Nivolumab followed by ipilimumab may be more clinically beneficial in contrast with the reverse sequence for treatment in patients with advanced melanoma, according to a study published in The Lancet Oncology.1
Researchers led by Jeffrey Weber, MD, of the New York University Langone Medical Center, conducted a randomized, open-label, phase 2 study of 140 patients who were randomly assigned to induction with intravenous nivolumab, followed by a planned switch to intravenous ipilimumab or the reverse sequence.
Primary endpoint was treatment-related grade 3 to 5 adverse events until week 25; secondary endpoints were “the proportion of patients who achieved a response at week 25 and disease progression at weeks 13 and 25.”
The researchers found that the proportion of patients with a response at week 25 was higher with nivolumab followed by ipilimumab than with the reverse sequence. Progression was found in 26 patients in the nivolumab followed by ipilimumab group, in contrast with 43 in the reverse sequence group at week 13; at week 25, progression was found in 26 patients in the former group and 42 in the latter.
The frequencies of treatment-related grade 3 to 5 adverse events up to week 25 were similar between the nivolumab followed by ipilimumab group and the reverse sequence group.
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With a median follow-up of 19.8 months, median overall survival was not reached in the nivolumab followed by ipilimumab group. Median overall survival was found to be 16.9 months in the ipilimumab followed by nivolumab group, with a median follow-up of 14.7 months.
It was found that a higher proportion of patients in the nivolumab followed by ipilumumab group achieved 12-month overall survival.
- Weber JS, Gibney G, Sullivan RJ, Sosman JA, Slingluff Jr CL, Lawrence DP, et al. Sequential administration of nivolumab and ipilimumab with a planned switch in patients with advanced melanoma (CheckMate 064): an open-label, randomised, phase 2 trial. [published online ahead of print June 4, 2016.] The Lancet Oncol. doi: