Discontinuing nivolumab-ipilimumab treatment because of adverse events may not have a detrimental impact on survival among patients with advanced melanoma, according to follow-up from a randomized trial presented at the American Society of Clinical Oncology Annual Meeting (June 3-7, 2016; Chicago, IL).
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In a trial enrolling 142 patients to receive nivolumab plus ipilimumab or a placebo plus ipilimumab, investigators led by F Stephen Hodi, MD, director of the melanoma center at Dana-Farber Cancer Institute in Boston, MA, looked at how survival changed in patients who discontinued treatment due to toxicity.
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At follow-up, the 1- and 2-year overall survival rates did not differ significantly between those who continued treatment with nivolumab and ipilimumab and those who discontinued due to adverse events. Additionally, the overall and progression-free survival of both groups was longer than what was observed in patients randomly assigned to receive ipilimumab monotherapy.
Further, according to Targeted Oncology, patients who discontinued treatment with nivolumab and ipilimumab had an overall response rate of 66%, with 27% of patients achieving a complete response and 69% experiencing a reduction in tumor burden.
However, ipilimumab monotherapy was found to have a much more manageable safety profile, with only 22% of patients experiencing grade 3 or 4 treatment-related adverse events versus 55% of patients who received nivolumab and ipilimumab, which led to treatment discontinuation in 37% of patients.
From these results, investigators concluded that discontinuing nivolumab-ipilimumab treatment for advanced melanoma may not have a significant impact on survival in patients with advanced melanoma.
“Median progression-free survival and median duration of response were not reached at a minimum follow-up of 2 years, indicating durability of nivolumab-ipilimumab efficacy, even in patients who discontinued,” said Dr Hodi. ““In this post-hoc analysis, patients who experienced a treatment-related adverse event leading to discontinuation appeared to derive similar benefit from nivolumab-ipilimumab combination therapy, despite discontinuing early.”
