Merck’s KEYTRUDA® (pembrolizumab) Shows Superior Overall Survival Compared to Chemotherapy in Patients with Previously Treated Advanced Non-Small Cell Lung Cancer Whose Tumors Express PD-L1


October 26, 2015 9:00 am ET

Merck Plans Regulatory Submissions in the U.S. in late 2015 and in the European Union in Early 2016

Merck (NYSE: MRK), known as MSD outside the United States and Canada,
today announced topline results from the KEYNOTE-010 study of KEYTRUDA®
(pembrolizumab) in advanced non-small-cell lung cancer (NSCLC)
demonstrating that the trial met its primary objective.

KEYNOTE-010 is a randomized, pivotal Phase 2/3 trial comparing two doses
of KEYTRUDA (the FDA-approved 2mg/kg dose and a higher, investigational
10mg/kg dose, each given every 3 weeks), to docetaxel, a commonly used
chemotherapy. Patients were enrolled who had failed prior systemic
therapy for advanced NSCLC and whose tumors had PD-L1 (programmed death
ligand-1) expression tumor proportion scores (TPS) of 1 percent or more.
Outcomes were assessed in patients whose tumors were strongly PD-L1
positive (defined as TPS of 50 percent or more), and in all PD-L1
positive patients. A topline analysis revealed that treatment with
KEYTRUDA was associated with longer overall survival (OS) compared with
docetaxel treatment. This was true for both the approved and the
investigational dose of KEYTRUDA, which showed similar efficacy. It was
also true in both the first set of patients analyzed – those with a TPS
of 50 percent or greater – and for all enrolled patients, all of whom
had a TPS of 1 percent or greater. Treatment with KEYTRUDA, at both
doses, also provided superior progression-free survival (PFS) versus
that achieved following treatment with docetaxel in patients whose
tumors had TPS values equal to or greater than 50 percent. For PFS,
KEYTRUDA treatment was numerically but not statistically superior to
docetaxel in the all PD-L1 positive group, again at both doses. The
safety profile of KEYTRUDA in this trial was consistent with that
observed in previously reported studies in patients with advanced NSCLC.

“The results from this trial provide part of a growing body of evidence
supporting the potential of KEYTRUDA in the treatment of non-small-cell
lung cancer,” said Dr. Roger M. Perlmutter, president, Merck Research
Laboratories. “Advancing the standard of care in cancer requires a
collaborative effort, and we are grateful to the patients, institutions
and caregivers who participated in this study. We look forward to
sharing our complete data with the scientific community and with
regulatory agencies in the near future.”

About the KEYNOTE-010 Study

KEYNOTE-010 is a global, open-label, randomized, pivotal Phase 2/3 study
(, NCT01905657) evaluating two doses of KEYTRUDA (2
mg/kg or 10 mg/kg every three weeks) compared to docetaxel (75 mg/m^2
every three weeks) in 1034 patients with NSCLC who experienced disease
progression after platinum-containing systemic therapy and whose tumors
expressed PD-L1. The primary endpoints were OS and PFS. Tumor response
was assessed at week 12, then every 6 weeks thereafter per RECIST 1.1
criteria by independent, central, blinded, radiographic review and
investigator-assessed, immune-related response criteria.

About KEYTRUDA® (pembrolizumab) in the U.S.

In lung cancer, 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. In melanoma,
KEYTRUDA is indicated 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. The label for KEYTRUDA currently says that an
improvement in survival or disease-related symptoms has not yet been
established, and the continued approval for these indications may be
contingent upon verification and description of clinical benefit in the
confirmatory trials.

Selected Safety Information for KEYTRUDA®

Pneumonitis occurred in 19 (3.5%) of 550 patients, 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 occurred in 4 (0.7%) of 550 patients, 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 (pembrolizumab).
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 1 (0.2%) of 550 patients, 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

Hyperthyroidism occurred in 10 (1.8%) of 550 patients, including Grade 2
(0.7%) or 3 (0.3%). Hypothyroidism occurred in 38 (6.9%) of 550
patients, 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. 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.

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.

The following clinically significant, immune-mediated adverse reactions
occurred in patients treated with KEYTRUDA: rash, vasculitis, hemolytic
anemia, serum sickness, myasthenia gravis, bullous pemphigoid, and
Guillain-Barré syndrome.

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 (pembrolizumab).

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

The most common adverse reactions (reported in at least 20% of patients)
were fatigue (44%), decreased appetite (25%), dyspnea (23%), and cough

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.

About Lung Cancer

Lung cancer, which forms in the tissues of the lungs, usually within
cells lining the air passages, is the leading cause of cancer death
worldwide. Each year, more people die of lung cancer than die of colon,
breast, and prostate cancers combined. The two main types of lung cancer
are non-small-cell and small-cell. NSCLC is the most common type of lung
cancer, accounting for about 85 percent of all cases. The five-year
relative survival rate for patients suffering from highly advanced,
metastatic (Stage IV) lung cancers is estimated to be four percent.

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,

Merck’s Commitment to Access for KEYTRUDA

Merck provides multiple programs to help ensure patients who are
prescribed KEYTRUDA have access to our anti-PD-1 therapy. The Merck
Access Program
provides reimbursement support for eligible patients
receiving KEYTRUDA, including help with out-of-pocket costs and co-pay
assistance. Merck also offers financial assistance for eligible patients
who are uninsured through our patient assistance program. More
information is available by calling 1-855-257-3932 or visiting

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,
and connect with us on Twitter,
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This news release of Merck & Co., Inc., Kenilworth, NJ, USA (the
“company”) 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
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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
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pharmaceutical industry regulation and healthcare legislation in the
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including obtaining regulatory approval; the company’s ability to
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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 (

Please see Prescribing Information for KEYTRUDA (pembrolizumab) at
and the Medication Guide for KEYTRUDA at

Pamela Eisele, 267-305-3558
Courtney Ronaldo, 908-236-1108
Teri Loxam, 908-740-1986
Justin Holko, 908-740-1879

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