Incyte, Novartis Ruxolitinib Trial Shows Promise

Incyte Corporation’s COMFORT-II, the second Phase III trial of investigational Janus kinase (JAK) inhibitor, ruxolitinib, has met its primary endpoint of significantly reducing spleen size in patients with myelofibrosis (MF), when compared to best available therapy. This trial was conducted by Novartis as part of the Incyte-Novartis worldwide collaboration and license agreement for ruxolitinib.

The study showed treatment with ruxolitinib provided a statistically significant reduction in spleen size in patients with primary MF, post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF), when compared with best available therapy. Also, the safety profile of ruxolitinib was consistent with previous studies.

“The positive results from the European COMFORT-II trial confirm the data from the U.S. trials and further strengthen our confidence that ruxolitinib has the potential to provide myelofibrosis patients, and the physicians who treat them, a new approach to effectively manage this debilitating, life-threatening disease,” stated Paul Friedman, M.D. president and chief executive officer of Incyte. “We and Novartis will continue to work diligently to bring ruxolitinib forward as the first JAK1 and JAK2 inhibitor available to treat MF.”

Data from the COMFORT-II and COMFORT-I trials will be used for worldwide regulatory filings, planned for 2Q11 in the U.S. and the EU. Both the European Commission (EC) and the FDA have granted ruxolitinib orphan drug status for MF.