Novartis and Incyte have reported positive results from the Phase III REACH2 clinical trial of Jakavi (ruxolitinib) conducted in steroid-refractory acute graft-versus-host disease (GvHD) patients.
Jakavi is an oral, JAK 1 and JAK 2 tyrosine kinases inhibitor. It has US regulatory approval to treat GvHD in patients aged 12 and above, and for polycythemia vera (PV) in adults with an inadequate response or intolerance to hydroxyurea.
Incyte markets the drug in the US, while Novartis licensed the development and commercialisation rights outside the country.
Sponsored by Novartis, the REACH2 trial compared the safety and efficacy of ruxolitinib to that of the best available therapy in participants with steroid-refractory acute GVHD.
The primary endpoint of the multi-centre, randomised, open-label study was overall response rate (ORR) at day 28. The trial’s secondary endpoints included durable ORR at days 14 and 56, duration of response, overall survival and event-free survival.
Top-line data showed that the trial met the primary endpoint of improving ORR at day 28 in patients treated with Jakavi versus the best available therapy.
Investigators did not report any new safety signals during the trial. The safety profile of the drug was observed to be consistent with previously reported data in steroid-refractory acute GVHD.
The company intends to carry out discussions with regulatory authorities outside the US in 2020.
Novartis chief medical officer and Global Drug Development head John Tsai said: “As many as half of hematopoietic stem cell transplant recipients develop acute GvHD.
“We are delighted that Jakavi showed such promise in this very difficult condition especially since few second-line treatment options exist. These impressive results will be part of our regulatory submissions seeking approval in Europe and other countries.”
Jakavi is also being studied in a Phase III REACH3 trial in patients with steroid-refractory chronic GVHD.