Incyte Provides Top-Line Results from Phase II Proof-of-Concept Trial of Ruxolitinib in Patients with Refractory Metastatic

  Incyte Provides Top-Line Results from Phase II Proof-of-Concept Trial of
  Ruxolitinib in Patients with Refractory Metastatic Pancreatic Cancer

  *Overall survival analysis demonstrated a hazard ratio of 0.79 and a
    pre-specified subgroup analysis achieved a significant benefit with a
    hazard ratio of 0.47
  *Results expected to define and support a pivotal registration program in
    metastatic pancreatic cancer

Business Wire

WILMINGTON, Del. -- August 21, 2013

Incyte Corporation (Nasdaq: INCY) announced top-line results of the Phase II,
randomized, double-blind, placebo-controlled RECAP trial of ruxolitinib, its
oral JAK1 and JAK2 inhibitor, in combination with capecitabine in patients
with recurrent or treatment refractory metastatic pancreatic cancer. The
hazard ratio (HR) for overall survival (OS) in the intent to treat population
was 0.79 (one-sided p=0.12), and in a pre-specified subgroup analysis
conducted in patients identified prospectively as most likely to benefit from
JAK pathway inhibition, the HR for OS was 0.47 (one-sided p=0.005). Within
this subgroup of patients, which represented 50% of the randomized population,
6 month survival in the ruxolitinib arm was 42% vs. 11% for placebo. Durable
tumor responses were only observed in patients receiving ruxolitinib, and
ruxolitinib treated patients achieved a significant improvement in body weight
relative to placebo.

“Results of the RECAP trial provide the first evidence that JAK inhibition is
active in this disease and suggest a demonstrable survival benefit in a
well-defined group of patients with refractory metastatic pancreatic cancer
who can be identified without the development of a companion diagnostic test.
Coupled with the overall survival benefit observed in the ongoing Phase III
trials in myelofibrosis, these results solidify our belief in the therapeutic
opportunity that exists for Jakafi, and provide us with an acceleration
strategy to advance our JAK1 inhibitor portfolio into additional areas of
unmet medical need,” stated Paul A. Friedman, M.D., Incyte’s President and
Chief Executive Officer.

Richard S. Levy, Incyte’s Executive Vice President and Chief Drug Development
and Medical Officer added, “Advanced pancreatic cancer is a devastating
disease, and the RECAP study has provided us with a unique opportunity to
bring ruxolitinib forward into Phase III development in a population with no
attractive treatment options. We look forward to working with the FDA to
define the core components of the Phase III program in pancreatic cancer as
rapidly as possible, and in parallel, leveraging these results to expand our
ruxolitinib and JAK1 inhibitor programs into additional solid tumor
populations, including those that may benefit from selective JAK1 inhibition.”

Full results of the RECAP trial are expected to be presented at a future
scientific meeting.

Safety

Ruxolitinib in combination with capecitabine was generally well tolerated in
this study. Among patients receiving ruxolitinib plus capecitabine 12%
discontinued therapy for an adverse event, compared with 20% who received
capecitabine alone. The rates of new onset grade 3 anemia, thrombocytopenia or
neutropenia were 16%, 2% and 0%, respectively, among patients receiving
ruxolitinib plus capecitabine and were 2%, 3% and 2%, respectively, among
patients receiving capecitabine alone.

About The RECAP Trial

The purpose of this initial proof-of-concept study was to determine whether
ruxolitinib in combination with capecitabine could improve the overall
survival of patients with refractory metastatic pancreatic cancer as compared
to capecitabine alone. RECAP included pre-specified analyses to determine the
base line characteristics of patients most likely to benefit from treatment
with ruxolitinib. The study included a total of 136 patients and consisted of
an open-label, safety run-in period involving nine patients to determine the
safety of the ruxolitinib and capecitabine combination. This was followed by a
double-blind study of 127 patients randomized 1 to 1 to capecitabine plus
ruxolitinib or capecitabine plus placebo. Patients received treatment as long
as the regimen was tolerated or the patient did not meet any of the
discontinuation criteria. In the event of disease progression, capecitabine
therapy was discontinued while treatment with ruxolitinib or placebo continued
unless patients withdrew consent for further participation in the trial. In
addition to the primary endpoint of overall survival, secondary endpoints
included progression free survival, body weight and nutritional markers, tumor
response rate, quality of life outcomes and pain status.

About Pancreatic Cancer

Pancreatic cancer is the fourth leading cause of cancer-related death in the
US and the eighth leading cause of cancer-related death worldwide. For
patients with advanced pancreatic cancer, the 5-year overall survival rate is
less than 1 percent. Most patients die within the first year. Pancreatic
cancer has the lowest 5-year overall survival rate of any cancer in the US. In
Europe, the reported survival rate is less than 10 percent survival at five
years. Unfortunately, most patients do not exhibit symptoms until their
disease is advanced. Additionally, pancreatic cancer progresses and
metastasizes rapidly, highlighting the need to identify high-risk candidates
early.

About Ruxolitinib

Ruxolitinib is an oral, selective inhibitor of Janus kinases 1 and 2 (JAK1 and
JAK2). Ruxolitinib, brand name Jakafi^®, is indicated for treatment of
patients with intermediate or high-risk myelofibrosis (MF), including primary
MF, post-polycythemia vera MF and post-essential thrombocythemia MF.
Thislife-threatening blood cancer is characterized by bone marrow failure,
enlarged spleen (splenomegaly) and debilitating symptoms.

Important Safety Information

Jakafi can cause serious side effects including:

Low blood counts: Jakafi may cause your platelet, red blood cell, or white
blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi
and call your healthcare provider. Your healthcare provider will perform blood
tests to check your blood counts before you start Jakafi and regularly during
your treatment. Your healthcare provider may change your dose of Jakafi or
stop your treatment based on the results of your blood tests. Tell your
healthcare provider right away if you experience unusual bleeding, bruising,
fatigue, shortness of breath, or a fever.

Infection: You may be at risk for developing a serious infection while taking
Jakafi. Tell your healthcare provider if you develop symptoms such as chills,
nausea, vomiting, aches, weakness, fever, or painful skin rash or blisters.

The most common side effects of Jakafi include dizziness and headache.

These are not all the possible side effects of Jakafi. Ask your healthcare
provider or pharmacist for more information. Tell your healthcare provider
about any side effect that bothers you or that does not go away.

Before taking Jakafi, tell your healthcare provider about all the medications,
vitamins, and herbal supplements you are taking and all your medical
conditions, including if you have an infection, have or had liver or kidney
problems, are on dialysis, or have any other medical condition. Do not drink
grapefruit juice while taking Jakafi.

Women should not take Jakafi while pregnant or planning to become pregnant, or
if breast-feeding.

Please see the Full Prescribing Information available at www.jakafi.com, which
includes a more complete discussion of the risks associated with Jakafi.

About Incyte

Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company
focused on the discovery, development and commercialization of proprietary
small molecule drugs for oncology and inflammation. 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, including without limitation, statements as to results
of the RECAP trial being expected to define and support a pivotal registration
program for ruxolitinib in metastatic pancreatic cancer, that results of the
RECAP trial suggest a demonstrable survival benefit in a well-defined group of
patients with refractory metastatic pancreatic cancer who can be identified
without the development of a companion diagnostic test, our plans to work with
the FDA to define the core components of the Phase III program in pancreatic
cancer as rapidly as possible and to expand and advance our JAK1 program into
additional solid tumor populations that may benefit from selective JAK1
inhibition and areas of unmet medical need, and our expectation that full
results of the RECAP trial will be presented at a future scientific meeting,
contain predictions, estimates and other forward-looking statements.

These forward-looking statements are based on Incyte’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 ruxolitinib, risks related to market competition, the
results of further research and development, 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 or economic factors and technological advances,
unanticipated delays, the ability of Incyte to compete against parties with
greater financial or other resources, and other risks detailed from time to
time in Incyte’s reports filed with the Securities and Exchange Commission,
including our Form 10-Q for the quarter ended June 30, 2013.

Incyte disclaims any intent or obligation to update these forward-looking
statements.

Contact:

Incyte Corporation
Pamela M. Murphy
Vice President, Investor Relations & Corporate Communications
302-498-6944
 
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