Incyte and partner Novartis confirmed plans to file for U.S. and European regulatory approval of the janus kinase (JAK) inhibitor ruxolitinib (INC424 or INCB18424) as a treatment for myelofibrosis (MF) within the next few months, following the release of positive data from a second Phase III study. The European Comfort-II study showed that compared with best available therapy, ruxolitinib treatment led to statistically significant reductions in spleen size among patients with primary MF, post-polycythemia vera myelofibrosis (PPV-MF), or post-essentional thrombocythemia myelofibrosis (PET-MF). The trial was sponsored by Novartis.
Comfort-II enrolled 219 patients with primary MF, PPV-MF, or PET-MF at study sites across Europe. The primary endpoint was the proportion of patients achieving a reduction in spleen volume of more than 35% from baseline by week 48. Data from the European study support those from Incyte’s Phase III study, Comfort-I, which was carried out in North America and Australia. The firms reported positive data from Comfort-I at the end of December 2010.
“The Comfort-I and II trials constitute the largest clinical trial program to date in myelofibrosis,” notes Richeard Levy, M.D., Incyte’s executive vp and chief drug development and medical officer. “Data from these two Phase III trials demonstrate how treatment with ruxolitinib was more effective than placebo and any other available medical therapies.”
Ruxolitinib is a JAK1 and JAK2 inhibitor developed by Incyte. The drug is also undergoing a global Phase III registrational trial as a treatment for polycythemia vera, and is in Phase II evaluation in patients with acute leukemias. The firm says additional clinical trials evaluating ruxolitinib in other hematologic cancers and malignancies including lymphoma and pancreatic cancer are planned in 2011.
Novartis negotiated ex-U.S. rights to ruxolitinib and global rights to Incyte’s Phase I-stage cMET inhibitor INCB28060 back in 2009. Under terms of the deal, Novartis paid Incyte $150 million up front and another $60 million on initiation of the European Phase III ruxolitinib trial.