Incyte's INCB18424 provides previously unachievable clinical benefits in myelofibrosis patients

Dec 7 2009

Incyte Corporation (NASDAQ: INCY) announced this morning that INCB18424 (also referred to as INCB018424), its selective, orally available janus kinase (JAK) inhibitor, will be the subject of three oral presentations at the 51^st American Society of Hematology (ASH) Annual Meeting in New Orleans.

Srdan Verstovsek, M.D., Ph.D., Associate Professor, Leukemia Department, Myeloproliferative Disorders Program Leader, University of Texas M.D. Anderson Cancer Center, and the principal investigator for the INCB18424 myeloproliferative neoplasms clinical programs, stated, "INCB18424 continues to provide durable and previously unachievable clinical benefits in patients with myelofibrosis with or without JAK2 activating mutations. It is equally gratifying to see significant clinical benefits in patients with advanced polycythemia vera and essential thrombocythemia including normalization of blood counts, normalization of hematocrit without the need for phlebotomy, rapid and durable reductions in enlarged spleens as well as rapid and durable reductions in symptoms, particularly pruritus.

“Additionally, in an exploratory trial in highly refractory patients with secondary acute myeloid leukemia and other leukemias for which no standard therapies are likely to lead to a durable remission, it is encouraging to see patients obtain clinical benefit including the achievement of stable disease as well as complete and partial responses. Our experience with INCB18424 in these highly refractory leukemia patients, along with the growing body of evidence indicating that JAK activation may play a determining role in a number of hematologic malignancies, suggests that use of a selective JAK inhibitor may help provide underserved patients in multiple hematological cancers with improved clinical outcomes.”

Richard Levy, M.D., Incyte's Executive Vice President, Chief Drug Development and Medical Officer, added, "The updated data from the Phase II trial in myelofibrosis, our most advanced program for INCB18424, demonstrate that the dosing regimens that are being used in our Phase III trials, COMFORT-I and COMFORT-II, have the potential to be well tolerated and provide durable clinical improvement in both splenomegaly and the debilitating constitutional symptoms seen in the majority of MF patients.

“COMFORT-I and II are currently enrolling patients diagnosed with myelofibrosis, either primary myelofibrosis or post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis, regardless of the presence or absence of the JAK V617F mutation. Additionally, in both studies, patients not randomized to receive INCB18424 will have the opportunity to cross over to receive this investigational therapy.”