Responses observed with combination of IDO1
enzyme inhibition and anti-PD-1 therapy support advancing into
broad Phase 3 program
Safety data for this novel investigational
immunotherapy combination are generally similar to KEYTRUDA
monotherapy
Incyte Corporation (Nasdaq:INCY) and Merck (NYSE:MRK), known as
MSD outside the United States and Canada, today announced that
updated data from the ongoing Phase 1/2 ECHO-202 trial evaluating
epacadostat, Incyte’s selective IDO1 enzyme inhibitor, in
combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1
therapy, will be highlighted in multiple presentations at the 2017
American Society of Clinical Oncology (ASCO) Annual Meeting in
Chicago. Updated efficacy data at ASCO are from multiple tumor
cohorts – metastatic or recurrent squamous cell carcinoma of the
head and neck (SCCHN), advanced urothelial bladder cancer (UC) and
advanced renal cell carcinoma (RCC) – as well as a pooled safety
analysis (Phase 2) of the total study population (across all tumor
cohorts). Data will be highlighted in two oral presentations (SCCHN
and UC) and two poster discussions (RCC and pooled safety).
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“We are pleased to report additional data from multiple
tumor-specific cohorts of our Phase 1/2 ECHO-202 trial, which
continue to provide encouraging efficacy and safety data for this
investigational treatment combination,” said Steven Stein, M.D.,
Chief Medical Officer, Incyte. “These and other data presented here
in Chicago underscore the potential of this novel investigational
immunotherapy combination in multiple advanced cancers, supporting
the advancement of our clinical development program for epacadostat
and KEYTRUDA into multiple Phase 3 clinical trials.”
Efficacy Data from ECHO-202 (Abstract #6010, #4503,
#4515)
Results of these tumor cohorts (as of February 27, 2017)
include:
SCCHN
(Abstract #6010)
UC
(Abstract #4503)
RCC
(Abstract #4515)
Total Subgroup
N (%)
Prior Lines of Treatment
N (%)
Total Subgroup
N (%)
Prior Lines of Treatment
N (%)
Total Subgroup
N (%)
Prior Lines of Treatment
N (%)
Total 1-2
>3
Total 0-1 ≥2 Total 0-1 ≥2 ORR 13/38(34)
3 CR
10 PR
12/31(39)3 CR
9 PR
1/7(14)1 PR 14/40(35)3 CR11 PR 12/32
(38)3 CR9 PR
2/8(25)2 PR 10/30(33)1 CR9 PR 9/19(47)1 CR8 PR 1/11(9)1 PR DCR
23/38(61)
20/31
(65)
3/7(43)
21/40(53)
19/32
(59)
2/8(25)
15/30(50)
11/19(58)
4/11(36)
DoR 10/13 responses ongoing
Median range: 18.4+ (7.1 to 90.3+)
weeks
10/14 responses ongoing
Median range: 30.6+ (9.7 to 93.1+)
weeks
7/10 responses ongoingMedian range: 26.8+ (18.1+ to 53.1) weeks
Objective Response Rate (ORR), Disease Control Rate (DCR),
Duration of Response (DoR), Complete Response (CR), Partial
Response (PR)
Safety Data from ECHO-202 (Abstract #3012)
In addition to the efficacy data above, an updated pooled
analysis evaluated 294 patients with advanced cancers in the
ECHO-202 Phase 2 safety population. Treatment-related adverse
events (TRAEs) occurred in 67 percent (n=197/294) of patients. The
most common TRAEs included fatigue (29%), rash (17%), nausea (11%)
and pruritus (10%). Grade ≥3 TRAEs occurred in 18 percent
(n=52/294) of patients, the most common of which were increased
lipase (asymptomatic) (4%) and rash (3%). TRAEs led to
discontinuation of treatment in four percent of study patients. The
safety profile of epacadostat plus KEYTRUDA (pembrolizumab) was
generally consistent with previously reported ECHO-202 Phase 1 data
and with the safety profile of KEYTRUDA monotherapy.
“The combination of KEYTRUDA and epacadostat as a treatment for
multiple advanced solid tumors has shown promise in our preliminary
Phase 1/2 clinical trials,” said Dr. Roger Dansey, senior vice
president and therapeutic area head, oncology late-stage
development, Merck Research Laboratories. “We welcome the
opportunity to collaborate with Incyte and we look forward to
progressing this combination in pivotal trials.”
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 Merck’s KEYTRUDA. 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 + KEYTRUDA 2 mg/kg IV Q3W and epacadostat 300 mg
BID + KEYTRUDA 200 mg IV Q3W) and Phase 1 dose expansion
(epacadostat 50, 100, and 300 mg BID + KEYTRUDA [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 an
investigational, 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
KEYTRUDA improved response rates compared with studies of the
immune checkpoint inhibitors alone.
About KEYTRUDA® (pembrolizumab)
Injection
KEYTRUDA is an anti-PD-1 therapy that works by increasing the
ability of the body’s immune system to help detect and fight tumor
cells. KEYTRUDA is a humanized monoclonal antibody that blocks the
interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby
activating T lymphocytes which may affect both tumor cells and
healthy cells.
Studies of KEYTRUDA – from the largest immuno-oncology program
in the industry with more than 500 trials – include a wide variety
of cancers and treatment settings. The KEYTRUDA clinical program
seeks to understand factors that predict a patient’s likelihood of
benefitting from treatment with KEYTRUDA, including the exploration
of several different biomarkers across a broad range of tumors.
KEYTRUDA is administered as an intravenous infusion over 30
minutes every three weeks for the approved indications. KEYTRUDA
for injection is supplied in a 100 mg single-dose vial.
KEYTRUDA (pembrolizumab) Indications and
Dosing
Melanoma
KEYTRUDA is indicated for the treatment of patients with
unresectable or metastatic melanoma at a fixed dose of 200 mg every
three weeks until disease progression or unacceptable toxicity.
Lung Cancer
KEYTRUDA, as a single agent, is indicated for the first-line
treatment of patients with metastatic non-small cell lung cancer
(NSCLC) whose tumors have high PD-L1 expression [tumor proportion
score (TPS) ≥50%] as determined by an FDA-approved test, with no
EGFR or ALK genomic tumor aberrations.
KEYTRUDA, as a single agent, is also indicated for the treatment
of patients with metastatic NSCLC whose tumors express PD-L1 (TPS
≥1%) as determined by an FDA-approved test, with disease
progression on or after platinum-containing chemotherapy. Patients
with EGFR or ALK genomic tumor aberrations should have disease
progression on FDA-approved therapy for these aberrations prior to
receiving KEYTRUDA.
KEYTRUDA, in combination with pemetrexed and carboplatin, is
indicated for the first-line treatment of patients with metastatic
nonsquamous NSCLC. This indication is approved under accelerated
approval based on tumor response rate and progression-free
survival. Continued approval for this indication may be contingent
upon verification and description of clinical benefit in the
confirmatory trials.
In metastatic NSCLC, KEYTRUDA is administered at a fixed dose of
200 mg every three weeks until disease progression, unacceptable
toxicity, or up to 24 months in patients without disease
progression.
When administering KEYTRUDA in combination with chemotherapy,
KEYTRUDA should be administered prior to chemotherapy when given on
the same day. See also the Prescribing Information for pemetrexed
and carboplatin.
Head and Neck Cancer
KEYTRUDA is indicated for the treatment of patients with
recurrent or metastatic head and neck squamous cell carcinoma
(HNSCC) with disease progression on or after platinum-containing
chemotherapy. This indication is approved under accelerated
approval based on tumor response rate and durability of response.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in the
confirmatory trials. In HNSCC, KEYTRUDA is administered at a fixed
dose of 200 mg every three weeks until disease progression,
unacceptable toxicity, or up to 24 months in patients without
disease progression.
Classical Hodgkin Lymphoma
KEYTRUDA (pembrolizumab) is indicated for the treatment of adult
and pediatric patients with refractory classical Hodgkin lymphoma
(cHL), or who have relapsed after three or more prior lines of
therapy. This indication is approved under accelerated approval
based on tumor response rate and durability of response. Continued
approval for this indication may be contingent upon verification
and description of clinical benefit in the confirmatory trials. In
adults with cHL, KEYTRUDA is administered at a fixed dose of 200 mg
every three weeks until disease progression or unacceptable
toxicity, or up to 24 months in patients without disease
progression. In pediatric patients with cHL, KEYTRUDA is
administered at a dose of 2 mg/kg (up to a maximum of 200 mg) every
three weeks until disease progression or unacceptable toxicity, or
up to 24 months in patients without disease progression.
Urothelial Carcinoma
KEYTRUDA is indicated for the treatment of patients with locally
advanced or metastatic urothelial carcinoma who are not eligible
for cisplatin-containing chemotherapy. This indication is approved
under accelerated approval based on tumor response rate and
duration of response. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
the confirmatory trials.
KEYTRUDA is also indicated for the treatment of patients with
locally advanced or metastatic urothelial carcinoma who have
disease progression during or following platinum-containing
chemotherapy or within 12 months of neoadjuvant or adjuvant
treatment with platinum-containing chemotherapy.
In locally advanced or metastatic urothelial carcinoma, KEYTRUDA
is administered at a fixed dose of 200 mg every three weeks until
disease progression or unacceptable toxicity, or up to 24 months in
patients without disease progression.
Microsatellite Instability-High (MSI-H) Cancer
KEYTRUDA is indicated for the treatment of adult and pediatric
patients with unresectable or metastatic microsatellite
instability-high (MSI-H) or mismatch repair deficient (dMMR)
- solid tumors that have progressed
following prior treatment and who have no satisfactory alternative
treatment options, or
- colorectal cancer that has progressed
following treatment with fluoropyrimidine, oxaliplatin, and
irinotecan.
This indication is approved under accelerated approval based on
tumor response rate and durability of response. Continued approval
for this indication may be contingent upon verification and
description of clinical benefit in the confirmatory trials. The
safety and effectiveness of KEYTRUDA in pediatric patients with
MSI-H central nervous system cancers have not been established.
In adult patients with MSI-H cancer, KEYTRUDA (pembrolizumab) is
administered at a fixed dose of 200 mg every three weeks until
disease progression, unacceptable toxicity, or up to 24 months in
patients without disease progression. In pediatric patients with
MSI-H cancer, KEYTRUDA is administered at a dose of 2 mg/kg (up to
a maximum of 200 mg) every three weeks until disease progression or
unacceptable toxicity, or up to 24 months in patients without
disease progression.
Selected Important Safety Information for
KEYTRUDA® (pembrolizumab)
KEYTRUDA can cause immune-mediated pneumonitis, including fatal
cases. Pneumonitis occurred in 94 (3.4%) of 2799 patients receiving
KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%),
and 5 (0.1%) pneumonitis, and occurred more frequently in patients
with a history of prior thoracic radiation (6.9%) compared to those
without (2.9%). Monitor patients for signs and symptoms of
pneumonitis. Evaluate suspected pneumonitis with radiographic
imaging. Administer corticosteroids for Grade 2 or greater
pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue
KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.
KEYTRUDA can cause immune-mediated colitis. Colitis occurred in
48 (1.7%) of 2799 patients receiving KEYTRUDA, including Grade 2
(0.4%), 3 (1.1%), and 4 (<0.1%) colitis. Monitor patients for
signs and symptoms of colitis. Administer corticosteroids for Grade
2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3;
permanently discontinue KEYTRUDA for Grade 4 colitis.
KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred
in 19 (0.7%) of 2799 patients receiving KEYTRUDA, including Grade 2
(0.1%), 3 (0.4%), and 4 (<0.1%) hepatitis. Monitor patients for
changes in liver function. Administer corticosteroids for Grade 2
or greater hepatitis and, based on severity of liver enzyme
elevations, withhold or discontinue KEYTRUDA.
KEYTRUDA can cause hypophysitis. Hypophysitis occurred in 17
(0.6%) of 2799 patients receiving KEYTRUDA, including Grade 2
(0.2%), 3 (0.3%), and 4 (<0.1%) hypophysitis. Monitor patients
for signs and symptoms of hypophysitis (including hypopituitarism
and adrenal insufficiency). Administer corticosteroids and hormone
replacement as clinically indicated. Withhold KEYTRUDA for Grade 2;
withhold or discontinue for Grade 3 or 4 hypophysitis.
KEYTRUDA can cause thyroid disorders, including hyperthyroidism,
hypothyroidism, and thyroiditis. Hyperthyroidism occurred in 96
(3.4%) of 2799 patients receiving KEYTRUDA, including Grade 2
(0.8%) and 3 (0.1%) hyperthyroidism. Hypothyroidism occurred in 237
(8.5%) of 2799 patients receiving KEYTRUDA, including Grade 2
(6.2%) and 3 (0.1%) hypothyroidism. The incidence of new or
worsening hypothyroidism was higher in patients with HNSCC,
occurring in 28 (15%) of 192 patients with HNSCC, including Grade 3
(0.5%) hypothyroidism. Thyroiditis occurred in 16 (0.6%) of 2799
patients receiving KEYTRUDA, including Grade 2 (0.3%) thyroiditis.
Monitor patients for changes in thyroid function (at the start of
treatment, periodically during treatment, and as indicated based on
clinical evaluation) and for clinical signs and symptoms of thyroid
disorders. Administer replacement hormones for hypothyroidism and
manage hyperthyroidism with thionamides and beta-blockers as
appropriate. Withhold or discontinue KEYTRUDA (pembrolizumab) for
Grade 3 or 4 hyperthyroidism.
KEYTRUDA can cause type 1 diabetes mellitus, including diabetic
ketoacidosis, which have been reported in 6 (0.2%) of 2799
patients. Monitor patients for hyperglycemia or other signs and
symptoms of diabetes. Administer insulin for type 1 diabetes, and
withhold KEYTRUDA and administer antihyperglycemics in patients
with severe hyperglycemia.
KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred
in 9 (0.3%) of 2799 patients receiving KEYTRUDA, including Grade 2
(0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Monitor patients for
changes in renal function. Administer corticosteroids for Grade 2
or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently
discontinue KEYTRUDA for Grade 3 or 4 nephritis.
KEYTRUDA can cause other clinically important immune-mediated
adverse reactions. These immune-mediated reactions may occur in any
organ system. For suspected immune-mediated adverse reactions,
ensure adequate evaluation to confirm etiology or exclude other
causes. Based on the severity of the adverse reaction, withhold
KEYTRUDA and administer corticosteroids. Upon improvement to Grade
1 or less, initiate corticosteroid taper and continue to taper over
at least 1 month. Based on limited data from clinical studies in
patients whose immune-related adverse reactions could not be
controlled with corticosteroid use, administration of other
systemic immunosuppressants can be considered. Resume KEYTRUDA when
the adverse reaction remains at Grade 1 or less following
corticosteroid taper. Permanently discontinue KEYTRUDA for any
Grade 3 immune-mediated adverse reaction that recurs and for any
life-threatening immune-mediated adverse reaction.
The following clinically significant immune-mediated adverse
reactions occurred in less than 1% (unless otherwise indicated) of
2799 patients: arthritis (1.5%), exfoliative dermatitis, bullous
pemphigoid, rash (1.4%), uveitis, myositis, Guillain-Barré
syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic
anemia, and partial seizures arising in a patient with inflammatory
foci in brain parenchyma. In addition, myelitis and myocarditis
were reported in other clinical trials, including classical Hodgkin
lymphoma, and postmarketing use.
Solid organ transplant rejection has been reported in
postmarketing use of KEYTRUDA. Treatment with KEYTRUDA may increase
the risk of rejection in solid organ transplant recipients.
Consider the benefit of treatment with KEYTRUDA vs the risk of
possible organ rejection in these patients.
KEYTRUDA can cause severe or life-threatening infusion-related
reactions, including hypersensitivity and anaphylaxis, which have
been reported in 6 (0.2%) of 2799 patients. Monitor patients for
signs and symptoms of infusion-related reactions, including rigors,
chills, wheezing, pruritus, flushing, rash, hypotension, hypoxemia,
and fever. For Grade 3 or 4 reactions, stop infusion and
permanently discontinue KEYTRUDA (pembrolizumab).
Immune-mediated complications, including fatal events, occurred
in patients who underwent allogeneic hematopoietic stem cell
transplantation (HSCT) after being treated with KEYTRUDA. Of 23
patients with cHL who proceeded to allogeneic HSCT after treatment
with KEYTRUDA on any trial, 6 patients (26%) developed
graft-versus-host-disease (GVHD), one of which was fatal, and 2
patients (9%) developed severe hepatic veno-occlusive disease (VOD)
after reduced-intensity conditioning, one of which was fatal. Cases
of fatal hyperacute GVHD after allogeneic HSCT have also been
reported in patients with lymphoma who received a PD-1
receptor–blocking antibody before transplantation. These
complications may occur despite intervening therapy between PD-1
blockade and allogeneic HSCT. Follow patients closely for early
evidence of transplant-related complications such as hyperacute
GVHD, severe (Grade 3 to 4) acute GVHD, steroid-requiring febrile
syndrome, hepatic VOD, and other immune-mediated adverse reactions,
and intervene promptly.
Based on its mechanism of action, KEYTRUDA can cause fetal harm
when administered to a pregnant woman. If used during pregnancy, or
if the patient becomes pregnant during treatment, apprise the
patient of the potential hazard to a fetus. Advise females of
reproductive potential to use highly effective contraception during
treatment and for 4 months after the last dose of KEYTRUDA.
KEYTRUDA was discontinued due to adverse reactions in 17% of 192
patients with HNSCC. Serious adverse reactions occurred in 45% of
patients. The most frequent serious adverse reactions reported in
at least 2% of patients were pneumonia, dyspnea, confusional state,
vomiting, pleural effusion, and respiratory failure. The most
common adverse reactions (reported in at least 20% of patients)
were fatigue, decreased appetite, and dyspnea. Adverse reactions
occurring in patients with HNSCC were generally similar to those
occurring in patients with melanoma or NSCLC, with the exception of
increased incidences of facial edema (10% all Grades; 2.1% Grades 3
or 4) and new or worsening hypothyroidism.
In KEYNOTE-052, KEYTRUDA was discontinued due to adverse
reactions in 11% of 370 patients with locally advanced or
metastatic urothelial carcinoma. The most common adverse reactions
(in ≥20% of patients) were fatigue (38%), musculoskeletal pain
(24%), decreased appetite (22%), constipation (21%), rash (21%),
and diarrhea (20%). Eighteen patients (5%) died from causes other
than disease progression. Five patients (1.4%) who were treated
with KEYTRUDA experienced sepsis which led to death, and 3 patients
(0.8%) experienced pneumonia which led to death. Adverse reactions
leading to interruption of KEYTRUDA occurred in 22% of patients;
the most common (≥1%) were liver enzyme increase, diarrhea, urinary
tract infection, acute kidney injury, fatigue, joint pain, and
pneumonia. Serious adverse reactions occurred in 42% of patients,
the most frequent (≥2%) of which were urinary tract infection,
hematuria, acute kidney injury, pneumonia, and urosepsis.
In KEYNOTE-045, KEYTRUDA (pembrolizumab) was discontinued due to
adverse reactions in 8% of 266 patients with locally advanced or
metastatic urothelial carcinoma. The most common adverse reaction
resulting in permanent discontinuation of KEYTRUDA was pneumonitis
(1.9%). Adverse reactions leading to interruption of KEYTRUDA
occurred in 20% of patients; the most common (≥1%) were urinary
tract infection (1.5%), diarrhea (1.5%), and colitis (1.1%). The
most common adverse reactions (≥20%) in patients who received
KEYTRUDA vs those who received chemotherapy were fatigue (38% vs
56%), musculoskeletal pain (32% vs 27%), pruritus (23% vs 6%),
decreased appetite (21% vs 21%), nausea (21% vs 29%), and rash (20%
vs 13%). Serious adverse reactions occurred in 39% of
KEYTRUDA-treated patients, the most frequent (≥2%) of which were
urinary tract infection, pneumonia, anemia, and pneumonitis.
It is not known whether KEYTRUDA is excreted in human milk.
Because many drugs are excreted in human milk, instruct women to
discontinue nursing during treatment with KEYTRUDA and for 4 months
after the final dose.
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.
Merck’s Focus on Cancer
Merck’s goal is to translate breakthrough science into
innovative oncology medicines to help people with cancer worldwide.
At Merck, helping people fight cancer is our passion and supporting
accessibility to our cancer medicines is our commitment. Our focus
is on pursuing research in immuno-oncology and we are accelerating
every step in the journey – from lab to clinic – to potentially
bring new hope to people with cancer.
As part of our focus on cancer, Merck is committed to exploring
the potential of immuno-oncology with one of the fastest-growing
development programs in the industry. We are currently executing an
expansive research program that includes more than 500 clinical
trials evaluating our anti-PD-1 therapy across more than 30 tumor
types. We also continue to strengthen our immuno-oncology portfolio
through strategic acquisitions and are prioritizing the development
of several promising immunotherapeutic candidates with the
potential to improve the treatment of advanced cancers.
For more information about our oncology clinical trials, visit
www.merck.com/clinicaltrials.
About Merck
For more than a century, Merck, a leading global
biopharmaceutical company known as MSD outside of the United States
and Canada, has been inventing for life, bringing forward medicines
and vaccines for many of the world’s most challenging diseases.
Through our prescription medicines, vaccines, biologic therapies
and animal health products, we work with customers and operate in
more than 140 countries to deliver innovative health solutions. We
also demonstrate our commitment to increasing access to health care
through far-reaching policies, programs and partnerships. Today,
Merck continues to be at the forefront of research to advance the
prevention and treatment of diseases that threaten people and
communities around the world - including cancer, cardio-metabolic
diseases, emerging animal diseases, Alzheimer’s disease and
infectious diseases including HIV and Ebola. For more information,
visit www.merck.com and connect with us
on Twitter, Facebook, Instagram, YouTube
and LinkedIn.
Forward-Looking Statement of Incyte Corporation
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.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and uncertainties.
There can be no guarantees with respect to pipeline products that
the products will receive the necessary regulatory approvals or
that they will prove to be commercially successful. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; global trends
toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; the company’s ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of the company’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s 2016
Annual Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
Please see Prescribing Information for KEYTRUDA
(pembrolizumab)
at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf and
Patient Information/Medication Guide for KEYTRUDA
at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf.
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Incyte CorporationMediaCatalina Loveman, +1
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