Ruxolitinib improves steroid-refractory aGVHD across subtypes

Ruxolitinib demonstrated superiority to standard therapy across subtypes in a phase 3 trial of patients with steroid-refractory acute graft-versus-host disease (aGVHD).

Prof. Robert Zeiser (University Hospital Freiburg, Germany) presented a follow-up analysis of the phase 3 REACH2 trial [1], which was published last month in the New England Journal of Medicine [2]. In the published analysis, ruxolitinib improved outcomes in patients (n=309) with steroid-refractory aGVHD after 28 days of treatment (62.3% vs 39.4%; P<0.001).

In this follow-up analysis, Prof. Zeiser examined the therapy responses in different subgroups of patients of the REACH2 trial. Several subgroups of patients responded better to ruxolitinib than to standard therapy, including younger patients aged 18-65 years, patients with varying degrees of disease severity, or patients with organ involvement. Furthermore, clinical benefit favoured ruxolitinib no matter whether patients had a related or unrelated donor, or whether prior GVHD therapy had been administered. Additionally, when compared with standard therapy, a higher percentage of patients treated with ruxolitinib had a response at day 28 and maintained response at day 56 (39.6% vs 21.9%; P<0.001).

No new or unexpected safety concerns were reported. In summary, this study showed that ruxolitinib is more effective than standard therapy, with ruxolitinib resulting in a clinically meaningful treatment benefit for patients with steroid-refractory aGVHD across all different subgroups analysed.

1. Zeiser R, et al. Ruxolitinib versus best available therapy in patients with steroid-refractory acute graft-versus-host disease: overall response rate by baseline characteristics in the randomized phase 3 REACH2 trial. EHA25 Virtual, 11-21 June 2020, Abstract S255.
2. Zeiser R, et al. Ruxolitinib for Glucocorticoid-Refractory Acute Graft-versus-Host Disease. N Engl J Med. 2020;382(19):1800‐1810.

Posted on 9 September, 202022 February, 2024