Treatment With Nivolumab Maintenance Following irAEs in Melanoma

Dr Buchbinder on Treatment With Nivolumab Maintenance Following irAEs in Melanoma

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 

revealed 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.

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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 rationale for investigating nivolumab (Opdivo) maintenance therapy in patients with melanoma who experienced severe immune-related adverse effects (irAEs) due to combination therapy with nivolumab and ipilimumab (Yervoy), and details the findings of this investigation.

Many patients with metastatic melanoma who are treated with the combination of ipilimumab and nivolumab in the frontline develop toxicity following only a few doses, Buchbinder begins. Typically, this means that treatment is stopped, and the patient will then receive steroids or another immunosuppressive therapy, followed by the decision of whether to resume immunotherapy, she says. Notably, these patients will have residual disease on the scan, Buchbinder explains.

To combat this difficult decision, some patients in this situation will be treated with nivolumab alone, Buchbinder expands. Many of the irAEs could stem from the combination of these therapies, leading to the decision to treat with nivolumab alone. However, some clinicians will opt for observation until patients experience disease progression before deciding on another treatment, Buchbinder says. Based on these varying practice patterns, investigators further examine each approach, Buchbinder emphasizes.

A retrospective analysis presented at the 2023 ASCO Annual Meeting found differences in practice that weren't based on patient factors; rather, they were based on physician factors, Buchbinder continues. Findings showed that patients who resumed nivolumab monotherapy (n = 46) experienced a 68% reduction in the risk of death compared with those who did not resume nivolumab (n = 76; HR, 0.32; 95% CI, 0.12-0.84). Among patients who resumed treatment, 26% (n = 12) experienced any-grade irAEs, and 5 patients had grade 3 irAEs. No grade 4 or 5 irAEs were reported.

Given the rates of irAEs and improved survival for patients who resumed maintenance nivolumab, these data suggest that giving more immunotherapy following the resolution of initial severe irAEs could be beneficial and should be prospectively studied, she concludes.

Elizabeth Buchbinder, MD, discusses the rationale for investigating nivolumab  maintenance therapy in patients with melanoma who experienced severe immune-related adverse effects due to combination therapy with nivolumab and ipilimumab, and details the findings of this investigation.


Elizabeth Buchbinder, MD,

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