Incyte Corporation will present updated results from an ongoing Phase II trial of INCB18424, its selective, orally available Janus kinase (JAK) inhibitor, in patients with myelofibrosis (MF) at the 50th American Society of Hematology (ASH) Annual Meeting.
MF is a serious neoplastic condition characterized by varying degrees of bone marrow failure, splenic enlargement and debilitating constitutional symptoms resulting in a significant loss in quality of life and reduced life-span. There are currently no approved treatments for patients with myelofibrosis.
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 Phase II trial, stated, “Over the past 18 months, nearly 150 MF patients have been enrolled in the Phase II trial, INCB18424-251. Important and previously unachievable clinical benefits observed in this study include striking improvement in splenomegaly and the debilitating constitutional symptoms that plague the majority of these patients. INCB18424 treatment improves the systemic inflammatory state which we know characterizes advanced MF. INCB18424 results in prompt and sustained reductions in the markedly elevated levels of a broad range of pro-inflammatory cytokines that we have now documented in MF patients. Additionally, regardless of an MF patient's diagnostic subgroup or the presence or absence of JAK2 mutations which occur in subsets of MF patients, the vast majority of patients entering this trial remain on study, many for a year or more, with durable and robust clinical benefit.”
Richard Levy, M.D., Incyte's Senior Vice President, Drug Development, added, “The updated data set, much of which will be summarized at ASH, confirms that long term INCB18424 treatment has been well tolerated and results in durable clinical improvement in splenomegaly, constitutional symptoms, and cachexia. New data also demonstrate improvement in exercise tolerance and confirmation of spleen size reduction as measured by MRI. Importantly, this clinical experience gives us the confidence to select registration endpoints and the dosing regimen for the Phase III program which we expect will support US and international registrations. We plan to start Phase III in the first half of 2009 following FDA approval of a special protocol assessment.”
The most current data from the ongoing Phase II trial will be described in four posters to be presented at the ASH meeting (to access copies of these posters, please go to: http://library.corporate-ir.net/library/69/697/69764/items/317459/INCY_ASH2008.pdf
# 1760: INCB018424, a Selective JAK1/2 Inhibitor, Significantly Improves the Compromised Nutritional Status and Frank Cachexia in Patients with Myelofibrosis (MF)
Ruben A. Mesa, MD, FACP, Srdan Verstovsek, Hagop M. Kantarjian, MD, Animesh D. Pardanani, MBBS, PhD, Steven Friedman, MD, Robert Newton, Susan Erickson-Viitanen, Deborah Hunter, John Redman, MD, Swamy Yeleswaram, Edward Bradley, MD and Ayalew Tefferi, MD
# 1762: The JAK Inhibitor, INCB018424, Demonstrates Durable and Marked Clinical Responses in Primary Myelofibrosis (PMF) and Post-Polycythemia Vera/Essential Thrombocythemia Myelofibrosis (Post PV/ET-MF)
Srdan Verstovsek, Hagop M. Kantarjian, MD, Animesh D. Pardanani, MBBS, PhD, Deborah Thomas, MD, Jorge Cortes, MD, Ruben A. Mesa, MD, FACP, William J.Hogan, MBChB, John R. Redman, MD, Sue Erickson-Viitanen, Richard Levy, MD, Kris Vaddi, PhD, DVM, Edward Bradley, MD, Jordan Fridman, PhD and Ayalew Tefferi, MD
# 2804: The Clinical Phenotype of Myelofibrosis Encompasses a Chronic Inflammatory State that is Favorably Altered by INCB018424, a Selective Inhibitor of JAK1/2
Ayalew Tefferi, MD, Hagop M Kantarjian, Animesh D. Pardanani, MBBS, PhD, Ruben A. Mesa, MD, FACP, Robert C Newton, PhD, Peggy A Scherle, PhD, Timothy Burn, PhD and Srdan Verstovsek
# 2802: Characterization of JAK2 V617F Allele Burden in Advanced Myelofibrosis (MF) Patients: No Change in V617F:WT JAK2 Ratio in Patients with High Allele Burdens despite Profound Clinical Improvement Following Treatment with the JAK Inhibitor, INCB018424
Srdan Verstovsek, MD, PhD, Hagop M. Kantarjian, MD, Animesh D. Pardanani, MBBS, PhD, Timothy Burn, PhD, Kris Vaddi, PhD, DVM, John Redman, MD, Edward C Bradley, MD, Richard Levy, MD, Steven Friedman, MD, Gregory Hollis, PhD and Ayalew Tefferi, MD
Phase II Study Design