Novartis announces data showing Jakavi (ruxolitinib) more effective than best available therapy in acute graft-versus-host disease

• Data from Phase III REACH2 study, published in The New England Journal of Medicine, demonstrate Jakavi can improve outcomes for patients with acute graft-versus-host disease (GvHD) who do not respond to first-line steroid treatment¹
   
• Results show 62% overall response rate with Jakavi at Day 28, the primary endpoint of the study, compared to 39% for best available therapy¹
   
• GvHD is a serious and common complication of allogeneic stem cell transplants with a one-year death rate as high as 80% in its acute form^2-4

Basel, April 22, 2020 — Data from the Phase III REACH2 study published today in The New England Journal of Medicine show Jakavi (ruxolitinib) improves outcomes across a range of efficacy measures in patients with steroid-refractory acute graft-versus-host disease (GvHD) compared to best available therapy (BAT). The results of REACH2, the first Phase III study in acute GvHD to have met its primary endpoint, reinforce findings of the previously reported Phase II REACH1 study. The new data was also selected for presentation at the Presidential Symposium of the European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting, to be held 30 August to 2 September in Madrid.

In REACH2, patients treated with Jakavi experienced significantly greater overall response rate (ORR) vs. BAT (62% vs. 39%; p<0.001) at Day 28, the primary endpoint of the study. For the key secondary endpoint, patients treated with Jakavi maintained significantly higher durable ORR (40% vs. 22%; p<0.001) at eight weeks. Additionally, Jakavi was associated with longer median failure free survival (FFS) than BAT (5.0 months vs. 1.0 months; hazard ratio 0.46, 95% CI, 0.35 to 0.60), and showed a positive trend with other secondary endpoints, including duration of response¹.

“Patients with acute graft-versus-host disease face life-threatening challenges with limited treatment options, particularly for the nearly half of individuals who do not respond to initial steroid therapy,” said Robert Zeiser, University Hospital Freiburg, Department of Haematology, Oncology and Stem Cell Transplantation, Freiburg, Germany. "These new data from REACH2 showing superiority of Jakavi over current standard-of-care therapies add to a growing body of evidence on how targeting the JAK pathway can be an effective strategy in this difficult-to-treat condition.”