Subgroup analysis of ruxolitinib in patients with steroid-refractory acute GvHD – update from EHA 2020

The main results of the phase III REACH2 trial (NCT02913261), comparing the efficacy and safety of ruxolitinib (RUX) with nine best available therapies (BAT) in patients with steroid-refractory acute graft-versus-host-disease (SR-aGvHD), were published in The New England Journal of Medicine. The study, which was recently summarized on the GvHD Hub, demonstrated significantly improved outcomes in patients treated with RUX compared with BAT.

During the European Hematology Association (EHA) virtual meeting, Robert Zeiser from the University Hospital Freiburg, DE, presented a follow-up analysis of the REACH2 study, which examined responses in different subgroups of patients of the trial. The previously published Day-28 response rate for the overall population was 62.3% with RUX vs 39.4% with BAT (odds ratio [OR] 2.64; p < 0.001). The subsequent analysis of response by baseline characteristics revealed superior efficacy of RUX vs BAT in several subgroups of patients, including those aged 18–65 years. RUX showed better responses irrespective of the severity of aGvHD, organ involvement, donor type, and type of prior conditioning regiment, and prior GvHD therapy used (Table 1).

Table 1. Subgroups with higher overall response rates at Day-28 for RUX vs BAT

Furthermore, RUX induced higher rates of response at Day 28, which were maintained at Day 56, than BAT (39.6% vs 21.9%; p < 0.001). The cumulative incidence of loss of response at 6 months for RUX and BAT were 9.65% (95% CI, 4.39–17.4) and 39.96 (95% CI, 25.54–52.19), respectively. The safety profile was consistent with that previously reported. There were no new or unexpected safety concerns.