Incyte's ruxolitinib Phase III trial data on myelofibrosis presented at ASCO 2011

Incyte Corporation (Nasdaq:INCY) announced today results from the global, pivotal Phase III clinical program of ruxolitinib (INCB18424 or INC424) in patients with myelofibrosis (MF) at the 2011 American Society of Clinical Oncology (ASCO) Annual Meeting. MF is a potentially life-threatening blood cancer characterized by bone marrow failure, enlarged spleen (splenomegaly) and debilitating symptoms. MF has a poor prognosis and limited treatment options. The Phase III studies, COMFORT-I and COMFORT-II, were conducted as part of the Incyte-Novartis worldwide collaboration and license agreement for ruxolitinib, Incyte's lead oral JAK1 and JAK2 inhibitor.

Ruxolitinib-treated patients experienced significant reductions in splenomegaly and improvement in symptoms and overall quality of life measures while patients in the control arms, (placebo and best available therapy [BAT]), experienced progressive splenomegaly and worsening of symptoms.

• The COMFORT-I (COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Treatment) study met the primary efficacy endpoint, showing that 41.9% of ruxolitinib-treated patients experienced a 35% or greater reduction in spleen volume at 24 weeks as measured by magnetic resonance imaging (MRI), or computed tomography (CT), compared with 0.7% of patients in the placebo arm (p<0.0001). The vast majority of ruxolitinib-treated patients had some reduction in spleen volume with a median reduction of 33%. In addition, the COMFORT-I study showed statistically significant, clinically meaningful improvements of symptoms, a key secondary efficacy endpoint.
• The COMFORT-II study demonstrated that ruxolitinib produced a volumetric spleen size reduction of 35% or greater in 28.5% of myelofibrosis patients compared to 0% of patients in the BAT arm at 48 weeks (p<0.0001). The trial also met the key secondary endpoint, with 31.9% of ruxolitinib-treated patients demonstrating a 35% or greater volumetric spleen size reduction compared to 0% in the BAT arm at week 24 (p<0.0001). Additional data based on EORTC Quality of Life Questionnaire (EORTC QLQ-C30) scores showed a marked improvement in overall quality of life measures, functioning and symptoms relative to the BAT arm.

"The positive results seen in these two pivotal trials support ruxolitinib as an important advance for patients with myelofibrosis for which there are limited effective treatments," stated Paul Friedman, M.D., President and CEO of Incyte. "We and Novartis continue to work diligently with health authorities to bring ruxolitinib forward as the first JAK1 and JAK2 inhibitor available to treat these patients."

"In its entirety, the efficacy data from COMFORT-I and COMFORT-II have the potential to establish ruxolitinib as a new therapeutic approach by decreasing splenomegaly, itself associated with significant morbidity, and improving the symptoms that have such a profound impact on the quality of life for patients with myelofibrosis," said Srdan Verstovsek, M.D., Ph.D., Associate Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center and principal investigator for the COMFORT-I trial. "By contrast, patients treated with placebo or best available care experienced progressive splenomegaly and symptomatology."