed treatment, 26% (n = 12) encountered any-grade irAEs, with 5 patients experiencing grade 3 irAEs. However, no grade 4 or 5 irAEs were reported. The observed irAE rates and improved survival in patients resuming maintenance nivolumab indicate the potential benefit of administering additional immunotherapy following the resolution of initial severe irAEs. Buchbinder explains that these outcomes emphasize the need for additional prospective investigation of this topic.
Because this is a retrospective study, it's crucial to prospectively validate these data or include significantly larger numbers before considering changes in practice, Buchbinder begins. Nevertheless, the findings are intriguing and prompt thoughtful consideration, she states. Notably, there are observable variations in how providers globally approach the continuation of nivolumab, Buchbinder explains.
Although much work remains in this domain, initiating dialogue about this topic may catalyze further research, Buchbinder continues. The initial step involves building upon the findings from the retrospective analysis by assembling a more extensive dataset from other institutions to explore whether these trends persist with a broader patient cohort, she notes. However, given the retrospective nature of this research, prospective validation would be desirable for more robust confirmation of the findings, Buchbinder concludes.