Immune-Related Adverse Events—A Novel Prediction of Nivolumab Efficacy?—Reply

In Reply We thank Cheng and colleagues for their interest in our study on the association of immune-related adverse events (irAEs) with nivolumab efficacy. We agree that programmed cell death ligand 1 (PD-L1) expression on tumor cells is also an important predictive marker for nivolumab efficacy in nonsquamous non–small cell lung cancer, as previously shown in the Checkmate 057 trial. The PD-L1 tumor proportion score (TPS) as determined by immunohistochemical analysis with the monoclonal antibody 28-8 was available for only 54 of the patients with nonsquamous non–small cell lung cancer in our cohort at the 6-week landmark analysis of progression-free survival (PFS), with 43 of these patients having a PD-L1 TPS of less than 50% and 11 a PD-L1 TPS of 50% or greater. These numbers are too small to allow detection of a statistically significant difference in PFS in either subgroup between individuals with irAEs and those without irAEs. However, there was a nonsignificant finding of a longer PFS in patients with irAEs than in those without such events for the subgroups with either a low (hazard ratio, 0.58; 95% CI, 0.29-1.16; log-rank P = .12) or high (hazard ratio, 0.19; 95% CI, 0.008-2.05; log-rank P = .16) PD-L1 TPS. Although further studies will be needed to confirm these preliminary findings, they suggest that the occurrence of irAEs may be predictive of nivolumab efficacy at least in part in a manner independent of the PD-L1 expression level on tumor cells.

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