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Ruxolitinib in pediatric patients with chronic GvHD: Interim results from REACH5
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The ongoing phase II REACH5 trial (NCT03774082) is assessing the safety and efficacy of ruxolitinib plus corticosteroids for the treatment of corticosteroid-refractory or treatment-naïve pediatric patients with moderate-to-severe chronic graft-versus-host disease (GvHD).1 The study design has previously been reported by the GvHD Hub. Interim results from this trial, including the final evaluation of the primary endpoint, were published in Lancet Haematology by Locatelli, et al.1 |
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The overall response rates at Cycle 7 Day 1 (primary endpoint) were 40.0%, 41.2%, and 39.3% in all patients, treatment-naïve patients, and corticosteroid-refractory patients, respectively. |
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The safety profile of ruxolitinib in pediatric patients was consistent with the known safety profile in adult and adolescent patients, with the most common treatment-related adverse events (TRAEs) being neutropenia (24%), thrombocytopenia (18%), and anemia (16%).
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Median overall survival and failure-free survival were not reached, and at 12-months the estimated probability of survival and failure-free survival were 84.2% and 66.7%, respectively. |
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These findings demonstrate the tolerable safety profile and high response rates of ruxolitinib plus corticosteroids in treatment-naïve and corticosteroid-refractory patients aged 2–18 years with chronic GvHD. The final analysis of this trial will provide further data on the long-term safety and efficacy of ruxolitinib in this patient population. |
- Locatelli F, Antmen B, Kang HJ, et al. Ruxolitinib in treatment-naive or corticosteroid-refractory paediatric patients with chronic graft-versus-host disease (REACH5): Interim analysis of a single-arm, multicentre, phase 2 study. Lancet Haematol. 2024;11(8):e580-e592. DOI: 1016/S2352-3026(24)00174-1
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