Incyte’s ruxolitinib COMFORT-II Phase III trial in MF meets primary endpoint

COMFORT-II, the second pivotal Phase III trial of Incyte Corporation's (Nasdaq: INCY) investigational Janus kinase (JAK) inhibitor, ruxolitinib (INCB18424 or INC424), 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, an oral JAK1 and JAK2 inhibitor.

The European study, called COMFORT-II (COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Therapy), 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, administered at doses and schedules determined by the investigator. The safety profile of ruxolitinib was consistent with previous studies. Complete study data will be submitted to an upcoming medical meeting.

"The positive results from the European COMFORT-II trial confirm the data from the US 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 CEO 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 clinical trials will form the basis of worldwide regulatory filings, planned to begin in the second quarter of 2011, first in the US followed by the EU. Both the European Commission (EC) and the United States Food and Drug Administration (FDA) have granted ruxolitinib orphan drug status for MF.

"The COMFORT-I and II trials constitute the largest clinical trial program to date in myelofibrosis. Data from these two Phase III trials demonstrate how treatment with ruxolitinib was more effective than placebo and any other available medical therapies," said Richard Levy, M.D., Executive Vice President and Chief Drug Development and Medical Officer of Incyte. "It is also very gratifying to see that the COMFORT-II safety profile is consistent with the previous studies."

Source: Incyte Corporation