- Improvement in mortality for each dose
compared to placebo, while trending toward positive, was not
statistically significant for the overall study population
- Significant improvement in mortality seen in
U.S. study participants at both doses, and in the overall
population when data from both treatment arms was pooled
- Expanded Access Program to allow eligible
patients in the United States with COVID-19 associated ARDS to
receive ruxolitinib will be discussed with the U.S. Food and Drug
Administration
Incyte (Nasdaq:INCY) today announced results from the Phase 3
DEVENT study evaluating the efficacy and safety of ruxolitinib (5mg
and 15mg) plus standard of care (SoC) versus SoC in patients on
mechanical ventilation with COVID-19 associated Acute Respiratory
Distress Syndrome (ARDS), a type of respiratory failure
characterized by rapid onset of widespread inflammation in the
lungs.
While results indicate a trend towards an improvement in
mortality in the overall study population (N=211), the DEVENT study
did not meet its primary endpoint—mortality due to any cause
through day 29—adjusted for ARDS severity between the two treatment
arms versus placebo (55.2% vs. 74.3% [Odds Ratio (OR): 0.42 (95%
CI: 0.171-1.023)], P=0.0280 in the 5mg arm and 51.8% vs. 69.6% [OR:
0.46 (95% CI: 0.201-1.028)], P=0.0292 in the 15mg arm). In the U.S.
study population (N=191), which accounts for the majority (91%) of
the DEVENT study patients, there was a clinically and statistically
significant improvement in mortality in each of the 5mg (46.7% vs.
69.1% [OR: 0.39 (95% CI: 0.157-0.948)], P=0.0189) and 15mg
treatment arms (47.1% vs. 66.7% [OR: 0.43 (95% CI: 0.188-0.974)],
P=0.0215) versus placebo, respectively. Additionally, a post-hoc
analysis of the overall study population pooling both the 5mg and
15mg ruxolitinib arms together versus placebo, showed a
statistically significant improvement in mortality (53.6% vs. 70.7%
[OR: 0.47 (95% CI: 0.219-0.996)], P=0.0244). More than half of
study patients (55%) received remdesivir and 90% of study patients
received corticosteroids prior to or during the study.
The safety profile was generally consistent with hospitalized
patients with COVID-19 and consistent with treatment with
ruxolitinib. The most common adverse events on the ruxolitinib
arms, regardless of dose, compared to placebo were anemia (20.7%
vs. 22.2%), increased alanine aminotransferase (ALT, 14.6% vs.
13.3%), increased aspartate transaminase (AST, 14.0% vs. 8.9%) and
hypertension (11.6% vs. 11.1%), respectively.
“There remains a significant unmet medical need for treatments
that may potentially improve survival outcomes for patients
suffering from severe COVID-19 related complications, specifically
those requiring mechanical ventilation,” said Steven Stein, M.D.,
Chief Medical Officer, Incyte. “We hope the results of this study,
and the potential utility of ruxolitinib for treatment of patients
with severe COVID-19 associated ARDS, will contribute to the
advances being made across the scientific community to alleviate
the burden this pandemic has placed on patients, as well as the
healthcare system. We look forward to discussing the results of the
DEVENT study with regulatory authorities in the United States.”
Given the urgent nature of the COVID-19 pandemic, Incyte plans
to make ruxolitinib available to eligible patients in the United
States at no cost via an Expanded Access Program (EAP) pending
agreement with the U.S. Food and Drug Administration. The protocol
will allow eligible patients with severe COVID-19 associated ARDS
with disease severity requiring mechanical ventilation to receive
ruxolitinib.
At present, there is ample commercial and clinical supply of
ruxolitinib in the United States to meet the needs of U.S. patients
receiving ruxolitinib in its approved indications and those
participating in clinical trials or the COVID-19 EAP.
For more information about Incyte’s response to COVID-19,
including information on the DEVENT study and EAP, visit:
Incyte.com/COVID-19.
About DEVENT (NCT04377620)
A Phase 3 randomized, double-blind, placebo-controlled,
multicenter clinical trial, the DEVENT study evaluated the efficacy
and safety of ruxolitinib 5mg and 15mg plus standard of care (SoC)
compared to SoC plus placebo in patients with COVID-19 associated
acute respiratory distress syndrome (ARDS) on mechanical
ventilation. At initiation, the study aimed to enroll 500 patients;
in December 2020, enrollment was stopped and the final analysis was
conducted at the time of the planned interim analysis.
The primary endpoint of the study evaluated the mortality rate
at day 29 of ruxolitinib 5mg twice daily (BID) plus SoC therapy and
ruxolitinib 15mg BID plus SoC compared with placebo plus SoC, in
participants with COVID-19 associated ARDS who required mechanical
ventilation. Secondary outcomes measures included number of days
patients were ventilator free, did not receive supplemental oxygen,
did not use vasopressor therapy, as well as the number of days
patients were out of the hospital, clinical status at Day 15 and 29
using the COVID-19 ordinal scale, change in organ function or rate
of failure (as measured by Sequential Organ Failure Assessment or
SOFA Score) and safety.
For more information about DEVENT, please visit:
https://www.clinicaltrials.gov/ct2/show/NCT04377620.
About the Ruxolitinib Expanded Access Program (EAP) in
COVID-19
The ruxolitinib Expanded Access Program (EAP) in COVID-19 will
provide eligible patients with severe COVID-19 associated ARDS to
receive ruxolitinib at no cost.
For more information, please visit Incyte.com/COVID-19.
Questions or inquiries regarding the EAP or independent research
should be made to:
U.S. Medical Information 1-855-4MED-INFO (1-855-463-3463)
medinfo@incyte.com
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
regarding the Company’s ongoing clinical development program for
ruxolitinib in patients with COVID-19, the enrollment, design,
timing, efficacy and results of the DEVENT clinical trial program
or any EAP study, whether ruxolitinib will become an approved or
effective treatment option for any patients with COVID-19
infection, and whether commercial and clinical supply of
ruxolitinib in the U.S. will continue to be sufficient to meet the
current needs, 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: developments
relating to the COVID-19 pandemic in the U.S. and around the world;
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 or
other regulators; 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-K for the year ended
December 31, 2020. The Company disclaims any intent or obligation
to update these forward-looking statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20210318005781/en/
Media Catalina Loveman +1 302 498 6171
cloveman@incyte.com
Jenifer Antonacci +1 302 498 7036 jantonacci@incyte.com
Investors Christine Chiou +1 302 274-4773
cchiou@incyte.com
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