Phase III REACH3 study of Jakavi improved outcome in chronic graft-versus-host disease.- Novartis

Detailed results from the pivotal Phase III REACH3 study demonstrate Jakavi (ruxolitinib), from Novartis, significantly improved outcomes across a range of efficacy measures in patients with steroid-refractory/dependent chronic graft-versus-host disease (GvHD) compared to best available therapy (BAT). In REACH3, patients treated with Jakavi achieved significantly greater overall response rate (ORR) compared to BAT (49.7% vs. 25.6%; p<0.0001i) at week 24, the primary endpoint of the study. jakavi also demonstrated statistically significant and clinically meaningful improvements in key secondary endpoints: patients receiving jakavi had a significant improvement of failure-free survival (ffs; defined as time to the earliest recurrence of the underlying disease, the start of new systemic treatment for chronic gvhd, or death) than patients receiving bat (median ffs not yet reached vs. 5.7 months; hazard ratio, 0.370, 95% ci, 0.268 to 0.510; p><0.0001). patients treated with jakavi also had greater improvements in patient-reported symptoms than those treated with bat (24.2% vs. 11.0%; p="0.0011)," as measured by the rate of responders who achieved a reduction of at least 7 points of total symptom score (tss) from baseline of the modified lee symptom score (mlss). additionally, best overall response (bor) rate was achieved in 76.4% of patients in the jakavi arm compared to 60.4% in the bat arm (odds ratio [or], 2.17; 95% ci, 1.34-3.52). the median duration of response was 6.24 months in the bat arm, but was not reached in the jakavi arm. the results of reach3, the first successful, randomized phase iii trial in chronic gvhd, were presented during the 62nd american society of hematology annual meeting & exposition (ash). reach3 is jointly sponsored by novartis and incyte.>