Pivotal trial to evaluate epacadostat in combination with Keytruda®
(pembrolizumab) as first-line treatment for patients with advanced or
WILMINGTON, Del.--(BUSINESS WIRE)--Jun. 22, 2016--
Incyte Corporation (Nasdaq: INCY) today announced that the first patient
has been treated in the ECHO-301 study—a Phase 3 trial evaluating
epacadostat, Incyte’s investigational, highly potent and selective oral
IDO1 inhibitor, in combination with Keytruda®
(pembrolizumab), Merck’s anti-PD-1 therapy, as first-line treatment for
patients with advanced or metastatic melanoma. Incyte expects initial
data from the ECHO-301 study to be available in 2018.
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“We are very pleased to treat the first patient in the ECHO-301 study
and advance the Phase 3 program evaluating epacadostat in combination
with pembrolizumab,” said Steven Stein, M.D. Incyte’s Chief Medical
Officer. “This trial—the first to test this combination in a pivotal
study—is part of the larger ECHO program evaluating epacadostat,
including combination studies with anti-PD-1 and PD-L1 therapies across
multiple tumor types.”
Melanoma, the most serious form of skin cancer, strikes adults of all
ages. In the U.S., melanoma accounts for approximately five percent of
all new cases of cancer each year. The incidence of melanoma continues
to rise by almost three percent each year which translates to 76,000 new
cases yearly in the U.S. alone.1 In the European Union, there
are approximately 41,000 new cases of melanoma per year and
approximately 11,000 deaths annually.2
About ECHO-301 (Keynote-252/NCT02752074)
This Phase 3 randomized, double-blind, placebo-controlled study will
evaluate pembrolizumab in combination with epacadostat or placebo in
patients with unresectable or metastatic melanoma. ECHO-301 will enroll
600 patients, randomized 1:1, who will be stratified by PD-L1 expression
(positive versus negative/indeterminate) and BRAF mutation status (BRAF
mutant who have received prior BRAF-directed treatment or BRAF mutant
with no prior BRAF-directed treatment and BRAF wild type).
The two primary endpoints of the study are progression-free survival and
overall survival. Key secondary endpoints include objective response
rate, safety and tolerability.
ECHO-301 is co-sponsored by Incyte and Merck. For more information about
the study, please visit https://clinicaltrials.gov/show/NCT02752074.
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. Ongoing Phase 1 and Phase 2 studies
are investigating epacadostat in combination with PD-1 and PD-L1
inhibitors in a variety of other cancer histologies.
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 with respect to the
design and expected progress of, and release of data from, the ECHO-301
study the efficacy of such trial and the effect such trial may have on
patient outcomes, and the evaluation of epacadostat in other clinical
programs, 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 March 31, 2016. Incyte disclaims any
intent or obligation to update these forward-looking statements.
*The brand listed is not a trademark of Incyte Corporation. The maker of
this brand is not affiliated with and does not endorse Incyte
Corporation or its products.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc.
1 Siegel R, Naishadham MA, Jemal A. Cancer statistics, 2012.
CA Cancer J Clin. Jan- 2012;62:10-29.
2 Ferlay J, Shin
HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide
burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer 2010;127:2893-2917.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160622006234/en/
Source: Incyte Corporation
Catalina Loveman, +1 302 498
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