Incyte Announces First Data from REACH3 Trial Showing Ruxolitinib (Jakafi) Significantly Improved Outcomes in Patients with Steroid-Refractory or Steroid-Dependent Chronic Graft-Versus-Host Disease

Incyte (Nasdaq:INCY) today announced that detailed results from the pivotal Phase 3 REACH3 study demonstrate Jakafi (ruxolitinib) significantly improved outcomes across a range of efficacy measures in patients with steroid-refractory or steroid-dependent chronic graft-versus-host disease (GVHD) compared to best available therapy (BAT)¹. The results of REACH3, the first successful, randomized Phase 3 trial in chronic GVHD, were highlighted in a press briefing today and will be presented during the 62^nd American Society of Hematology Annual Meeting & Exposition (ASH 2020). REACH3 is jointly sponsored by Incyte and Novartis.

“The results from this large, randomized study further emphasize the role Jakafi can play as a meaningful option for patients with chronic GVHD, for whom new treatments are urgently needed,” said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapies, Incyte. “These data are important for patients living with GVHD and their physicians as they represent the continued success of Jakafi in the chronic form of the disease, a historically difficult-to-treat condition.”

In REACH3, patients treated with Jakafi achieved significantly greater overall response rate (ORR) compared to BAT (49.7% vs. 25.6%; p<0.0001⁵) at Week 24, the primary endpoint of the study⁶. Jakafi also demonstrated statistically significant and clinically meaningful improvements in key secondary endpoints:

• Patients receiving Jakafi had a significant improvement in 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) versus patients receiving BAT (median FFS not yet reached vs. 5.7 months; hazard ratio, 0.37, 95% CI, 0.27-0.51; p<0.0001)¹.
• Patients treated with Jakafi 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 ≥ 7 points of total symptom score (TSS) from baseline of the modified Lee Symptom Score (mLSS)¹.
• Additionally, best overall response (BOR) rate, defined as any response up to week 24, was achieved in 76.4% of patients in the Jakafi 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 6.2 months in the BAT arm, but was not yet reached in the Jakafi arm¹.

No new safety signals were observed in REACH3, and adverse events (AEs) attributable to treatment were consistent with the known safety profile of Jakafi. The most common AEs in the Jakafi vs. BAT arms were anemia (29.1% vs. 12.7%), hypertension (15.8% vs. 12.7%) and pyrexia (15.8% vs. 9.5%). While 37.6% and 16.5% of patients required Jakafi 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)¹. Deaths reported as primarily due to chronic GVHD were slightly higher for Jakafi.