Opinion

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Ruxolitinib in Chronic GVHD

The expert panel explores the approval of ruxolitinib for chronic GVHD based on the REACH3 trial. The panel highlights the trial’s outcomes, long-term follow-up data, and the evolving shift in clinical practices.

This is a video synopsis of a discussion involving Dr Yi-Bin Chen, Director of the Transplant and Cell Therapy Program at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School; Dr Corey Cutler, Director of the Stem Cell Transplant Program at Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School; Dr Mitchell Horwitz, Professor of Medicine and Director of the Adult Blood and Marrow Transplant Program at Duke University, and Dr Hannah Choe, Assistant Professor and Director of the Graft-versus-Host-Disease (GVHD) program at Ohio State University.

The panelists delve into the approval of ruxolitinib for chronic GVHD based on the REACH3 trial.

The REACH3 trial, a phase 3 randomized trial, compared ruxolitinib to the best available therapy for chronic GVHD. Dr Choe outlines the trial's design, which included over 300 patients, and its positive outcome, demonstrating a significant improvement in overall response rate at week 24 for ruxolitinib compared to the best available therapy. The approval of ruxolitinib for steroid-refractory or steroid-dependent chronic GVHD resulted from these promising results.

Dr Choe discusses common adverse events observed during the trial, such as cytopenia, thrombocytopenia, anemia, and neutropenia, which are consistent with known side effects of ruxolitinib. Long-term monitoring also revealed elevated liver transaminases and gamma-glutamyl transferase with prolonged use.

The panelists highlight the consistency of the results with previous data, including a three-year follow-up presented by Dr Robert Zeiser at ASH [American Society of Hematology] Annual Meeting 2023, confirming the prolonged failure-free survival rate. Notably, patients crossing over from the best available therapy to ruxolitinib showed similar response rates to those initially randomized to ruxolitinib.

Dr Yi-Bin Chen emphasizes the validation of practices moving towards ruxolitinib as the first option for second-line therapy in chronic GVHD, as discussed in Dr Zeiser's presentation.

In summary, the discussion provides insights into the REACH3 trial, the approval of ruxolitinib for chronic GVHD, and the consistent positive outcomes observed in long-term follow-up data, influencing the shift in clinical practices.

Video synopsis is AI-generated and reviewed by OncLive® editorial staff.

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