Ruxolitinib Improves Outcomes for Certain Patients With GvHD

Results from the phase 3 REACH3 trial, published in the New England Journal of Medicine, demonstrated that ruxolitinib (Jakavi, Novartis) significantly improved outcomes for patients with steroid-refractory/dependent chronic graft-versus-host disease (GvHD) compared to the best available therapy (BAT). The main findings of the study—previously presented at the 62nd American Society of Hematology (ASH) Annual Meeting—were published alongside new subgroup analyses demonstrating a favorable overall response rate (ORR) across all major subgroups, including baseline individual organ involvement, at week 24.

According to the investigators, treatment with ruxolitinib resulted in a significant improvement in ORR after 24 weeks, with an ORR of 49.7% in the ruxolitinib arm compared to 25.6% in the BAT arm. Further, best overall response (BOR) rate at any time up to week 24 was achieved in 76.4% of patients in the ruxolitinib cohort, compared to 60.4% in the BAT cohort.

“Patients with chronic GvHD can experience severe and life-threatening symptoms in different organs around the body, which makes the disease more difficult to treat and increases the risk of poor outcomes,” said Dr. med. Robert Zeiser, University Hospital Freiburg, Department of Haematology, Oncology and Stem Cell Transplantation, in a press release. “With these new results from REACH3, we can see more clearly the potential benefits of what may become a new standard of care for chronic GvHD patients who have not adequately responded to first-line steroids.”

The study also found that ruxolitinib demonstrated clinically meaningful improvements in key secondary endpoints, including failure-free survival (FFS) and self-reported symptoms. Patients receiving ruxolitinib did not reach median FFS, compared to 5.7 months for the BAT cohort, and had 24.2% improvement in self-reported symptoms compared to 11% in the BAT arm. A subgroup analysis found that patients receiving ruxolitinib had improved outcomes irrespective of individual organs affected at baseline.

“These new Jakavi data underscore its potential benefits and the importance of making it available to patients at risk for an all-too-common and life-threatening complication of stem cell transplants,” said Susanne Schaffert, PhD, president of Novartis Oncology, in the release. “We are pleased that regulatory submissions are underway and will continue to work toward wide accessibility of this important new medicine for GvHD.”

REFERENCE

Novartis announces NEJM publication of positive Phase III REACH3 data for Jakavi in chronic GvHD [news release]. Novartis; July 14, 2021. Accessed July 22, 2021. https://www.novartis.com/news/media-releases/novartis-announces-nejm-publication-positive-phase-iii-reach3-data-jakavi-chronic-gvhd