Grade 3 elevated lipase or amylase may not require treatment, and grade 4 events may resolve with treatment interruption. Much of the toxicity occurs early with the concurrent regimen, and lessens during maintenance with nivolumab alone, he added.
Of the 94 patients in cohorts 1-3 and 8, 22 (23%) discontinued therapy due to treatment-related adverse events. One patient died from multiorgan failure associated with treatment-induced colitis; this patient was in cohort 8.
The study is supported by Bristol-Myers Squibb, Medarex, and Ono Pharma USA. Dr. Sznol disclosed consultant/advisory relationships with Bristol-Myers Squibb and several other companies. Dr. Weber disclosed consulting/advising, and received honoraria and research funding from Bristol-Myers Squibb and other companies. Dr. O’Day has received grants for research support from Bristol-Myers Squibb and Medarex, and he has served on the speakers bureau for Bristol-Myers Squibb.