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
Abstract
Severe immune-related adverse events (irAE) in cancer patients receiving immune checkpoint inhibitors (ICI) require treatment interruption and immunosuppression. Based on prior preclinical data, in this prospective, single arm, non-randomized phase-Ib/II clinical trial we test the activity of Extracorporeal Photopheresis (ECP) against steroid-refractory irAEs in 30 patients (EudraCT-No.:2021-002073-26). The primary endpoint is the evaluation of the safety of ECP treatment for patients with ICI-induced irAEs. The study meets its pre-specified primary endpoint of less than 50% of patients developing ECP-related severe adverse events (SAE). No ECP-related SAE is observed and ECP-related AEs are reported in 20% (6/30) of patients. Overall response rate for all irAEs is 96.3% (CI 81.0–99.91). Colitis-, hepatitis- and dermatitis-specific response rates are 100% (13/13), 86.7% (13/15) and 100% (3/3), respectively. Secondary endpoints include the assessment of response rate of irAE and overall survival. ECP therapy is associated with reduced granzyme-A/B/K, T-bet, interferon-γ and TNF in peripheral T cells and pro-inflammatory gene-expression in the intestinal tract. The 12-month overall survival rate is 84.3% (CI 63.4%-93.8%). Response correlates with a decrease in inflammatory gene expression in the intestinal tract. These results suggest that ECP is a safe treatment option for SR-irAEs and warrant further investigation in subsequent randomized clinical trials.
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BibTeX
@article{riemer2026extracorporeal,
title = {{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}},
author = {Roxane Riemer and Lukas M. Braun and Sophie Giesler and David Rafei-Shamsabadi and Sebastian Haferkamp and Alina Hartmann and Wolfgang Melchinger and Matthias Weiss and Stefanie Birth and Ulrike Philipp and Inga Gebhard and Carsten Schwänen and James A. Hutchinson and Nikolaos Karantzelis and Till Wallrabenstein and Theresa Lowinus and Niklas Brehm and Justyna Rawluk and Dietmar Pfeifer and Natascha Osswald and Peter Bronsert and Manuel Rogg and Grigor Andreev and Melanie Boerries and Maximilian Lammer and Van Anh Nguyen and Matthias Schmuth and Natalie Köhler and Justus Duyster and Gabriele Ihorst and Philip Keye and Susana Minguet and Dirk Schadendorf and Selma Ugurel and Robert Thimme and Peter Hasselblatt and Erika L. Pearce and Burkhard Becher and Carolin Funke-Lorenz and Florian Scherer and Bertram Bengsch and Christoph Schell and Jan-Malte Placke and Frank Meiss and Petya Apostolova and Robert Zeiser},
journal = {Nature Communications},
year = {2026},
month = oct,
doi = {10.1038/s41467-026-78897-9},
url = {https://www.nature.com/articles/s41467-026-78897-9},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - 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
AU - Roxane Riemer
AU - Lukas M. Braun
AU - Sophie Giesler
AU - David Rafei-Shamsabadi
AU - Sebastian Haferkamp
AU - Alina Hartmann
AU - Wolfgang Melchinger
AU - Matthias Weiss
AU - Stefanie Birth
AU - Ulrike Philipp
AU - Inga Gebhard
AU - Carsten Schwänen
AU - James A. Hutchinson
AU - Nikolaos Karantzelis
AU - Till Wallrabenstein
AU - Theresa Lowinus
AU - Niklas Brehm
AU - Justyna Rawluk
AU - Dietmar Pfeifer
AU - Natascha Osswald
AU - Peter Bronsert
AU - Manuel Rogg
AU - Grigor Andreev
AU - Melanie Boerries
AU - Maximilian Lammer
AU - Van Anh Nguyen
AU - Matthias Schmuth
AU - Natalie Köhler
AU - Justus Duyster
AU - Gabriele Ihorst
AU - Philip Keye
AU - Susana Minguet
AU - Dirk Schadendorf
AU - Selma Ugurel
AU - Robert Thimme
AU - Peter Hasselblatt
AU - Erika L. Pearce
AU - Burkhard Becher
AU - Carolin Funke-Lorenz
AU - Florian Scherer
AU - Bertram Bengsch
AU - Christoph Schell
AU - Jan-Malte Placke
AU - Frank Meiss
AU - Petya Apostolova
AU - Robert Zeiser
PY - 2026
DA - 2026/10/23
JO - Nature Communications
DO - 10.1038/s41467-026-78897-9
UR - https://www.nature.com/articles/s41467-026-78897-9
AB - Severe immune-related adverse events (irAE) in cancer patients receiving immune checkpoint inhibitors (ICI) require treatment interruption and immunosuppression. Based on prior preclinical data, in this prospective, single arm, non-randomized phase-Ib/II clinical trial we test the activity of Extracorporeal Photopheresis (ECP) against steroid-refractory irAEs in 30 patients (EudraCT-No.:2021-002073-26). The primary endpoint is the evaluation of the safety of ECP treatment for patients with ICI-induced irAEs. The study meets its pre-specified primary endpoint of less than 50% of patients developing ECP-related severe adverse events (SAE). No ECP-related SAE is observed and ECP-related AEs are reported in 20% (6/30) of patients. Overall response rate for all irAEs is 96.3% (CI 81.0–99.91). Colitis-, hepatitis- and dermatitis-specific response rates are 100% (13/13), 86.7% (13/15) and 100% (3/3), respectively. Secondary endpoints include the assessment of response rate of irAE and overall survival. ECP therapy is associated with reduced granzyme-A/B/K, T-bet, interferon-γ and TNF in peripheral T cells and pro-inflammatory gene-expression in the intestinal tract. The 12-month overall survival rate is 84.3% (CI 63.4%-93.8%). Response correlates with a decrease in inflammatory gene expression in the intestinal tract. These results suggest that ECP is a safe treatment option for SR-irAEs and warrant further investigation in subsequent randomized clinical trials.
SN - 2041-1723
ER -