- Jakafi® demonstrated superior overall
response rate in patients with steroid-refractory chronic
graft-versus-host disease (GVHD) at Week 24 compared to best
available therapy
- The study also met both key secondary
endpoints, significantly improving patient-reported symptoms and
failure-free survival
- GVHD is a serious and common complication of
allogeneic stem cell transplants with no widely approved treatment
options for patients who do not respond to steroids
Incyte (Nasdaq:INCY) today announced that the Phase 3 REACH3
study evaluating ruxolitinib (Jakafi®) in patients with moderate or
severe steroid-refractory or steroid dependent chronic
graft-versus-host disease (GVHD) met its primary endpoint of
superior overall response rate (ORR) at Week 24 compared to best
available therapy (BAT). In addition, the study also met both key
secondary endpoints, significantly improving failure-free survival
(FFS) and patient-reported symptoms assessed by the modified Lee
chronic GVHD symptom scale (mLSS).
These topline results build on previously-reported positive data
from the REACH1 and REACH2 trials, which demonstrated that Jakafi
improved outcomes across a range of efficacy measures in patients
with steroid-refractory acute GVHD. Data from the REACH3 study are
expected to be presented at an upcoming major medical congress and
will also be prepared for submission to the FDA seeking approval in
patients with steroid-refractory or steroid dependent GVHD.
“These positive results from the REACH3 study are significant as
they underscore the potential for Jakafi to provide a meaningful
treatment option, not only for patients with acute GVHD, but also
for the chronic form of the condition,” said Peter Langmuir, M.D.,
Group Vice President, Oncology Targeted Therapies, Incyte. “Based
on the outcome of this Phase 3 study, we will move forward with the
submission of these data to the U.S. FDA for this indication, which
is a critical step as we work to bring this important therapeutic
option to additional patients suffering from GVHD in the U.S.”
In 2019, Jakafi was approved by the U.S. Food and Drug
Administration for the treatment of steroid-refractory acute GVHD
in adult and pediatric patients 12 years and older, based on the
positive results of the Phase 2 REACH1 trial. Jakafi is marketed by
Incyte in the U.S.; ruxolitinib (Jakavi®) is licensed to Novartis
ex-U.S.
About REACH3
REACH3 (NCT03112603), a randomized, open-label, multicenter
Phase 3 study sponsored by Novartis and conducted in collaboration
with and co-funded by Incyte, is evaluating the safety and efficacy
of ruxolitinib compared with best available therapy in patients
with steroid-refractory chronic GVHD.
The primary endpoint was overall response rate (ORR) at Day 1 of
the Cycle 7 (Day 168) visit, defined as the percentage of
participants demonstrating a complete or partial response.
Secondary endpoints include change in the modified Lee chronic GVHD
symptom scale score at Day 1 of Cycle 7, rate of failure-free
survival (FFS) up to 36 months, best overall response (BOR),
duration of response (DoR), overall survival (OS), among others.
For more information about the study, please visit
https://clinicaltrials.gov/ct2/show/NCT03112603.
About REACH
The REACH clinical trial program evaluating ruxolitinib in
patients with steroid-refractory GVHD includes the randomized
pivotal Phase 3 REACH2 and REACH3 trials, conducted in
collaboration with Novartis.
The REACH program was initiated with the Incyte-sponsored REACH1
trial, a prospective, open-label, single-cohort, multicenter,
pivotal Phase 2 trial (NCT02953678) evaluating Jakafi in
combination with corticosteroids in patients with
steroid-refractory grade II-IV acute GVHD. For more information
about the study, including trial results, please visit
https://clinicaltrials.gov/show/NCT02953678.
About Jakafi® (ruxolitinib)
Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the
U.S. FDA for the treatment of polycythemia vera (PV) in adults who
have had an inadequate response to or are intolerant of
hydroxyurea, in adults with intermediate or high-risk myelofibrosis
(MF), including primary MF, post-polycythemia vera MF and
post-essential thrombocythemia MF and for the treatment of
steroid-refractory acute GVHD in adult and pediatric patients 12
years and older.
Jakafi is marketed by Incyte in the United States and by
Novartis as Jakavi® (ruxolitinib) outside the United States. Jakafi
is a registered trademark of Incyte Corporation. Jakavi is a
registered trademark of Novartis AG in countries outside the United
States.
Important Safety Information
Jakafi can cause serious side effects, including:
Low blood counts: Jakafi® (ruxolitinib) 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 develop or have worsening symptoms such as unusual
bleeding, bruising, tiredness, shortness of breath, or a fever.
Infection: You may be at risk for developing a serious
infection during treatment with Jakafi. Tell your healthcare
provider if you develop any of the following symptoms of infection:
chills, nausea, vomiting, aches, weakness, fever, painful skin rash
or blisters.
Skin cancers: Some people who take Jakafi have developed
certain types of non-melanoma skin cancers. Tell your healthcare
provider if you develop any new or changing skin lesions.
Increases in cholesterol: You may have changes in your
blood cholesterol levels. Your healthcare provider will do blood
tests to check your cholesterol levels during your treatment with
Jakafi.
The most common side effects of Jakafi include: for
certain types of MF and PV - low platelet or low red blood cell
counts, bruising, dizziness, headache, and diarrhea; and for acute
GVHD – low platelet, red or white blood cell counts, infections,
and fluid retention.
These are not all the possible side effects of Jakafi. Ask your
pharmacist or healthcare provider 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 tuberculosis (TB), or have been in
close contact with someone who has TB, have or had hepatitis B,
have or had liver or kidney problems, are on dialysis, have a high
level of fat in your blood (high blood cholesterol or
triglycerides), had skin cancer or have any other medical
condition. Take Jakafi exactly as your healthcare provider tells
you. Do not change or stop taking Jakafi without first talking to
your healthcare provider.
Women should not take Jakafi while pregnant or planning to
become pregnant. Do not breast-feed during treatment with Jakafi
and for 2 weeks after the final dose.
Full Prescribing Information, which includes a more complete
discussion of the risks associated with Jakafi, is available at
www.jakafi.com.
About Incyte
Incyte is a Wilmington, Delaware-based, global biopharmaceutical
company focused on finding solutions for serious unmet medical
needs through the discovery, development and commercialization of
proprietary therapeutics. For additional information on Incyte,
please visit Incyte.com and follow @Incyte.
Forward-Looking Statements
Except for the historical information set forth herein, the
matters set forth in this press release, including statements about
the timing of the presentation of the REACH3 data, whether and when
such data will be submitted to the FDA, approved by the FDA as a
treatment for moderate or severe steroid-refractory or steroid
dependent chronic GVHD or commercialized in the U.S. or elsewhere,
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: unanticipated
delays; further research and development and the results of
clinical trials possibly being unsuccessful or insufficient to meet
applicable regulatory standards or warrant continued development;
the ability to enroll sufficient numbers of subjects in clinical
trials; determinations made by the FDA; the Company’s dependence on
its relationships with its collaboration partners; the efficacy or
safety of the Company’s products and the products of the Company’s
collaboration partners; the acceptance of the Company’s products
and the products of the Company’s collaboration partners in the
marketplace; market competition; sales, marketing, manufacturing
and distribution requirements; greater than expected expenses;
expenses relating to litigation or strategic activities; 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 March 31, 2020. The Company disclaims
any intent or obligation to update these forward-looking
statements.
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Incyte Media Catalina
Loveman +1 302 498 6171 cloveman@incyte.com Investors
Michael Booth, DPhil +1 302 498 5914 mbooth@incyte.com
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