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Background

Safety of rechallenge of immune checkpoint inhibitor (ICI) after grade≥ 2 immune-related adverse events (irAEs) leading to ICI discontinuation remains unclear.

Methods

All adverse drug reactions involving at least one ICI reported up to December 31, 2019 were extracted from the French pharmacovigilance database. Patients were included if they experienced at least one grade≥ 2 irAE resulting in ICI discontinuation, with subsequent ICI rechallenge. The primary outcome was the recurrence of at least one grade≥ 2 irAE in these patients after ICI rechallenge.

Results

We included 180 patients: 61.1% were men (median age of 66 years), 43.9% had melanoma and 78.9% were receiving anti-programmed cell death 1. First ICI discontinuation was related to 191 irAEs. After ICI rechallenge, 38.9% of the patients experienced at least one grade≥ 2 irAE. Among them, 70.0% experienced the same irAE, 25.7 …