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Ruxolitinib for steroid-refractory or steroid-dependent chronic GvHD: 3-year final analysis of the REACH3 trial
Corticosteroids remain the standard first-line treatment for chronic graft-versus-host disease (cGvHD). However, alternative treatments are needed for patients who are steroid-refractory or dependent (SR/D). The phase III REACH3 trial (NCT03112603) demonstrated superiority of ruxolitinib (10 mg twice daily) vs best available therapy (BAT) at 24 weeks (primary analysis) in patients with SR/D-cGvHD. Patients then continued with randomized treatment and entered the long-term survival follow-up; those randomly assigned to BAT crossed over to ruxolitinib (Weeks 24–156). Results from the 3-year final analysis of the REACH3 trial were published by Zeiser et al. in the Journal of Clinical Oncology.1 Key outcomes, analyzed in the full analysis set (n = 329: ruxolitinib, n = 165; BAT, 164), included failure-free survival, duration of response, overall survival, non-relapsed mortality, and malignancy relapse/recurrence. Overall response rate and best overall response were analyzed in the crossover analysis set (n = 70).
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Key learnings |
Median FFS was longer with ruxolitinib compared with BAT (38.4 months vs 5.7 months; HR, 0.36; 95% CI, 0.27–0.49). The high probability of FFS was sustained up to 36 months with ruxolitinib vs BAT (56.5% vs 18.2%). |
Median DoR was not reached in the ruxolitinib group vs 6.4 months in the BAT group, with a higher probability of sustaining a response up to 36 months with ruxolitinib vs BAT (59.6% vs 26.7%). Median OS was not reached. |
Rates of NRM (17.8% vs 22.0%) and relapse (8.5% vs 7.5%) were low in the ruxolitinib vs BAT groups. In the crossover analysis set, ruxolitinib achieved ORR of 50.0% and BOR of 81.4%. No new safety signals were observed. |
The timing of crossover had no impact on outcomes, supporting the clinical benefit of ruxolitinib in the second- or third-line setting. The long-term analysis demonstrated sustained efficacy and safety of ruxolitinib in patients with SR/D-cGvHD over 3 years. |
BAT, best available therapy; BOR, best overall response; cGvHD, chronic graft-versus-host disease; DoR, duration of response; FFS, failure-free survival; HR, hazard ratio; NRM, non-relapse mortality; ORR, overall response rate; OS, overall survival; SR/D, steroid-refractory/steroid-dependent.
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