First Data from Combination of Epacadostat with Opdivo® (nivolumab) Will Be Highlighted at ASCO 2017
18 May 2017 - 7:03AM
Business Wire
Combination is well-tolerated and demonstrates
promising clinical outcomes in multiple advanced solid tumors
Incyte Corporation (Nasdaq:INCY) today announced that the
American Society of Clinical Oncology (ASCO) has published Phase
1/2 data from the ongoing ECHO-204 trial evaluating the safety and
efficacy of epacadostat, Incyte’s selective IDO1 enzyme inhibitor,
in combination with Opdivo® (nivolumab), Bristol-Myers Squibb’s
PD-1 immune checkpoint inhibitor. Efficacy data in patients with
squamous cell carcinoma of the head and neck (SCCHN), melanoma
(MEL), ovarian cancer (OVC), and colorectal cancer (CRC), as well
as overall safety data will be highlighted in an oral presentation
at the American Society of Clinical Oncology (ASCO) annual meeting
in Chicago, Illinois from June 2-6, 2017.
“These first Phase 1/2 data from our ECHO-204 trial evaluating
epacadostat plus nivolumab in multiple solid tumors add to our
knowledge of the therapeutic potential of IDO1 enzyme inhibition
when combined with PD-1 blockade,” said Steven Stein, M.D., Chief
Medical Officer, Incyte. “These results show that the combination
was well-tolerated across patients studied and demonstrates
promising clinical responses, particularly in melanoma and SCCHN.
We look forward to sharing updated data from these cohorts at ASCO
next month, and to progressing our clinical development program for
this combination into pivotal studies.”
ECHO-204 Abstract Highlights
ECHO-204 evaluated the safety and efficacy of the epacadostat
and nivolumab combination in 241 patients (data cut-off as of
October 29, 2016). In 30 patients with MEL treated with nivolumab
plus epacadostat at 100 mg or 300 mg, the combined disease control
rate (DCR; defined as complete response + partial response + stable
disease) was 73 percent (22/30). In patients with SCCHN treated
with nivolumab plus epacadostat 300 mg, the preliminary DCR was 70
percent (16/23). Response rates based on updated data will be
presented at the ASCO Annual Meeting.
In Phase 1 (dose escalation), 36 patients were enrolled and no
dose-limiting toxicities were observed. Among the 205 patients
enrolled in Phase 2, the most frequent treatment-related adverse
events (TRAEs) (≥15 percent) in patients receiving epacadostat 100
mg BID (70/205) and 300 mg BID (135/205) were rash (33 percent and
22 percent, receptively), fatigue (26 percent and 31 percent), and
nausea (24 percent and 19 percent). Rash was the most common ≥3
TRAE (10 percent and 12 percent). TRAEs led to discontinuation in 7
percent (100 mg) and 13 percent (300 mg) of patients. There were no
treatment-related deaths.
This ECHO-204 abstract (#3003) was made available today on the
ASCO website at www.asco.org.
About ECHO-204
The ECHO-204 study (NCT02327078) is a Phase 1/2 study evaluating
the safety and efficacy of epacadostat, Incyte’s selective IDO1
inhibitor, in combination with nivolumab in subjects with select
advanced solid tumors and lymphomas, including melanoma (MEL),
non-small cell lung cancer (NSCLC), colorectal cancer (CRC), head
and neck squamous cell carcinoma (SCCHN), ovarian cancer, and B
cell non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL). Patients
previously treated with anti-PD-1 or anti-CTLA-4 therapies were
excluded from this trial. Enrollment for the Phase 2 (epacadostat
100 or 300 mg BID + nivolumab 240 Q2W) tumor-specific cohorts is
ongoing. For more information about ECHO-204, visit
https://clinicaltrials.gov/ct2/show/NCT02327078.
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.
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-204 study, whether and when epacadostat in
combination with nivolumab will continue to show promising clinical
responses or progress into pivotal trials, 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.
Opdivo is a registered trademark of Bristol-Meyers Squibb.
Bristol-Myers Squibb holds development and commercial rights to
Opdivo globally except for in the Ono Pharmaceutical territories of
Japan, South Korea and Taiwan.
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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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