In the 3-year final analysis of the phase III REACH3 trial reported in the Journal of Clinical Oncology, Zeiser et al compared the use of ruxolitinib vs best available therapy (BAT) in terms of failure-free survival and duration of response in patients with steroid-refractory or -dependent chronic graft-vs-host disease (SR/D-cGVHD).
Study Details and Findings
In the international open-label trial, 329 patients were randomly assigned to receive ruxolitinib at 10 mg twice daily (n = 165) or best available therapy (n = 164) for 24 weeks. During weeks 24 to 156, patients continued to randomly assigned treatment, entered long-term survival follow-up, or crossed over from best available therapy to ruxolitinib.
Median failure-free survival was 38.4 months in the ruxolitinib group vs 5.7 months in the best available therapy group (hazard ratio [HR] = 0.36, 95% confidence interval [CI] = 0.27–0.49). The rate at 36 months was 56.5% vs 18.2%.
Among the 126 patients receiving ruxolitinib and the 103 receiving best available therapy with a complete or partial response, median duration of response was not reached in the ruxolitinib group vs 6.4 months in the best available therapy group. Response was maintained at 36 months in 59.6% of the ruxolitinib responders vs 26.7% of best available therapy responders.
Median overall survival was not reached (HR = 0.85, 95% CI = 0.54–1.33). At 36 months, nonrelapse mortality events (17.8% vs 22.0%) and malignancy relapse/recurrence events (8.5% vs 7.5%) were similar between the groups. Among 70 patients who crossed over to receive ruxolitinib, complete or partial response was observed in 50.0%, with 73.3% of responders maintaining response at > 2 years.
No new safety signals were observed.
The investigators concluded: “Ruxolitinib provided longer [failure-free survival] and [duration of response] than BAT, demonstrating sustained efficacy and manageable safety over 3 years of follow-up in patients with SR/D-cGVHD.”
Robert Zeiser, MD, of the Medical Center, University of Freiburg, Freiburg, Germany, is the corresponding author of the Journal of Clinical Oncology article.
Disclosure: The study was supported by Novartis and Incyte. For full disclosures of all study authors, visit the Journal of Clinical Oncology.
