First-Time Presentation of KEYTRUDA Compared
to Chemotherapy in Advanced Non-Small Cell Lung Cancer From
KEYNOTE-010 Study
New Findings of KEYTRUDA in Novel
Combinations with Other Immunotherapies in Advanced
Melanoma
First-Time Findings in Multiple Myeloma and
ER-Positive/HER2-Negative Breast Cancer as Well as New Findings in
Classical Hodgkin Lymphoma
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced that data investigating the use of
KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in
advanced non-small cell lung cancer, melanoma, classical Hodgkin
lymphoma, multiple myeloma, and ER-positive/HER2-negative breast
cancer will be presented at four medical congresses through the end
of this year. In total, data from more than 30 abstracts will be
presented at the Society for Melanoma Research (SMR) 2015 Congress
in San Francisco, Nov. 18 – 21; the 57th American Society of
Hematology (ASH) Annual Meeting in Orlando, Florida, Dec. 5 – 8;
the San Antonio Breast Cancer Symposium (SABCS), Dec. 8 – 12; and
the European Society for Medical Oncology (ESMO) Asia 2015 Congress
in Singapore, Dec. 18 – 21. By the end of 2015, data on the
anti-tumor activity of KEYTRUDA will have been presented across
more than 20 tumor types.
“The field of immuno-oncology holds great potential across a
broad spectrum of cancers,” said Dr. Roy Baynes, senior vice
president and head of global clinical development, Merck Research
Laboratories. “Data for KEYTRUDA being presented at these
scientific meetings include a first-time comparison to chemotherapy
in advanced non-small cell lung cancer, novel combination data in
advanced melanoma as well as first-time data in two additional
tumor types, namely multiple myeloma and hormone receptor positive
breast cancer, further demonstrating our deep commitment to
advancing cancer treatment.”
The KEYTRUDA clinical development program to date includes
patients with more than 30 tumor types in more than 160 clinical
trials, including more than 80 trials that combine KEYTRUDA with
other cancer treatments.
A select list of KEYTRUDA data to be presented at these meetings
includes:
SMR (data to be presented include three late breaking oral
presentations and multiple posters on KEYTRUDA monotherapy)
- Late Breaker Oral Presentation:
Preliminary Data From a Phase 1/2 Study of Epacadostat
(INCB024360) with Pembrolizumab as First-Line Treatment in Patients
with Advanced/Metastatic Melanoma. O. Hamid. Saturday, Nov. 21,
2:50 p.m. PST. Location: Salon 9-15 (San Francisco Marriott
Marquis).
- Late Breaker Oral Presentation:
Primary Analysis of MASTERKEY-265 Phase 1b Study of Talimogene
Laherparepvec (T-VEC) and Pembrolizumab (pembro) for Unresectable
Stage IIIB-IV Melanoma. G. Long. Saturday, Nov. 21, 3:20 p.m.
PST. Location: Salon 9-15 (San Francisco Marriott Marquis).
- Late Breaker Oral Presentation:
KEYNOTE-029: Pembrolizumab (pembro) + Low-Dose Ipilimumab (ipi)
For Advanced Melanoma. G. Long. Saturday, Nov. 21, 2:00 p.m.
PST. Location: Salon 9-15 (San Francisco Marriott Marquis).
For more information about this congress, including a complete
list of abstract titles, please visit the SMR 2015 website at
www.melanomacongress.com.
ASH (data to be presented include four oral presentations and
one poster presentation, including updated findings in classical
Hodgkin lymphoma and first-time findings in multiple
myeloma)
- (Abstract #505) Oral
Presentation: Pembrolizumab in Combination with Lenalidomide
and Low-Dose Dexamethasone for Relapsed/Refractory Multiple Myeloma
(RRMM): Keynote-023. J. San Miguel. Monday, Dec. 7, 7:00 a.m.
EST. Location: Hall E1 (Orange County Convention Center).
- (Abstract #584) Oral
Presentation: PD-1 Blockade With Pembrolizumab in Patients
With Classical Hodgkin Lymphoma After Brentuximab Vedotin Failure:
Safety, Efficacy, and Biomarker Assessment. P. Armand. Monday,
Dec. 7, 10:45 a.m. EST. Location: Hall E2 (Orange County Convention
Center).
For more information about this congress, including a complete
list of abstract titles, please visit the ASH Annual Meeting
website at www.hematology.org/Annual-Meeting.
SABCS (data to be presented include one oral presentation and
three poster presentations, including first-time findings in
ER-positive/HER2-negative breast cancer)
- (Abstract #S5-07) Oral
Presentation: Preliminary Efficacy and Safety of
Pembrolizumab (MK-3475) in Patients with PD-L1–positive, Estrogen
Receptor-positive (ER+)/HER2-negative Advanced Breast Cancer
Enrolled in KEYNOTE-028. H. Rugo. Friday, Dec. 11, 11:00 a.m.
CST. Location: Hall D (Henry B. Gonzalez Convention Center).
For more information about this congress, including a complete
list of abstract titles, please visit the SABCS website at
www.sabcs.org.
ESMO Asia (data to be presented include one oral presentation
featured in the Presidential Symposium, one proffered paper
presentation and seven poster presentations, including data
comparing KEYTRUDA to chemotherapy in advanced non-small cell lung
cancer)
- (Abstract #LBA3) Presidential
Symposium: KEYNOTE-010: Phase 2/3 Study of Pembrolizumab
(MK-3475) vs Docetaxel for PD-L1–Positive NSCLC After
Platinum-Based Therapy. R. Herbst. Sunday, Dec. 20, 5:00 p.m.
SGT. Location: Hall 406 (Suntec Convention & Exhibition
Centre).
- (Abstract #315O) Proffered Paper
Presentation: Antitumor Activity and Safety of Pembrolizumab
in Patients with PD-L1-positive Nasopharyngeal Carcinoma: Interim
Results From a Phase 1b Study. C. Hsu. Friday, Dec. 18, 2:50
p.m. SGT. Location: Hall 332 (Suntec Convention & Exhibition
Centre).
For more information about this congress, including a complete
list of abstract titles, please visit the ESMO Asia 2015 congress
website at
http://www.esmo.org/Conferences/ESMO-Asia-2015-Congress.
About KEYTRUDA® (pembrolizumab) Injection 100
mg
KEYTRUDA is a humanized monoclonal antibody that works by
increasing the ability of the body’s immune system to help detect
and fight tumor cells. KEYTRUDA 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.
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 metastatic non-small cell
lung cancer (NSCLC) whose tumors express PD-L1 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
is also indicated at the same dosing for the treatment of patients
with unresectable or metastatic melanoma and disease progression
following ipilimumab and, if BRAF V600 mutation positive, a BRAF
inhibitor. These indications are 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 these indications may be
contingent upon verification and description of clinical benefit in
the confirmatory trials.
Selected Important Safety Information for KEYTRUDA
(pembrolizumab)
Pneumonitis, including fatal cases, occurred in patients
receiving KEYTRUDA. Pneumonitis occurred in 12 (2.9%) of 411
melanoma patients, including Grade 2 or 3 cases in 8 (1.9%) and 1
(0.2%) patients, respectively, receiving KEYTRUDA. Pneumonitis
occurred in 19 (3.5%) of 550 patients with NSCLC, including Grade 2
(1.1%), 3 (1.3%), 4 (0.4%), or 5 (0.2%) pneumonitis in patients,
receiving KEYTRUDA. 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.
Colitis (including microscopic colitis) occurred in 4 (1%) of
411 patients with melanoma, including Grade 2 or 3 cases in 1
(0.2%) and 2 (0.5%) patients, respectively, receiving KEYTRUDA.
Colitis occurred in 4 (0.7 %) of 550 patients with NSCLC, including
Grade 2 (0.2%) or 3 (0.4%) colitis in patients 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 occurred in patients receiving KEYTRUDA. Hepatitis
(including autoimmune hepatitis) occurred in 2 (0.5%) of 411
patients with melanoma, 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 with melanoma,
including a Grade 2 case in 1 and a Grade 4 case in 1 (0.2% each)
patient, receiving KEYTRUDA. Hypophysitis occurred in 1 (0.2 %) of
550 patients with NSCLC, which was Grade 3 in severity. Monitor
patients for signs and symptoms of hypophysitis (including
hypopituitarism and adrenal insufficiency). Administer
corticosteroids and hormone replacement as indicated. Withhold
KEYTRUDA for Grade 2 and withhold or discontinue for Grade 3 or
Grade 4 hypophysitis.
Hyperthyroidism occurred in 5 (1.2%) of 411 patients with
melanoma, 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 with melanoma, including a Grade 3
case in 1 (0.2%) patient, receiving KEYTRUDA. Hyperthyroidism
occurred in 10 (1.8%) of 550 patients with NSCLC, including Grade 2
(0.7%) or 3 (0.3%). Hypothyroidism occurred in 38 (6.9%) of 550
patients with NSCLC, including Grade 2 (5.5%) or 3 (0.2%). 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 replacement hormones for hypothyroidism and
manage hyperthyroidism with thionamides and beta-blockers as
appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or Grade
4 hyperthyroidism.
Type 1 diabetes mellitus, including diabetic ketoacidosis, has
occurred in patients receiving KEYTRUDA. Monitor patients for
hyperglycemia or other signs and symptoms of diabetes. Administer
insulin for type 1 diabetes, and withhold KEYTRUDA and administer
anti-hyperglycemics in patients with severe hyperglycemia.
Nephritis occurred in patients receiving KEYTRUDA. Nephritis
occurred in 3 (0.7%) patients with melanoma, 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.
Other clinically important immune-mediated adverse reactions can
occur. 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. Resume KEYTRUDA when the
adverse reaction remains at Grade 1 or less following steroid
taper. Permanently discontinue KEYTRUDA for any severe or Grade 3
immune-mediated adverse reaction that recurs and for any
life-threatening immune-mediated adverse reaction.
Across clinical studies with KEYTRUDA, the following clinically
significant, immune-mediated adverse reactions have occurred:
bullous pemphigoid and Guillain-Barré syndrome. The following
clinically significant, immune-mediated adverse reactions occurred
in less than 1% of patients with melanoma treated with KEYTRUDA:
exfoliative dermatitis, uveitis, arthritis, myositis, pancreatitis,
hemolytic anemia, and partial seizures arising in a patient with
inflammatory foci in brain parenchyma. The following clinically
significant, immune-mediated adverse reactions occurred in less
than 1% of 550 patients with NSCLC treated with KEYTRUDA: rash,
vasculitis, hemolytic anemia, serum sickness, and myasthenia
gravis.
Infusion-related reactions, including severe and
life-threatening reactions, have occurred in patients receiving
KEYTRUDA. Monitor patients for signs and symptoms of infusion
related reactions including rigors, chills, wheezing, pruritus,
flushing, rash, hypotension, hypoxemia, and fever. For severe or
life-threatening reactions, stop infusion and permanently
discontinue KEYTRUDA.
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.
Among the 411 patients with metastatic melanoma, KEYTRUDA was
discontinued for adverse reactions in 9% of 411 patients. Adverse
reactions, reported in at least two patients, that led to
discontinuation of KEYTRUDA were: pneumonitis, renal failure, and
pain. Serious adverse reactions occurred in 36% of patients. The
most frequent serious adverse reactions, reported in 2% or more of
patients, were renal failure, dyspnea, pneumonia, and cellulitis.
The most common adverse reactions (reported in at least 20% of
patients) were fatigue (47%), cough (30%), nausea (30%), pruritus
(30%), rash (29%), decreased appetite (26%), constipation (21%),
arthralgia (20%), and diarrhea (20%).
Among the 550 patients with metastatic NSCLC, KEYTRUDA was
discontinued due to adverse reactions in 14% of patients. Serious
adverse reactions occurred in 38% of patients. The most frequent
serious adverse reactions reported in 2% or more of patients were
pleural effusion, pneumonia, dyspnea, pulmonary embolism, and
pneumonitis. The most common adverse reactions (reported in at
least 20% of patients) were fatigue (44%), decreased appetite
(25%), dyspnea (23%), and cough (29%).
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 and for 4 months
after the final dose.
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 health care 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 health care through far-reaching policies, programs and
partnerships. For more information, visit www.merck.com and connect
with us on Twitter, Facebook, YouTube and LinkedIn.
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 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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MerckMedia:Pamela Eisele, 267-305-3558Kim Hamilton,
908-740-1863orInvestors:Teri Loxam, 908-740-1986Justin Holko,
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