Extracorporeal photopheresis for the treatment of steroid-refractory immune related adverse events from immune checkpoint inhibitor therapy: a multi-center phase Ib/II clinical trial.
Roxane Riemer, Lukas M Braun, Sophie Giesler et al.
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In 30 seconds
This prospective, single-arm, non-randomized phase Ib/II multicentre trial evaluated extracorporeal photopheresis (ECP) for steroid-refractory immune-related adverse events (irAEs) in 30 patients receiving immune checkpoint inhibitors. The primary safety endpoint was met: no ECP-related severe adverse events occurred, while ECP-related adverse events were reported in 20% (6/30). The overall response rate across irAEs was 96.3% (CI 81.0-99.91). Responses were reported for colitis, hepatitis and dermatitis, alongside reductions in inflammatory markers and intestinal gene expression. The authors conclude that ECP warrants further evaluation in randomized trials.
Key findings
- No ECP-related severe adverse events were observed; ECP-related adverse events occurred in 20% (6/30) of patients.
- The overall response rate for all irAEs was 96.3% (CI 81.0-99.91).
- Response rates were 100% (13/13) for colitis, 86.7% (13/15) for hepatitis and 100% (3/3) for dermatitis.
- The 12-month overall survival rate was 84.3% (CI 63.4%-93.8%).
Why it matters
Steroid-refractory irAEs can require treatment interruption and immunosuppression. This trial provides prospective evidence that ECP was associated with high response rates and no ECP-related severe adverse events in the studied patients. The findings may inform further evaluation of an approach to managing these complications, while the non-randomized design means comparative benefit remains uncertain.
What to keep in mind
The study was single-arm and non-randomized, with 30 patients; it cannot establish comparative efficacy against other treatments.