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FDA analysis of patients with baseline autoimmune diseases treated with PD-1/PD-L1 immunotherapy agents.

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3018Background: With FDA approval of three novel agents targeting the PD-L1/PD-1 checkpoint pathway in multiple tumor types, use of these agents in the clinical setting is becoming increasingly common. However,… Click to show full abstract

3018Background: With FDA approval of three novel agents targeting the PD-L1/PD-1 checkpoint pathway in multiple tumor types, use of these agents in the clinical setting is becoming increasingly common. However, little is published on their use in patients with a history of autoimmune diseases. We therefore aimed to collect safety data on patients with a history of autoimmune diseases treated with PD-1/PD-L1 immunotherapy agents in a clinical trial setting. Methods: Data on patients with a history of autoimmune disease were collected for four different PD-1/PD-L1 immunotherapy agents. Information collected included name of autoimmune disease, corticosteroid dependency at baseline, duration of dosing, immune-related adverse events (iRAEs) and worsening of underlying autoimmune disease. Results: In total, 552 patients enrolled in 22 clinical trials of PD-1/PD-L1 immunotherapy agents were identified with a history of autoimmune disease. None were known to be dependent on systemic corticosteroids at baseline. ...

Keywords: immunotherapy agents; autoimmune diseases; diseases treated; treated immunotherapy; history autoimmune

Journal Title: Journal of Clinical Oncology
Year Published: 2017

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