Data to be Presented Across Multiple Tumor
Types for KEYTRUDA and MK-8628 (OTX015), an Investigational
BET-Bromodomain Inhibitor
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced that new data evaluating KEYTRUDA®
(pembrolizumab), the company’s anti-PD-1 therapy, in both advanced
non-small cell lung cancer (NSCLC) and malignant pleural
mesothelioma will be presented as part of the Clinical Trials
Plenary Session on Sunday, April 19 at the American Association for
Cancer Research (AACR) Annual Meeting in Philadelphia, April 18 –
22.
The NSCLC data will be the first presentation of new efficacy
and safety findings for KEYTRUDA from 495 patients, including
validation of PD-L1 expression (abstract #CT104). These data are
from the largest, multi-center Phase 1b (KEYNOTE-001) study of an
anti-PD-1 therapy. With the mesothelioma findings (abstract
#CT103), data evaluating KEYTRUDA will have been presented in eight
different types of cancer.
“Our clinical program is investigating the potential of KEYTRUDA
in a broad range of cancers where innovative approaches are truly
needed – these data to be presented at AACR illustrate this
effort,” said Dr. Roger Dansey, senior vice president, Late-Stage
Oncology Clinical Development, Merck Research Laboratories. “At
AACR, we look forward to sharing new data for KEYTRUDA across a
range of challenging cancer types, especially in non-small cell
lung cancer and mesothelioma.”
Presentations of Merck Oncology Compounds
In total, data from 14 abstracts evaluating KEYTRUDA or MK-8628
(OTX015), Merck’s investigational BET-bromodomain inhibitor, will
be presented at AACR 2015. Pre-clinical and early phase data to be
presented span multiple tumor types – such as prostate cancer,
blood cancer and NSCLC. A full listing of abstracts included in the
2015 AACR program is below:
KEYTRUDA (pembrolizumab)
- (Abstract #CT104) Late-Breaker
Presentation: Efficacy of pembrolizumab (MK-3475) and
relationship with PD-L1 expression in patients with non-small cell
lung cancer (NSCLC): Findings from KEYNOTE-001. E. Garon.
Sunday, April 19, 1:05 PM EDT. Location: Terrace Ballroom I (400
Level).
- (Abstract #CT103) Late-Breaker
Presentation: Clinical safety and efficacy of pembrolizumab
(MK-3475) in patients with malignant pleural mesothelioma (MPM):
Preliminary results from KEYNOTE-028. E. Alley. Sunday, April
19, 12:45 PM EDT. Location: Terrace Ballroom I (400 Level).
- (Abstract #256) Poster
Presentation: Identification of additional cancers likely to
respond to anti-PD-1 therapy (pembrolizumab): Evaluation of PD-L1
expression in a large molecular tumor profiling gene expression
database. M. Ayers. Sunday, April 19, 1:00 PM-5:00 PM EDT.
Location: Section 12.
- (Abstract #269) Poster
Presentation: Evaluation of the antitumor activity of
anti-PD-1 immunotherapy as a single agent and in combination with
approved agents in preclinical tumor models. E. Pinheiro.
Sunday, April 19, 1:00 PM-5:00 PM EDT. Location: Section 12.
- (Abstract #570) Poster
Presentation: PD-L1 expression in paired non-small cell lung
cancer tumor samples. J. Kim. Sunday, April 19, 1:00 PM-5:00 PM
EDT. Location: Section 24.
- (Abstract #1307) Poster
Presentation: Assessment of gene expression in peripheral
blood from patients with advanced melanoma using RNA-seq before and
after treatment with anti-PD-1 therapy with pembrolizumab
(MK-3475). M. Ayers. Monday, April 20, 8:00 AM-12:00 PM EDT.
Location: Section 12.
- (Abstract #1328) Poster
Presentation: Molecular characterization of mouse syngeneic
tumor models in response to treatment with anti-PD-1
immunotherapy. H. Hirsch. Monday, April 20, 8:00 AM-12:00 PM
EDT. Location: Section 12.
- (Abstract #4303) Poster
Presentation: Programmed death ligand 1 (PD-L1) expression
in paired melanoma tumor samples. T. Steiniche. Tuesday, April
21, 1:00 PM-5:00 PM EDT. Location: Section 25.
MK-8628 (OTX015)
- (Abstract #2625) Poster
Presentation: Targeting prostate cancer stem cells (CSCs)
with the novel BET bromodomain (BRD) protein inhibitor OTX015.
G. Civenni. Monday, April 20, 1:00 PM-5:00 PM EDT. Location:
Section 30.
- (Abstract #3526) Poster
Presentation: OTX015 effects in triple-negative breast
cancer (TNBC) models are independent of hypoxia conditions and
synergistic with other anticancer agents. R. Vazquez. Tuesday,
April 21, 8:00 AM-12:00 PM EDT. Location: Section 28.
- (Abstract #3527) Poster
Presentation: OTX015, a novel BET-bromodomain (BET-BRD)
inhibitor, displays antitumoral effects in orthotopic and
heterotopic models of human glioblastoma. L. Astorgues-xerri.
Tuesday, April 21, 8:00 AM-12:00 PM EDT. Location: Section 28.
- (Abstract #3530) Poster
Presentation: Gene expression profile of OTX015, a BET
bromodomain inhibitor, in preclinical models of non-small-cell lung
cancer (NSCLC) and small-cell lung cancer (SCLC) models. M.
Riveiro. Tuesday, April 21, 8:00 AM-12:00 PM EDT. Location: Section
28.
- (Abstract #4511) Poster
Presentation: Pharmacokinetics of OTX015 in a phase Ib
dose-finding study of patients with hematologic malignancies:
Preliminary results of a population PK analysis. E. Odore.
Tuesday, April 21, 1:00 PM-5:00 PM EDT. Location: Section 32.
- (Abstract #4731) Minisymposium:
Targeting super-enhancer induced gene expression with the novel
BRD4 inhibitor OTX015 in preclinical models of MYCN-amplified
neuroblastoma. A. Henssen. Tuesday, April 21, 3:50 PM – 4:05 PM
EDT. Location: Room 120.
For more information including a complete list of abstract
titles, please visit the AACR website at http://www.aacr.org.
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 70 clinical trials – across
more than 30 tumor types and over 8,000 patients – both as a
monotherapy and in combination with other therapies.
About MK-8628 (OTX015)
MK-8628 (OTX015) is an investigational, novel oral BET
(bromodomain) inhibitor, which is currently in Phase 1b studies for
the treatment of hematological malignancies and advanced solid
tumors. BET proteins are considered potential therapeutic targets
in cancer, as they play a pivotal role in regulating the
transcription of key regulators of cancer cell growth and survival,
including c-Myc. Interim data from ongoing Phase 1 clinical studies
of MK-8628 have demonstrated meaningful clinical activity in
patients with hematological malignancies. An international,
open-label Phase 1 study evaluating MK-8628 in five different solid
tumors was initiated in November 2014.
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 biomedical
innovations to help people with cancer worldwide. For Merck
Oncology, helping people fight cancer is our passion, supporting
accessibility to our cancer medicines is our commitment, and
pursuing research in immuno-oncology and other areas of
breakthrough science is our focus 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
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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
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