Incyte Announces Results of Phase 3 Study of Itacitinib in Patients with Treatment-Naïve Acute Graft-Versus-Host Disease
January 02 2020 - 4:30PM
Business Wire
- GRAVITAS-301 results show that treatment with
itacitinib in combination with corticosteroids did not
statistically improve overall response rate or non-relapse
mortality compared to placebo plus corticosteroids
- Conference call scheduled today at 5:00 p.m.
ET
Incyte Corporation (Nasdaq:INCY) today announced that the
pivotal Phase 3 GRAVITAS-301 study evaluating itacitinib in
combination with corticosteroids in patients with treatment-naïve
acute graft-versus-host disease (GVHD) did not meet the primary
endpoint of improving overall response rate (ORR) at Day 28
compared to placebo plus corticosteroids (74.0 percent vs. 66.4
percent, p=0.08, respectively). Itacitinib added to corticosteroids
improved the overall response rate in patients with treatment-naïve
acute GVHD; however, the difference versus placebo plus
corticosteroids was not statistically significant. In addition,
there was no difference observed in non-relapse mortality (NRM) at
Month 6, the study’s key secondary endpoint, between the treatment
and placebo arms.
The safety profile observed in GRAVITAS-301 was consistent with
that observed in previously reported studies of itacitinib in
combination with corticosteroids. The most common adverse events
were thrombocytopenia (34.9 percent for itacitinib and 34.7 percent
for placebo) and anemia (29.8 percent for itacitinib and 25.0
percent for placebo).
“The result of this study is disappointing. However, we remain
committed to building on the success of the REACH program for
ruxolitinib, which showed positive results in steroid refractory
acute GVHD. Additionally we will continue to study the role of JAK
inhibition in chronic GVHD and in the prophylactic setting, as we
seek to develop treatments for patients with this debilitating and
often fatal disease,” said Steven Stein, M.D., Chief Medical
Officer, Incyte.
Incyte will inform investigators of the results and work with
them to appropriately conclude the study in a manner consistent
with the best interest of each patient. Data from this study will
be submitted for presentation at an upcoming scientific
meeting.
About GRAVITAS-301
GRAVITAS-301 (NCT03139604) is a randomized, double-blind,
placebo-controlled pivotal Phase 3 study evaluating itacitinib or
placebo, in combination with corticosteroids, as a first-line
treatment for patients with acute GVHD. The primary endpoint is
overall response rate (ORR) at Day 28, defined as the proportion of
subjects demonstrating a complete response, very good partial
response, or partial response. The key secondary endpoint is
non-relapse mortality at Month 6, defined as the proportion of
subjects who died due to causes other than malignancy relapse.
Other secondary endpoints include duration of response. For more
information about the study, please visit
https://clinicaltrials.gov/ct2/show/NCT03139604?term=gravitas&rank=2.
About Itacitinib
Itacitinib (INCB039110) is a novel and selective JAK1 inhibitor
currently in clinical studies for the first-line treatment of
patients with acute and chronic GVHD.
Itacitinib was discovered at Incyte, and Incyte holds the global
development and commercialization rights for itacitinib with the
exception of China, where the rights to develop and commercialize
itacitinib have been licensed to Innovent Biologics, Inc.
Conference Call Information
Incyte will host a conference call at 5:00 p.m. ET on January 2,
2020. To access the conference call, please dial 877-407-3042 for
domestic callers or 201-389-0864 for international callers. When
prompted, provide the conference identification number,
13697736.
If you are unable to participate, a replay of the conference
call will be available for 30 days. The replay dial-in number for
the United States is 877-660-6853 and the dial-in number for
international callers is 201-612-7415. To access the replay you
will need the conference identification number, 13697736.
The conference call will also be webcast live and can be
accessed at www.incyte.com in the Investors section under “Events
and Presentations.”
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 presentation of data from the Company’s ongoing
clinical development program for itacitinib, development plans for
ruxolitinib and further development in GVHD, 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 September 30, 2019. The Company
disclaims any intent or obligation to update these forward-looking
statements.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200102005480/en/
Media Catalina Loveman +1 302 498 6171
cloveman@incyte.com
Investors Michael Booth, DPhil +1 302 498 5914
mbooth@incyte.com
Incyte (NASDAQ:INCY)
Historical Stock Chart
From Jun 2024 to Jul 2024
Incyte (NASDAQ:INCY)
Historical Stock Chart
From Jul 2023 to Jul 2024