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REACH2 final analysis: Ruxolitinib vs BAT in SR-aGvHD
Results from the final analysis of the randomized phase III REACH2 trial evaluating ruxolitinib (n = 154) vs best available therapy (BAT; n = 155) in patients aged ≥12 years with steroid-refractory acute graft-versus-host disease (SR-aGvHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT) were recently published in the Journal of Clinical Oncology by Mohty et al. Patients randomized to BAT were able to crossover to ruxolitinib on or after Day 28 (n = 49) due to lack/loss of response or if they required additional therapy.
Key data: Cumulative median (range) duration of response was 167 (22–677) days with ruxolitinib and 106 (10–526) days with BAT. Median overall survival and event-free survival were 10.7 and 8.3 months for ruxolitinib, compared with 5.8 and 4.2 months, respectively, with BAT. Median failure-free survival was longer with ruxolitinib than with BAT (4.86 vs 1.02 months; p < 0.001). Safety observations were consistent with the primary analysis results.
Key learning: Ruxolitinib provided sustained efficacy advantages over BAT in patients with SR-aGvHD over 24 months of treatment. The benefit–risk ratio for ruxolitinib remains favorable and supports its use in patients aged ≥12 years with SR-aGvHD.
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