Updated data published at ESMO to be discussed
on Incyte investor conference call and webcast today, 7 October, at
14:00 CET / 8:00 a.m. ET
Incyte Corporation (Nasdaq:INCY) today announced that updated
data from the Phase I portion of the ECHO-202 trial evaluating the
safety and efficacy of epacadostat, Incyte’s selective IDO1 enzyme
inhibitor, in combination with pembrolizumab (Keytruda®)*, Merck’s
anti-PD-1 therapy, have been published as a poster at the European
Society for Medical Oncology (ESMO) Annual Congress 2016 in
Copenhagen, Denmark.
Further to the previously published abstract, today’s updated
data show that among patients with treatment-naïve advanced
melanoma (n=19), the combination of epacadostat plus pembrolizumab
resulted in progression-free survival (PFS) rates of 74 percent and
57 percent at 6 months and 12 months, respectively. Median PFS has
not been reached. The updated data also show an increase in the
complete response (CR) rate to 26 percent. The objective response
rate (ORR) and disease control rate (DCR) remained consistent with
the previously published abstract data, at 58 percent and 74
percent, respectively. All responses are confirmed and ongoing
(median follow-up among responders 56 plus [range of 46 to 90 plus]
weeks).
“We are excited to share further data with additional follow-up
from the Phase 1 portion of the ECHO-202 study,” said Steven Stein,
M.D., Incyte’s Chief Medical Officer. “The durable responses seen
in patients with treatment-naïve advanced or metastatic melanoma
reaffirm the activity of this immunotherapy combination, and we
look forward to the read-out of ECHO-301, the ongoing, pivotal
Phase 3 trial.”
Epacadostat in combination with pembrolizumab was well tolerated
in the Phase 1 population (n=62). The most common (≥15%) all grade
treatment-related AEs (TRAEs) were fatigue, rash, pruritus,
arthralgia, diarrhea and nausea. Grade ≥3 TRAEs were observed in 19
percent of patients; the most common were rash (8%) and increased
lipase (5%). Five patients (8%) discontinued treatment due to
TRAEs.
The ECHO-202 poster was made available to attendees at the ESMO
Congress today, Friday, 7 October, and will be made available via
the Events and Presentations tab of the Investor section of
www.incyte.com. Incyte will host an investor conference call and
webcast at 14:00 CET (8:00 a.m. ET) today, 7 October 2016, which
can also 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 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 for the first-line treatment of
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 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/20161007005217/en/
MediaCatalina Loveman,
302-498-6171cloveman@incyte.comorInvestorsMichael Booth,
DPhil, 302-498-5914mbooth@incyte.com
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