Novartis has reported positive data from the Phase III REACH2 clinical trial of Jakavi (ruxolitinib) in patients with steroid-refractory acute graft-versus-host disease (GvHD).
The drug led to improved outcomes on multiple efficacy measures when compared to best available therapy (BAT).
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.
For the key secondary outcome, patients who received Novartis’ drug were observed to maintain significantly higher durable ORR at eight weeks.
Novartis added that Jakavi demonstrated longer median failure free survival (FFS) than BAT and had a positive trend on additional secondary endpoints, including duration of response.
Safety analysis did not reveal any new safety signals and treatment-related adverse events (AEs) were said to be consistent with the known safety profile of the drug.
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Novartis Global Drug Development head and chief medical officer John Tsai said: “Compelling results from REACH2, the first successful randomised Phase III trial in patients with steroid-refractory acute graft-versus-host-disease, give us confidence in the potential of Jakavi to confront this difficult condition.
“We look forward to initiating discussions with ex-US regulatory authorities.”
Jakavi is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases.
The drug is approved in Europe to treat adults with polycythemia vera (PV), disease-related splenomegaly, or symptoms associated with primary myelofibrosis (MF), post-polycythemia vera MF, or post-essential thrombocythemia MF.
In 2019, the US Food and Drug Administration (FDA) approved ruxolitinib for steroid-refractory acute GvHD in adult and pediatric patients aged 12 years and older. Incyte markets the drug as Jakafi in the US.
Earlier this month, Incyte and Novartis announced plans to conduct a Phase III trial of the drug as a potential Covid-19 treatment.
This week, Incyte started a Phase III trial of ruxolitinib to treat cytokine storm caused by Covid-19 coronavirus infection in the US.