Incyte’s IDO1 enzyme inhibitor in combination
with Merck’s anti-PD-1 therapy is well-tolerated and demonstrates
durable clinical responses across multiple solid tumors
Incyte Corporation (Nasdaq:INCY) today announced the publication
of new data from the ongoing ECHO-202 trial, evaluating
epacadostat, Incyte’s selective IDO1 enzyme inhibitor, in
combination with Keytruda® (pembrolizumab), Merck’s anti-PD-1
therapy. Abstracts published online by the American Society of
Clinical Oncology (ASCO) in advance of its annual meeting in
Chicago, Illinois, June 2-6, 2017 include ECHO-202 Phase 1/2
efficacy and safety data from the following cohorts: non-small cell
lung cancer (NSCLC), renal cell carcinoma (RCC), bladder cancer,
squamous cell carcinoma of the head and neck (SCCHN),
triple-negative breast cancer (TNBC), and ovarian cancer (OVC).
Pooled Phase 2 safety data across cohorts were also released
today.
“We are very pleased to share these new data for epacadostat in
combination with pembrolizumab. The combination is well-tolerated
and preliminary efficacy outcomes for these cohorts demonstrate
encouraging clinical activity, both within and across tumor types,
which compares favorably to contemporary data in the second-line
setting. These data, including updated data which will be presented
at ASCO next month, supported the recently-announced progression of
the epacadostat and pembrolizumab combination into pivotal trials
in NSCLC, RCC, bladder cancer and SCCHN,” said Steven Stein, M.D.,
Chief Medical Officer, Incyte.
ECHO-202 abstract data for the tumor types entering Phase 3
(data cut as of October 29, 2016) include:
n/N (%)
NSCLC UC
SCCHN RCC All
pts
0-2 prior lines oftherapy for
advanceddisease
All pts
Prior Lines ofTreatment
All pts
Prior Lines ofTreatment
All pts
Prior Lines ofTreatment
Total TPS ≥50%
TPS <50%
Total 0-1
Total 1-2
≥3 Total
0-1 ≥2 ORR 14/40(35)
3/7(43) 6/17(35)
13/37(35) 10/27(37)
11/36(31)
10/29(34)
1/7(14)
9/30(30)
9/19(47)
0/11(0) all PR
all PR all PR all
PR all PR 2 CR,9 PR
2 CR,8 PR 1 PR
1 CR,8 PR 1 CR,8 PR
-
DCR 24/40(60) 4/7(57) 9/17(53) 21/37(57)
17/27(63) 21/36(58)
18/29(62)
3/7(43) 15/30(50) 11/19(58) 4/11(36)
DoR
12/14 responses ongoingrange 1+ - 519
days
12/13 responses ongoingrange 1+ - 652+
days
9/11 responses ongoingrange 1+ - 563+
days
9/9 responses ongoingrange 1+ - 372+
days
In a pooled analysis evaluating 244 patients in the ECHO-202
Phase 2 safety population (abstract #3012), treatment-related
adverse events (TRAEs) that occurred in ≥5 percent of patients,
included fatigue (23 percent); rash (16 percent); diarrhea and
nausea (7 percent each); increased alanine aminotransferase,
increased aspartate aminotransferase, and pruritus (6 percent
each); and pyrexia (5 percent). A total of 37 patients (15 percent)
experienced Grade ≥3 TRAEs; the most common of which were increased
lipase (asymptomatic) and rash (3 percent each). TRAEs led to
discontinuation of treatment in 3 percent of study patients.
These abstracts, including data for TNBC and OVC (abstract
#1103), were made available today on the ASCO website at
www.asco.org.
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. For more information about
ECHO-202, visit
https://clinicaltrials.gov/ct2/show/NCT02178722.
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 investigating KEYTRUDA in combination with
epacadostat or placebo for the treatment of patients with
unresectable or metastatic melanoma, is also underway. For more
information about the ECHO clinical trial program, visit
www.ECHOClinicalTrials.com.
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 regulates the tumor immune microenvironment,
thereby restoring 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.
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 planned pivotal trials of
epacadostat in combination with pembrolizumab, 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,
2017. 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. KEYTRUDA is marketed
by Merck (known as MSD outside the United States and Canada).
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Incyte CorporationMediaCatalina Loveman, +1
302-498-6171cloveman@incyte.comorInvestorsMichael Booth,
DPhil, +1 302-498-5914mbooth@incyte.com
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