Incyte Announces Positive Phase 3 REACH3 Study Data Published in NEJM for Ruxolitinib (Jakafi®) in Chronic Graft-Versus-Host Disease

• Phase 3 REACH3 data show that ruxolitinib (Jakafi®) significantly improved overall response rate (ORR) at Week 24 (49.7% vs. 25.6%) with a higher best overall response rate (76.4% vs. 60.4%) vs. best available therapy among patients with steroid-refractory/dependent chronic graft-versus-host disease (GVHD) 1
• Additional new subgroup analysis demonstrated higher ORR for patients treated with ruxolitinib regardless of the individual organs involved at baseline1
• Chronic GVHD is a life-threatening complication of stem cell transplants and half of patients become refractory to or dependent on first-line steroids2,3
• REACH3 data serve as the basis for the supplemental New Drug Application (sNDA) undergoing review with the U.S. Food and Drug Administration (FDA)

WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (Nasdaq:INCY) today announced that positive data from the Phase 3 REACH3 study have been published in The New England Journal of Medicine (NEJM) demonstrating that treatment with ruxolitinib (Jakafi®) resulted in significantly improved outcomes in patients with steroid-refractory or steroid-dependent chronic graft-versus-host disease (GVHD) compared to best available therapy (BAT)1. The study’s main findings, previously presented at the 62nd American Society of Hematology (ASH) Annual Meeting, were published along with new subgroup analyses showing favorable overall response rate (ORR) at Week 24 for ruxolitinib across all major subgroups, including baseline individual organ involvement1. REACH3 is jointly sponsored by Incyte and Novartis.

“Results from the REACH3 study published in NEJM are extremely compelling and underscore the potential benefits ruxolitinib can offer appropriate patients facing the serious complications associated with chronic GVHD,” said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapies, Incyte. “At Incyte, we remain committed to advancing our research and understanding of this complex disease, and will continue to work closely with the FDA to bring this innovative treatment to chronic GVHD patients, who currently have limited treatment options.”

The study found that treatment with ruxolitinib led to significant improvements in ORR at Week 24 (49.7% vs. 25.6%; odds ratio [OR], 2.99; P