REACH3 study shows Jakavi significantly improves outcomes in patients with steroid-refractory/dependent chronic graft-versus-host disease. Incyte + Novartis.

Detailed results from the pivotal Phase III REACH3 study demonstrate Jakavi (ruxolitinib) 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). 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. “The damaging and sometimes deadly effects of chronic GvHD following stem cell transplant present significant treatment challenges, particularly for the nearly half of patients who do not adequately respond to steroid treatment,” said Dr. Robert Zeiser, University Hospital Freiburg, Department of Haematology, Oncology and Stem Cell Transplantation, Freiburg, Germany. “Based on the compelling REACH3 results, we now have a potential new standard of care for these patients.” 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 greater than 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. no new safety signals were observed in reach3 and adverse events aes attributable to treatment were consistent with the known safety profile of jakavi. the most common aes in the jakavi vs. bat arms were anemia 29.1 vs. 12.7 thrombocytopenia 21.2 vs. 14.6 hypertension 15.8 vs. 12.7 and pyrexia 15.8 vs. 9.5. while 37.6 and 16.5 of patients required jakavi and bat dose modifications respectively the number of patients who discontinued treatment due to aes was low 16.4 and 7 respectively. mortality rates were similar across treatment arms 19 vs. 16 bat. deaths reported as primarily due to chronic gvhd were slightly higher for jakavi. in 2019 the fda approved ruxolitinib marketed by incyte corporation in the u.s. as jakafi for the treatment of steroid-refractory acute gvhd in adult and pediatric patients 12 years and older based on results of the single-arm phase ii reach1 trial. reach3 nct03112603 is a phase iii randomized open-label global multicenter study to evaluate jakavi compared to bat in patients with steroid-refractory or steroid-dependent chronic gvhd following allogeneic stem cell transplant . regulatory filings for steroid-refractory dependent gvhd in europe and other ex-us countries based on these data are planned for the first half of 2021.>