Incyte’s IDO1 inhibitor in combination with
Merck’s anti-PD-1 therapy is well-tolerated and demonstrates
durable clinical response in patients with treatment-naïve advanced
melanoma
Incyte Corporation (Nasdaq: INCY) today announced that the
European Society for Medical Oncology (ESMO) has published an
abstract (#1110PD) containing updated data from the Phase 1 portion
of the ECHO-202 trial evaluating the safety and efficacy of
epacadostat, Incyte’s selective IDO1 enzyme inhibitor, in
combination with Keytruda® (pembrolizumab), Merck’s anti-PD-1
therapy. These data will be highlighted in a poster discussion on
Monday, 10 October 2016 from 11:00-12:00 CET at the ESMO Annual
Congress 2016 in Copenhagen, Denmark.
In patients with treatment-naïve advanced melanoma (n=19),
updated data show a disease control rate (DCR) of 74 percent and an
overall response rate (ORR) of 58 percent. All responses are
confirmed and ongoing (median follow-up 42 weeks); median
progression-free survival (PFS) has not been reached.
“We are very pleased that after extended treatment and longer
follow-up, these updated Phase 1 data for epacadostat in
combination with pembrolizumab demonstrate robust, durable clinical
activity in patients with treatment-naïve advanced melanoma and
reinforce the promise of IDO1 inhibition in combination with an
anti-PD-1 therapy as an important component of immunotherapy,” said
Steven Stein, M.D., Incyte’s Chief Medical Officer.
Epacadostat in combination with pembrolizumab was
well-tolerated. The most common (≥15%) all grade treatment-related
adverse events (TRAEs) were fatigue, rash, arthralgia, pruritus,
diarrhea and nausea. Grade ≥3 TRAEs were observed in 18% of
patients; the most common were rash (8%) and increased lipase
(3%).
The ECHO-202 abstract was made available today on the ESMO
Congress website at
http://esmo.org/Conferences/ESMO-2016-Congress.
The ECHO-202 poster is expected to be made available to
attendees at the ESMO Congress on Friday, 7 October 2016, at which
time the ECHO-202 poster will be made available via the Events and
Presentations tab of the Investor section of www.incyte.com. Incyte
will also host an investor conference call and webcast at 14:00 CET
(8:00 a.m. ET) on 7 October 2016 which can be accessed via the
Events and Presentations tab of the Investor section of
www.incyte.com.
About ECHO-202 (KEYNOTE-037)
The ECHO-202 study (NCT02178722) is evaluating the safety and
efficacy of epacadostat, Incyte’s selective IDO1 inhibitor, in
combination with pembrolizumab. Patients previously treated with
anti-PD-1 or anti-CTLA-4 therapies were excluded from this trial.
Enrollment is complete for the Phase 1 dose escalation (epacadostat
25, 50, 100 mg BID + pembrolizumab 2 mg/kg IV Q3W and epacadostat
300 mg BID + pembrolizumab 200 mg IV Q3W) and Phase 1 dose
expansion (epacadostat 50, 100, and 300 mg BID + pembrolizumab 200
mg IV Q3W) portions of the trial. Enrollment in the Phase 2
tumor-specific cohorts is ongoing.
About ECHO
The ECHO clinical trial program was established to investigate
the efficacy and safety of epacadostat as a core component of
combination therapy in oncology. Ongoing Phase 1 and Phase 2
studies evaluating epacadostat in combination with PD-1 and PD-L1
inhibitors collectively plan to enroll over 900 patients in a broad
range of solid tumor types, as well as hematological malignancies.
ECHO-301 (NCT02752074), a Phase 3 randomized, double-blind,
placebo-controlled study evaluating pembrolizumab in combination
with epacadostat or placebo as first-line treatment for patients
with advanced or metastatic melanoma, is also underway. ECHO-301
was initiated in June 2016 and initial data from this study are
expected to be available in 2018.
About Epacadostat (INCB024360)
Indoleamine 2,3-dioxygenase 1 (IDO1) is a key immunosuppressive
enzyme that modulates the anti-tumor immune response by promoting
regulatory T cell generation and blocking effector T cell
activation, thereby facilitating tumor growth by allowing cancer
cells to avoid immune surveillance. Epacadostat is a
first-in-class, highly potent and selective oral inhibitor of the
IDO1 enzyme that reverses tumor-associated immune suppression and
restores effective anti-tumor immune responses. In single-arm
studies, the combination of epacadostat and immune checkpoint
inhibitors has shown proof-of-concept in patients with unresectable
or metastatic melanoma. In these studies, epacadostat combined with
the CTLA-4 inhibitor ipilimumab or the PD-1 inhibitor pembrolizumab
improved response rates compared with studies of the immune
checkpoint inhibitors alone.
Conference Call Information
To access the conference call, please dial 877-407-9221 for
domestic callers or +1-201-689-8597 for international callers. When
prompted, provide the conference identification number,
13644034.
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 +1-201-612-7415. To access the replay you
will need the conference identification number, 13644034.
About Incyte
Incyte Corporation is a Wilmington, Delaware-based
biopharmaceutical company focused on the discovery, development and
commercialization of proprietary therapeutics. For additional
information on Incyte, please visit the Company’s website at
www.incyte.com.
Follow @Incyte on Twitter at https://twitter.com/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 and discussion of data regarding the
Company’s ECHO-202 study and the expected timetable for
availability of initial data from its ECHO-301 study, 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 and the risks related to the efficacy or safety of the
Company’s development pipeline, the results of further research and
development, the high degree of risk and uncertainty associated
with drug development, clinical trials and regulatory approval
processes, other market or economic factors and competitive and
technological advances; 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 June,
2016. Incyte disclaims any intent or obligation to update these
forward-looking statements.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160928005593/en/
Incyte CorporationMediaCatalina Loveman, +1
302-498-6171cloveman@incyte.comorInvestorsMichael Booth,
DPhil, +1 302-498-5914mbooth@incyte.com
Incyte (NASDAQ:INCY)
Historical Stock Chart
From Apr 2024 to May 2024
Incyte (NASDAQ:INCY)
Historical Stock Chart
From May 2023 to May 2024