Collaboration Builds on Merck’s R&D and
NanoString’s Biomarker Development Leadership Positions in
Immuno-Oncology
Early Data Evaluating Immune-Related
Signatures with KEYTRUDA in Multiple Cancers to be Presented for
the First Time at 2015 ASCO Annual Meeting
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, and NanoString Technologies, Inc. (NASDAQ:NSTG) today
announced a clinical research collaboration to develop an assay
that will optimize immune-related gene expression signatures and
evaluate the potential to predict benefit from Merck’s anti-PD-1
therapy, KEYTRUDA® (pembrolizumab), in multiple tumor types. The
collaboration between NanoString Technologies, Inc., a provider of
life science tools for translational research and molecular
diagnostic products, and Merck, through a subsidiary, will utilize
NanoString’s nCounter® Analysis System to optimize gene expression
signatures as part of the clinical development program for
KEYTRUDA.
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“Our commitment to advancing the science of immuno-oncology
includes pursuing cutting-edge RNA and DNA approaches to identify a
range of biomarkers, such as immune-related gene expression
signatures, that in addition to PD-L1 expression, may help to
identify patients who may be more likely to experience improved
benefit with KEYTRUDA,” said Dr. Eric Rubin, vice president and
therapeutic area head, oncology early-stage development, Merck
Research Laboratories. “Our collaboration with NanoString
Technologies is an important advancement for our early-stage,
immuno-oncology development program. Early data exploring the
predictive value of the NanoString-derived gene expression
signatures with KEYTRUDA will be presented at ASCO 2015.”
“We are excited to work with Merck to help direct treatment with
KEYTRUDA,” said Brad Gray, president and chief executive officer of
NanoString Technologies. “New approaches in immuno-oncology, like
KEYTRUDA, have the potential to transform cancer care across many
different tumor types. With our nCounter technology and in vitro
diagnostic capability, NanoString is ideally positioned to address
the critical challenge of matching patients to powerful new
therapies. This collaboration with Merck complements our existing
relationships with MD Anderson and the Cancer Immunotherapy Trials
Network, and builds on our leadership position in immuno-oncology
biomarker development.”
Early Data on Immune-based Gene Expression Signatures at 2015
ASCO Annual Meeting
First-time presentations of data evaluating immune-based gene
expression signatures developed using NanoString’s nCounter®
Analysis System, and their correlation to patient benefit with
KEYTRUDA will be presented at this year’s 51st Annual Meeting of
the American Society of Clinical Oncology (May 29-June 2, 2015 in
Chicago). The early data to be presented include findings in
bladder cancer (Abstract #4502), advanced melanoma (Abstract
#3001), gastric cancer (Abstract #3026), and head and neck cancer
(Abstract #6017). These early data are based on an initial
signature, the interferon-gamma response gene, which was derived
from initial findings that expression of this immune response gene
predicted response to KEYTRUDA in advanced melanoma patients.
Additional signatures are in development based on extension of
these initial findings.
About KEYTRUDA® (pembrolizumab)
KEYTRUDA (pembrolizumab) is a humanized monoclonal antibody that
blocks the interaction between PD-1 and its ligands, PD-L1 and
PD-L2. By binding to the PD-1 receptor and blocking the interaction
with the receptor ligands, KEYTRUDA releases the PD-1
pathway-mediated inhibition of the immune response, including the
anti-tumor immune response.
KEYTRUDA is indicated in the United States at a dose of 2 mg/kg
administered as an intravenous infusion over 30 minutes every three
weeks for the treatment of patients with unresectable or metastatic
melanoma and disease progression following ipilimumab and, if BRAF
V600 mutation positive, a BRAF inhibitor. This indication is
approved under accelerated approval based on tumor response rate
and durability of response. An improvement in survival or
disease-related symptoms has not yet been established. Continued
approval for this indication may be contingent upon verification
and description of clinical benefit in the confirmatory trials.
Merck is advancing a broad and fast-growing clinical development
program for KEYTRUDA with more than 100 clinical trials – across
more than 30 tumor types and enrolling more than 16,000 patients –
both as a monotherapy and in combination with other therapies.
Selected Important Safety Information for KEYTRUDA
Pneumonitis occurred in 12 (2.9%) of 411 patients with advanced
melanoma receiving KEYTRUDA (the approved indication in the United
States), including Grade 2 or 3 cases in 8 (1.9%) and 1 (0.2%)
patients, respectively. 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 pneumonitis.
Colitis (including microscopic colitis) occurred in 4 (1%) of
411 patients, including Grade 2 or 3 cases in 1 (0.2%) and 2 (0.5%)
patients respectively, receiving KEYTRUDA. 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.
Hepatitis (including autoimmune hepatitis) occurred in 2 (0.5%)
of 411 patients, including a Grade 4 case in 1 (0.2%) patient,
receiving KEYTRUDA. 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.
Hypophysitis occurred in 2 (0.5%) of 411 patients, including a
Grade 2 case in 1 and a Grade 4 case in 1 (0.2% each) patient,
receiving KEYTRUDA. Monitor for signs and symptoms of hypophysitis.
Administer corticosteroids for Grade 2 or greater hypophysitis.
Withhold KEYTRUDA for Grade 2; withhold or discontinue for Grade 3;
and permanently discontinue KEYTRUDA for Grade 4 hypophysitis.
Nephritis occurred in 3 (0.7%) patients receiving KEYTRUDA,
consisting of one case of Grade 2 autoimmune nephritis (0.2%) and
two cases of interstitial nephritis with renal failure (0.5%), one
Grade 3 and one Grade 4. 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.
Hyperthyroidism occurred in 5 (1.2%) of 411 patients, including
Grade 2 or 3 cases in 2 (0.5%) and 1 (0.2%) patients respectively,
receiving KEYTRUDA. Hypothyroidism occurred in 34 (8.3%) of 411
patients, including a Grade 3 case in 1 (0.2%) patient, receiving
KEYTRUDA. Thyroid disorders can occur at any time during treatment.
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 corticosteroids for Grade 3 or greater
hyperthyroidism. Withhold KEYTRUDA for Grade 3; permanently
discontinue KEYTRUDA for Grade 4 hyperthyroidism. Isolated
hypothyroidism may be managed with replacement therapy without
treatment interruption and without corticosteroids.
Other clinically important immune-mediated adverse reactions can
occur. The following clinically significant, immune-mediated
adverse reactions occurred in less than 1% of patients treated with
KEYTRUDA: exfoliative dermatitis, uveitis, arthritis, myositis,
pancreatitis, hemolytic anemia, partial seizures arising in a
patient with inflammatory foci in brain parenchyma, adrenal
insufficiency, myasthenic syndrome, optic neuritis, and
rhabdomyolysis.
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 of the adverse
reaction to Grade 1 or less, initiate corticosteroid taper and
continue to taper over at least 1 month. Restart KEYTRUDA if the
adverse reaction remains at Grade 1 or less. Permanently
discontinue KEYTRUDA for any severe or Grade 3 immune-mediated
adverse reaction that recurs and for any life-threatening
immune-mediated adverse reaction.
Based on its mechanism of action, KEYTRUDA may 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.
For the treatment of advanced melanoma, KEYTRUDA was
discontinued for adverse reactions in 6% of 89 patients who
received the recommended dose of 2 mg/kg and 9% of 411 patients
across all doses studied. Serious adverse reactions occurred in 36%
of patients receiving KEYTRUDA. The most frequent serious adverse
drug reactions reported in 2% or more of patients were renal
failure, dyspnea, pneumonia, and cellulitis.
The most common adverse reactions (reported in ≥20% of patients)
were fatigue (47%), cough (30%), nausea (30%), pruritus (30%), rash
(29%), decreased appetite (26%), constipation (21%), arthralgia
(20%), and diarrhea (20%).
The recommended dose of KEYTRUDA is 2 mg/kg administered as an
intravenous infusion over 30 minutes every three weeks until
disease progression or unacceptable toxicity. No formal
pharmacokinetic drug interaction studies have been conducted with
KEYTRUDA. 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. Safety and
effectiveness of KEYTRUDA have not been established in pediatric
patients.
About NanoString Technologies, Inc.
NanoString Technologies provides life science tools for
translational research and molecular diagnostic products. The
company's nCounter Analysis System has been employed in life
sciences research since it was first introduced in 2008 and has
been cited in over 700 peer-reviewed publications. The nCounter
Analysis System offers a cost-effective way to easily profile the
expression of hundreds of genes, proteins, miRNAs, or copy number
variations, simultaneously with high sensitivity and precision,
facilitating a wide variety of basic research and translational
medicine applications, including biomarker discovery and
validation. The company's technology has also been applied to
diagnostic use. The Prosigna Breast Cancer Prognostic Gene
Signature Assay together with the nCounter Dx Analysis System is
FDA 510(k) cleared for use as a prognostic indicator for distant
recurrence of breast cancer. For more information, please
visit www.nanostring.com.
NanoString Technologies, Inc. Forward-Looking
Statement
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements regarding the likelihood of this
collaboration to translate genomic discoveries to diagnostic
assays, and the potential to develop diagnostic assays on the
nCounter platform that will predict response to KEYTRUDA and other
anti-PD-1 therapies. Forward-looking statements are subject to
risks and uncertainties that could cause actual results to differ
materially and reported results should not be considered as an
indication of future performance. These risks and uncertainties
include, but are not limited to: risks associated with keeping pace
with rapidly changing technology and customer requirements; risks
regarding the company's ability to successfully introduce new
products; risks that new market opportunities may not develop as
quickly as expected; risks associated with competition in marketing
and selling products; risks of increased regulatory requirements;
as well as the other risks set forth in the company's filings with
the Securities and Exchange Commission. These forward-looking
statements speak only as of the date hereof. NanoString
Technologies disclaims any obligation to update these
forward-looking statements.
The NanoString
Technologies logo, NanoString, NanoString
Technologies, nCounter and Prosigna are either registered
trademarks or trademarks of NanoString Technologies, Inc.
Merck’s Focus on Cancer
Our goal is to translate breakthrough science into innovative
oncology medicines to help people with cancer worldwide. At Merck
Oncology, 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. For more
information about our oncology clinical trials, visit
www.merck.com/clinicaltrials.
About Merck
Today's Merck is a global healthcare leader working to help the
world be well. Merck is known as MSD outside of the United States
and Canada. 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 healthcare through far-reaching policies, programs and
partnerships. For more information, visit www.merck.com and connect
with us on Twitter, Facebook and YouTube.
Merck Forward-Looking Statement
This news release includes “forward-looking statements” within
the meaning of the safe harbor provisions of the United States
Private Securities Litigation Reform Act of 1995. These statements
are based upon the current beliefs and expectations of Merck’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 healthcare
legislation in the United States and internationally; global trends
toward healthcare cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; Merck’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 Merck’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
Merck 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 Merck’s 2014 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 the Medication Guide for KEYTRUDA at
http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf
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version on businesswire.com: http://www.businesswire.com/news/home/20150528005740/en/
Merck Media Relations:Pamela Eisele, 267-305-3558Claire
Mulhearn, 908-236-1118orMerck Investor Relations:Justin Holko,
908-740-1879orNanoString Investor/Media Relations:Leigh Salvo,
415-513-1281
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