Novartis unveiled positive results from a Phase 3 study evaluating Jakavi (ruxolitinib) in patients with steroid-refractory or steroid-dependent chronic graft-versus-host disease (GvHD).
The Phase 3 study, dubbed REACH3, has reached its primary endpoint of superior overall response rate (ORR) after 24 weeks, compared to best available therapy (BAT).
REACH3 has also met its key secondary endpoints of improving failure-free survival and patient-reported symptoms evaluated by a validated chronic GvHD-specific score.
Novartis haematology 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.
“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.”
Jakavi is an oral inhibitor of JAK 1 and JAK 2 tyrosine kinases
REACH3 is a Phase 3, randomised, open-label, multicentre clinical trial, designed to evaluate Jakavi versus BAT in patients with steroid-refractory or steroid-dependent chronic GvHD, after an allogeneic stem cell transplant.
Results from the Phase 3 trial follow positive data from the previously reported REACH2 trial, which showed that Jakavi improved efficacy outcomes in patients with steroid-refractory or steroid-dependent acute GvHD.
Jakavi is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases.
The drug has been approved for patients with (myelofibrosis) MF in more than 100 countries including EU countries, Switzerland, Canada, Japan and for patients with polycythemia vera (PV) in more than 85 countries, including EU countries, Switzerland, Japan and Canada.
Novartis has licensed the drug from Incyte, a US-based pharmaceutical firm, for the development and commercialisation outside the US, and is marketed as Jakafi in the US by Incyte.
