Incyte Corporation (Nasdaq: INCY) announced today that the Phase 2
sub-study of ruxolitinib or placebo in combination with regorafenib in
patients with relapsed or refractory metastatic colorectal cancer (CRC)
and high C-reactive protein (CRP) will be stopped early. The decision to
stop the sub-study was made after a planned interim analysis of the high
CRP subgroup demonstrated that ruxolitinib plus regorafenib did not show
a sufficient level of efficacy to warrant continuation.
“We are disappointed at the outcome from this interim analysis and
deeply grateful for the support and commitment of the patients
participating in the study, their families, and the study
investigators,” said Steven Stein, M.D., Chief Medical Officer of Incyte.
About the Study
This Phase 2 randomized, double-blind study (INCB 18424-267) of patients
with relapsed or refractory metastatic CRC included an open-label,
safety run-in, to confirm the safety of the ruxolitinib plus regorafenib
combination in subjects with relapsed or refractory metastatic CRC as
well as a randomized phase of the study. The randomized phase of the
study included 2 sub-studies targeting separate populations of patients
with CRC based on levels of systemic inflammation, as measured by the
modified Glasgow Prognostic Score (sub-study 1 CRP >10 mg/L and
sub-study 2 CRP ≤ 10 mg/L). Patients in each sub-study were randomized
1:1 to receive ruxolitinib plus regorafenib or regorafenib plus placebo.
About Ruxolitinib (Jakafi®)
Ruxolitinib (Jakafi) is a first-in-class JAK1/JAK2 inhibitor approved by
the U.S. Food and Drug Administration for treatment of people with
polycythemia vera (PV) who have had an inadequate response to or are
intolerant of hydroxyurea. Jakafi is also indicated for treatment of
people with intermediate or high-risk myelofibrosis (MF), including
primary MF, post–polycythemia vera MF, and post–essential
thrombocythemia MF.
Ruxolitinib is not approved anywhere in the world as treatment for
metastatic colorectal cancer.
Full Prescribing Information, including a more complete discussion of
the risks associated with Jakafi, is available at www.jakafi.com.
Jakafi is marketed by Incyte in the United States and by Novartis as
Jakavi® (ruxolitinib) outside the United States.
About Incyte
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical
company focused on the discovery, development and commercialization of
proprietary therapeutics, primarily for oncology. For additional
information on Incyte, please visit the Company’s website at www.incyte.com.
Forward Looking Statements
Except for the historical information set forth herein, the matters set
forth in this press release contain predictions, estimates and other
forward-looking statements. These forward-looking statements are based
on the Company’s current expectations and subject to risks and
uncertainties that may cause actual results to differ materially,
including unanticipated developments in and risks related to the
efficacy or safety of any of the product candidates in the Company’s
development portfolio, the results of further research and development,
the high degree of risk and uncertainty associated with drug
development, clinical trials and regulatory approval processes, the
risks that results of clinical trials may be unsuccessful or
insufficient to meet applicable regulatory standards, the ability to
enroll sufficient numbers of subjects in clinical trials, other market,
economic or strategic factors and technological advances, unanticipated
delays, the ability of the Company to compete against parties with
greater financial or other resources, risks associated with the
Company's dependence on its relationships with its collaboration
partners, and other risks detailed from time to time in the Company’s
reports filed with the Securities and Exchange Commission, including its
Form 10-Q for the quarter ended September 30, 2015. The Company
disclaims any intent or obligation to update these forward-looking
statements.
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