COMFORT– I, a Pivotal Phase III Clinical Trial, to Begin in the
United States, Canada and Australia
Incyte Corporation (Nasdaq:INCY) announced today that it has reached
agreement with the U.S. Food and Drug Administration (FDA) regarding a
Special Protocol Assessment (SPA) on the design of a pivotal Phase III
trial for its lead JAK1/JAK2 Inhibitor, INCB18424, in patients with
primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis
(PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF). The
SPA provides agreement that the study design and planned analysis of the
Phase III trial adequately address objectives in support of a regulatory
submission.
COMFORT-I (COntrolled MyeloFibrosis Study with ORal
JAK Inhibitor Treatment), is a double-blind, placebo-controlled
Phase III trial comparing the efficacy and safety of INCB18424 to
placebo in approximately 240 patients with PMF, PPV-MF or PET-MF.
COMFORT-I is expected to begin in August. COMFORT-II, a second Phase III
trial being conducted in Europe, began patient enrollment in July.
Paul A. Friedman, M.D., Incyte’s President and CEO, stated,
“Finalization of the SPA is an important achievement and we look forward
to initiating COMFORT-I as quickly as possible in over 90 clinical sites
in the U.S., Canada and Australia. The primary endpoint of COMFORT-I is
the proportion of patients achieving a 35% or greater reduction in
spleen volume as compared to patients receiving placebo. Key secondary
endpoints include measuring the duration of the 35% or greater reduction
in spleen volume among the patients initially randomized to INCB18424,
and the proportion of patients who achieve a 50% or greater reduction in
symptoms as measured by a modified version of the Myelofibrosis Symptom
Assessment Form.”
Richard Levy, M.D., Incyte’s Executive Vice President, Chief Drug
Development and Medical Officer, stated, “Based on our current estimates
for patient recruitment of COMFORT-I, and assuming that results from the
trial are positive, we anticipate filing the New Drug Application for
INCB18424’s use in MF in late 2010 or early 2011.”
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 COMFORT-I
stated, “Initiation of the Phase III registration trials for INCB18424’s
use in myelofibrosis marks an important step forward in developing a new
effective treatment for this under-served disease. Importantly, the
primary and secondary endpoints in COMFORT-I and COMFORT-II are
clinically relevant features of the disease that both physicians and
patients are currently unable to overcome. I am optimistic that over
time, the results from the INCB18424 myelofibrosis Phase III program
will lead to important insights regarding the disease itself and the
long-term value of treatment with a JAK1/JAK2 inhibitor.”
COMFORT-I Trial
Overall Design: COMFORT-I (also referred to as
INCB18424-351) is a randomized (1:1), double-blind Phase III
study comparing the efficacy and safety of INCB18424 to placebo in
approximately 240 patients with PMF, PPV-MF or PET-MF.
