Novartis JAK inhibitor INC424 shows significant clinical benefit for myelofibrosis patients in two Phase III studies at ASCO
Novartis announced today results from two pivotal Phase III studies demonstrating the effects of investigational Janus kinase (JAK) inhibitor INC424 (ruxolitinib) in treating patients with myelofibrosis, a blood cancer with limited treatment options.
- (1888PressRelease) June 06, 2011 - These data are being presented at the 47th American Society of Clinical Oncology (ASCO) annual meeting in Chicago[1],[2],[3]. Novartis and Incyte have a worldwide collaboration and license agreement for INC424.
Myelofibrosis is a life-threatening blood cancer characterized by bone marrow failure, enlarged spleen and debilitating symptoms, including fatigue and pain
Phase III trial (COMFORT-II) demonstrated INC424 significantly reduced enlarged spleen size, a major characteristic of the disease, when compared to best available therapy at 48 weeks
A separate Phase III trial (COMFORT-I) of INC424 showed significant spleen size reduction and symptom improvement when compared to placebo at 24 weeks
Both studies met their primary endpoint and provide the basis for worldwide filings to begin in Q2 2011 in myelofibrosis, for which there are limited treatment options
The Phase III trial COMFORT-II (COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Therapy) demonstrated that INC424 produced a volumetric spleen size reduction of 35% or greater in 28.5% of myelofibrosis patients compared to 0% of patients in the best available therapy arm at 48 weeks (p
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