Incyte announces additional results from ruxolitinib Phase III trial on myelofibrosis

Incyte Corporation (Nasdaq:INCY) announced today additional symptom improvement and quality of life (QoL) results from COMFORT-I (COntrolled MyeloFibrosis Study with ORal JAK inhibitor Treatment), a randomized, double-blinded, placebo-controlled Phase III trial of Incyte's JAK1 and JAK2 inhibitor, ruxolitinib, in patients with myelofibrosis (MF). The data, being reported at the 16th EHA Congress today, demonstrated that treatment with ruxolitinib resulted in significant reductions in spleen volume and improvements in Total Symptom Score (TSS) while placebo-treated patients experienced progressive splenomegaly (enlarged spleen) and worsening of symptoms, complementing clinical results presented recently at the 2011 ASCO Annual Meeting.

The findings are being reported at the EHA Congress in Poster #0912: Results Using the Modified Myelofibrosis Symptom Assessment Form (MFSAF v2.0) in COMFORT-I: a Randomized, Double-Blind, Phase III Trial of JAK1/2 Inhibitor Ruxolitinib vs. Placebo in Myelofibrosis. The presenting author is Ruben A. Mesa, M.D., Professor of Medicine, Chair, Division of Hematology & Medical Oncology, Mayo Clinic, Arizona. Dr. Mesa is a leading expert on the symptomatic burden of myelofibrosis and has been instrumental in developing tools, such as the modified MFSAF, for measuring these symptoms.

These data demonstrated that the primary endpoint of a 35% reduction in spleen volume was clearly associated with reduction of abdominal symptoms (abdominal discomfort, pain under the ribs and feeling of fullness (early satiety)) associated with an enlarged spleen. Importantly, many patients with less than 35% reduction in spleen volume also had meaningful improvement in abdominal symptoms. Patient benefit also was assessed using the Patient Global Impression of Change (PGIC), which measures patients' global assessment of change in their condition on a 7-point scale ranging from "very much worse" to "very much improved." While more than two-thirds of ruxolitinib-treated patients graded their disease as "much or very much improved" based on the PGIC, nearly three-quarters of placebo-treated patients reported "no change" or "worsening" on that scale.

In addition, of patients who had a 50% or greater reduction in TSS (a key secondary endpoint), nearly 90% rated their disease as "much or very much improved" based on the PGIC scale. Also, over 50% of patients with a 25% to 50% TSS improvement rated their disease as "much or very much improved," indicating that a significant proportion of these ruxolitinib-treated patients also had meaningful improvement in their disease. Associated with these improvements were improvements in almost all sub-scales of the European Organization for Research and Treatment of Cancer Quality-of-Life 30 Questionnaire (EORTC QLQ-C30), a standard and well-validated measure of quality of life in cancer patients. A copy of the poster presentation can be viewed by clicking on the following link: EHA 2011 Ruben Mesa Poster.

Richard Levy, M.D., Incyte's Executive Vice President and Chief Drug Development and Medical Officer, stated, "Quality of life in patients with myelofibrosis can be severely compromised by massive splenomegaly and debilitating symptoms, and it is highly gratifying to see profound symptomatic improvement resulting in improved quality of life in MF patients."

As expected based on the mechanism of action of ruxolitinib, the most common adverse events occurring more frequently on ruxolitinib treatment than on placebo were anemia and thrombocytopenia. Both were manageable as evidenced by the low discontinuation rate as a result of these events (1 patient for each event in each arm of the study). Thrombocytopenia was managed with dose modifications and anemia was generally managed with transfusion. The prevalence of grade 3 and 4 anemia in ruxolitinib patients diminished over time as did the need for transfusion. Among the most frequently reported non-hematologic adverse events in ruxolitinib treated patients were dizziness, headache and bruising and were generally of low grade, and self limited with continued therapy.

Source: Incyte Corporation