Novartis announces Phase III study of Jakavi® in chronic graft-versus-host disease met primary and key secondary endpoints
Novartis today announced that the Phase III REACH3 study evaluating Jakavi® (ruxolitinib) in patients with steroid-refractory or steroid-dependent chronic graft-versus-host disease (GvHD) met its primary endpoint of superior overall response rate (ORR) at Week 24 versus best available therapy (BAT)1. The study also met key secondary endpoints, significantly improving failure-free survival and patient-reported symptoms assessed by a validated chronic GvHD-specific score1. These topline results build on positive data from the previously reported REACH2 trial, which demonstrated that Jakavi improved outcomes across a range of efficacy measures in patients with steroid-refractory or steroid-dependent acute GvHD2.
“These positive topline results of the pivotal Phase III trial in chronic GvHD show that treatment with Jakavi results in superior overall response and failure-free survival compared to alternative treatment options and will help to inform treatment decisions among patients refractory to steroids following bone marrow transplantation,” said David Feltquate, Head Hematology Development Unit, Novartis. “We look forward to sharing further details of the data, which complement the previous findings for Jakavi in the acute form of the disease, and plan to initiate regulatory filings for steroid-refractory GvHD in Europe and other ex-US countries.”
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 transplant4. Data from this study are expected to be presented at an upcoming major medical congress.
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