Novartis announces first data from REACH3 trial showing Jakavi (ruxolitinib) significantly improved outcomes in patients with steroid-resistant/dependent chronic GvHD

Nachrichtenquelle: globenewswire
04.12.2020, 18:30  |  196   |   |   

  • Results of REACH3 trial also demonstrate significant improvements in failure-free survival (FFS) and patient-reported symptoms1
  • Chronic graft-versus-host disease (GvHD) is a life-threatening complication of stem cell transplants and half of patients become steroid refractory/dependent2,3
  • Findings from the study were presented at ASH 2020, and complement previously reported positive results for Jakavi in acute GvHD; data to be submitted to ex-U.S. health authorities4

Basel, December 4, 2020 — 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)1. The results of REACH3, the first successful, randomized Phase III trial in chronic GvHD, were presented today 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 study1. 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)1.
  • 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 ≥ 7 points of total symptom score (TSS) from baseline of the modified Lee Symptom Score (mLSS)1.
  • 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 arm1.

“These impressive results in chronic GvHD, which complement previous positive findings in the acute form of the disease, clearly define the role Jakavi can play in improving outcomes for patients facing this difficult-to-treat condition,” said David Feltquate, Head Hematology Development Unit, Novartis. “Jakavi is the first treatment to demonstrate efficacy in a large-scale randomized clinical trial in steroid-refractory/dependent chronic GvHD, and with these meaningful data we look forward to advancing discussions with regulatory authorities.”

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Novartis announces first data from REACH3 trial showing Jakavi (ruxolitinib) significantly improved outcomes in patients with steroid-resistant/dependent chronic GvHD Results of REACH3 trial also demonstrate significant improvements in failure-free survival (FFS) and patient-reported symptoms1Chronic graft-versus-host disease (GvHD) is a life-threatening complication of stem cell transplants and half of patients …

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