Novartis has reported that Jakavi (ruxolitinib) has met the primary and key secondary endpoints in the Phase III REACH3 clinical trial of patients with steroid-refractory or steroid-dependent chronic graft-versus-host disease (GvHD).
Jakavi is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases. Novartis obtained a licence from Incyte to develop and commercialise the drug outside the US.
The randomised, open-label, global, multi-centre REACH3 trial was conducted to compare Jakavi to best available therapy (BAT) in GvHD patients after allogeneic stem cell transplant.
According to the data, the trial met its primary endpoint of superior overall response rate (ORR) with Jakavi at week 24, compared to BAT.
The trial also met key secondary endpoints with significant improvement in failure-free survival and patient-reported symptoms.
Novartis Hematology development unit head David Feltquate said: “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.
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“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.”
In April this year, Novartis reported positive data from the Phase III REACH2 trial of Jakavi in patients with steroid-refractory acute GvHD.
REACH2 met its primary endpoint, where participants on Jakavi showed significantly greater overall response rate (ORR) at 62% versus 39% with BAT at day 28.
The drug also led to improved outcomes on multiple efficacy measures versus BAT.
Jakavi holds approval in more than 100 countries to treat patients with primary myelofibrosis (MF) and in more than 85 countries for patients with polycythemia vera (PV).