Retrospective analysis of association of irAEs with efficacy in consolidation nivolumab with or without ipilimumab after CRT for stage III NSCLC

An exploratory retrospective analysis of the randomized phase 2 BTCRC LUN 16-081 trial evaluated the association of immune-related adverse events (irAEs) with efficacy outcomes among patients receiving consolidation with nivolumab (arm A) or nivolumab plus ipilimumab (arm B) after chemoradiation for unresectable stage IIIA or IIIB NSCLC. In arm A, 65% of patients developed irAEs with no difference in PFS or OS in patients with and without irAEs. In arm B, 84% of patients developed irAEs with no difference in OS in patients with and without irAEs, but longer PFS in those who experienced irAEs (30.9 months versus 6.8 months; p=0.010). Patients in arm A who discontinued due to irAEs had shorter PFS (8.2 months versus 31.9 months; p<0.0001) and OS (12.3 months versus NE; p<0.001) than patients who did not discontinue. Patients in arm B who discontinued due to irAEs had no difference in either PFS or OS versus patients who did not discontinue. The authors conclude that development of irAEs did not result in reduced efficacy outcomes, and was associated with improved PFS in the combination arm.