As reported in the Journal of Clinical Oncology by Mohty et al, the final analysis of the phase III REACH2 trial indicates that ruxolitinib provided efficacy advantages over the best available therapy (BAT) in patients with steroid-refractory acute graft-vs-host disease (GVHD) after allogeneic hematopoietic cell transplantation. The primary analysis of the trial showed that the Janus kinase inhibitor was associated with a significantly higher overall response rate at 28 days and longer duration of response.
Study Details
In the trial, 309 patients (aged 12 or older) were randomly assigned to ruxolitinib at 10 mg twice daily (n = 154) or BAT (n = 155). The current report provides patient outcomes after 24 months of treatment.
Key Findings
The median duration of response was 167 days (range = 22–677 days) with ruxolitinib and 106 days (range = 10–526 days) with BAT. The median overall survival was 10.7 months with ruxolitinib vs 5.8 months with BAT. The median event-free survival was 8.3 vs 4.2 months. The median failure-free survival was significantly longer with ruxolitinib (4.9 vs 1.0 months, P < .001). Nonrelapse mortality events occurred in 72 patients in the ruxolitinib group vs 71 in the BAT group, with relapse or disease progression events remaining low in both groups. Chronic GVHD rates were numerically higher in the ruxolitinib group vs the BAT group at ≥ 12 months, although 95% confidence intervals overlapped.
The investigators concluded: “Ruxolitinib provided efficacy advantages over BAT in patients with [steroid-refractory acute] GVHD over 24 months.”
Mohamad Mohty, MD, PhD, of Hȏpital Saint-Antoine, Assistance Publique–Hȏpitaux de Paris, Université Sorbonne, Paris, is the corresponding author of the Journal of Clinical Oncology article.
Disclosure: The study was supported by Novartis Pharma AG. For full disclosures of all study authors, visit ascopubs.org.
