New Findings Show Anti-tumor Activity of
KEYTRUDA in Five Additional Cancers: Colorectal, Esophageal,
Ovarian, Renal Cell Carcinoma and Small-Cell Lung Cancer
First-Time Presentations of DNA Mismatch
Repair Deficiency Data in Colorectal and other Cancers and
Nanostring RNA Data in Melanoma, Head and Neck and Gastric
Cancers
Industry-leading Number of PD-1 Clinical
Trials Resulting in Growing Body of Data for KEYTRUDA across 13
Tumor Types
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced that new investigational data in 10
different types of cancer from the company’s immuno-oncology
development program evaluating its anti-PD-1 therapy, KEYTRUDA®
(pembrolizumab), will be presented at the 51st Annual Meeting of
the American Society of Clinical Oncology (ASCO) in Chicago, May 29
– June 2, 2015. Merck is advancing a comprehensive clinical
development program for KEYTRUDA, a fact reflected in the more than
40 abstracts accepted for this year’s ASCO meeting, including 11
oral presentations of which two are late-breakers (Abstract
#LBA6008 and #LBA100) selected for the official ASCO press program
on Friday, May 29.
“At Merck, we are executing a broad and deep immuno-oncology
research program – now in more than 85 studies and 30 different
tumor types – to understand the potential for KEYTRUDA in a broad
range of cancers, at different stages, lines of therapy, both alone
and in combination," said Dr. Roy Baynes, senior vice president and
head of global clinical development, Merck Research Laboratories.
“This commitment to breakthrough science has thus far yielded data
supporting the potential of KEYTRUDA in 13 different cancers. With
our collaborators in the cancer community, we remain focused on
pursuing our clinical research program with the goal of advancing
therapies with meaningful benefit to patients with cancer.”
Merck’s Immuno-Oncology Data at 2015 ASCO Annual
Meeting
First-time presentation of findings with KEYTRUDA are
anticipated in five additional tumor types – colorectal,
esophageal, ovarian, renal cell carcinoma (RCC) and small-cell lung
cancer (SCLC) – as well as new data in advanced bladder, gastric,
head and neck, melanoma and non-small cell lung cancer (NSCLC).
These studies will evaluate KEYTRUDA as monotherapy and in
combination with other therapies – including across different
patient sub-groups, lines of therapy and based on biomarker
expression. There will be first-time presentations of data for
KEYTRUDA that evaluate nanostring RNA signatures and DNA mismatch
repair deficiency as potential biomarkers for improved efficacy
across different types of cancer. A select list of sessions,
including oral presentations, clinical science symposia and poster
discussions, included in the 2015 ASCO program is provided
below.
Head and Neck Cancer
New results for KEYTRUDA will be presented in advanced head and
neck cancer, including data from an expansion cohort of the
KEYNOTE-012 trial as an oral late-breaker presentation. These data
are part of the official ASCO press program.
- (Abstract #LBA6008) Late-Breaker
Presentation: Antitumor activity and safety of pembrolizumab
in patients (pts) with advanced squamous cell carcinoma of the head
and neck (SCCHN): Preliminary results from KEYNOTE-012 expansion
cohort. T. Seiwert. Monday, June 1, 3:39 PM – 3:51 PM CDT.
Location: S100bc. ASCO Press Program, Friday, May 29, 1:00 PM
CDT.
- (Abstract #6017) Poster Discussion:
Inflamed-phenotype gene expression signatures to predict benefit
from the anti-PD-1 antibody pembrolizumab in PD-L1+ head and neck
cancer patients. T. Seiwert. Saturday, May 30, 1:15 PM – 4:45
PM CDT (poster session). Location: S Hall A. 4:45 PM – 6:00 PM CDT
(discussion). Location: S406.
Melanoma
Merck has a broad development program in melanoma evaluating
KEYTRUDA across multiple stages of disease, lines of therapy and in
combination with other anti-cancer agents. KEYTRUDA was the first
anti-PD-1 therapy approved in the United States and is currently
indicated in the United States at a 2 mg/kg dose 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. Please see below for
complete indication and selected safety information for KEYTRUDA.
At ASCO, data evaluating KEYTRUDA in advanced melanoma will be the
subject of three oral presentations and several poster
discussions.
- (Abstract #9005) Oral
Presentation: Long-term efficacy of pembrolizumab (pembro;
MK-3475) in a pooled analysis of 655 patients (pts) with advanced
melanoma (MEL) enrolled in KEYNOTE-001. A. Daud. Saturday, May
30, 2:39 PM – 2:51 PM CDT. Location: E354b.
- (Abstract #3000) Oral
Presentation: Atypical patterns of response in patients (pts)
with metastatic melanoma treated with pembrolizumab (MK-3475) in
KEYNOTE-001. J. Wolchok. Monday, June 1, 1:15 PM – 1:27 PM CDT.
Location: S406.
- (Abstract #3001) Oral
Presentation: Association of response to programmed death
receptor 1 (PD-1) blockade with pembrolizumab (MK-3475) with an
interferon-inflammatory immune gene signature. A. Ribas.
Monday, June 1, 1:27 PM – 1:39 PM CDT. Location: S406.
- (Abstract #3009) Poster Discussion:
Pembrolizumab (MK-3475) plus low-dose ipilimumab (IPI) in patients
(pts) with advanced melanoma (MEL) or renal cell carcinoma (RCC):
Data from the KEYNOTE-029 phase 1 study. M. Atkins. Saturday,
May 30, 8:00 AM – 11:30 AM CDT (poster session). Location: S Hall
A. 3:00 PM – 4:15 PM CDT (discussion). Location: S406.
Lung Cancer
Merck has a broad lung cancer development program for KEYTRUDA
across all histologies, multiple lines of therapy and in
combination, and based on tumor characteristics such as PD-L1
expression. At ASCO, first-time presentations include early
findings with KEYTRUDA monotherapy in SCLC and as combination
therapy in NSCLC.
- (Abstract #8011) Clinical Science
Symposium: Phase I study of pembrolizumab (pembro; MK-3475)
plus ipilimumab (IPI) as second-line therapy for advanced non-small
cell lung cancer (NSCLC): KEYNOTE-021 cohort D. A. Patnaik.
Sunday, May 31, 4:54 PM – 5:06 PM CDT. Location: E Hall D1.
- (Abstract #7502) Oral
Presentation: Pembrolizumab (MK-3475) in patients (pts) with
extensive-stage small cell lung cancer (SCLC): Preliminary safety
and efficacy results from KEYNOTE-028. P. Ott. Saturday, May
30, 3:48 PM – 4:00 PM CDT. Location: E Hall D1.
Additional Cancers
Early data for KEYTRUDA from Merck’s immuno-oncology development
program will also be presented in a number of difficult-to-treat
cancers. For the first time, data will be presented exploring the
potential of an anti-PD-1 therapy in colorectal cancer and other
solid tumors based on DNA mismatch repair deficiency, which is
evident in different cancers. These data are part of the official
ASCO press program.
- (Abstract #LBA100) Late-Breaker
Presentation: PD-1 blockade in tumors with mismatch repair
deficiency. D. Le. Saturday, May 30, 8:05 AM – 8:17 AM CDT.
Location: E Hall D1. ASCO Press Program, Friday, May 29, 1:00 PM
CDT.
- (Abstract #4001) Oral
Presentation: Relationship between PD-L1 expression and
clinical outcomes in patients with advanced gastric cancer treated
with the anti-PD-1 monoclonal antibody pembrolizumab (MK-3475) in
KEYNOTE-012. Y. Bang. Sunday, May 31, 8:12 AM – 8:24 AM CDT.
Location: E Hall D2.
- (Abstract #4010) Clinical Science
Symposium: Pembrolizumab (MK-3475) for patients (pts) with
advanced esophageal carcinoma: Preliminary results from
KEYNOTE-028. T. Doi. Sunday, May 31, 4:54 PM – 5:06 PM CDT.
Location: E Hall D2.
- (Abstract #4502) Oral
Presentation: Pembrolizumab (MK-3475) for advanced urothelial
cancer: Updated results and biomarker analysis from
KEYNOTE-012. E. Plimack. Monday, June 1, 10:09 AM – 10:21 AM
CDT. Location: E Arie Crown Theater.
- (Abstract #5510) Clinical Science
Symposium: Antitumor activity and safety of pembrolizumab in
patients (pts) with PD-L1 positive advanced ovarian cancer: Interim
results from a phase Ib study. A. Varga. Monday, June 1, 3:12
PM – 3:24 PM CDT. Location: E354b.
Additional Data
Data from studies of other Merck approved medicines and pipeline
candidates will also be presented at the meeting. For more
information, including a complete list of abstract titles, please
visit the ASCO website at https://iplanner.asco.org/AM2015.
Merck Oncology Briefing Webcast
Merck will hold a webcast in conjunction with the 2015 ASCO
Annual Meeting on June 1 at 7:30 p.m. CDT. Investors and
journalists may access the live audio webcast of the event on
Merck’s website at www.merck.com. Software needed to listen to the
webcast is available on the corporate website and should be
downloaded prior to the beginning of the webcast. Institutional
investors, analysts and members of the media can also listen to the
event by dialing (866) 486-2604 or (706) 634-1286 and using ID code
number 45855476.
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 85 clinical trials – across
more than 30 tumor types and over 14,000 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.
Our 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 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.
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.
MerckMedia:Pamela Eisele, 267-305-3558Claire Mulhearn,
908-236-1118orInvestors:Joseph Romanelli, 908-740-1986Justin Holko,
908-740-1879
Merck (NYSE:MRK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Merck (NYSE:MRK)
Historical Stock Chart
From Apr 2023 to Apr 2024