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news.Incyte has reported that a second pivotal Phase III trial of Ruxolitinib (INCB18424 or INC424) met its primary endpoint of significantly reducing spleen size in patients with myelofibrosis (MF), when compared to best available therapy.
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The safety profile of Ruxolitinib was consistent with previous studies.
Incyte said that the randomised, open-label Phase III evaluated Ruxolitinib verus best available therapy in 219 patients with primary MF, post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF).
Two-thirds of the patients received Ruxolitinib, while one-third received best available therapy, administered at doses and schedules determined by the investigator.
This trial was conducted by Novartis as part of the Incyte-Novartis worldwide partnership and license agreement for Ruxolitinib, an oral Janus kinase (JAK)1 and JAK2 inhibitor.
Results from the first and second Phase III trials will form the basis of worldwide regulatory filings, scheduled to begin in the second quarter of 2011, first in the US followed by the EU.
Both the European Commission (EC) and the US Food and Drug Administration (FDA) have granted ruxolitinib orphan drug designation for MF.