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December 18, 2015 4:05 pm ET

KEYTRUDA is Now the First and Only Anti-PD-1 Therapy to Achieve Superior Overall Survival Compared to Ipilimumab

Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that the U.S. Food and Drug Administration (FDA) has
approved an expanded indication for KEYTRUDA^® (pembrolizumab),
the company’s anti-PD-1 (programmed death receptor-1) therapy, to
include the first-line treatment of patients with unresectable or
metastatic melanoma. This approval marks the second FDA-approved
indication in advanced melanoma for KEYTRUDA, which is now the first
anti-PD-1 therapy approved for previously untreated advanced melanoma
patients regardless of BRAF status. The FDA-approved dose of KEYTRUDA is
2 mg/kg every three weeks.

In a Phase 3 trial, KEYNOTE-006, patients with unresectable or
metastatic melanoma who were treated with KEYTRUDA experienced superior
overall survival (OS) compared to those treated with ipilimumab. In this
study supporting the first-line approval, patients given KEYTRUDA 10
mg/kg every two weeks demonstrated a 37 percent reduction in the risk of
death and those given KEYTRUDA 10 mg/kg every three weeks demonstrated a
31 percent reduction in the risk of death, both compared to ipilimumab
(hazard ratio: 0.63 [95% CI: 0.47, 0.83; p<0.001] and hazard ratio: 0.69
[95% CI: 0.52, 0.90; p=0.004], respectively).

Immune-mediated adverse reactions occurred with KEYTRUDA including
pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. Based
on the severity of the adverse reaction, KEYTRUDA should be withheld or
discontinued and corticosteroids administered. For more information
regarding immune-mediated adverse reactions, see “Selected Important
Safety Information” below.

“As recently as five years ago, there were few treatment options for
patients suffering from advanced melanoma,” said Dr. Roger M.
Perlmutter, president, Merck Research Laboratories. “Today’s news is
another exciting milestone for KEYTRUDA and for patients with this
disease. Data supporting the approval emerged from a large and diverse
patient population, including patients with very advanced disease and
patients whose tumors carried BRAF mutations, thus demonstrating both
the breadth of our clinical development program for KEYTRUDA, and the
potential of KEYTRUDA to extend the lives of those afflicted with this
grievous malignancy.”

KEYTRUDA (pembrolizumab) 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.

“This growing body of evidence in patients with advanced melanoma
supports the expanded indication for KEYTRUDA,” said Dr. Omid Hamid,
Director of the Melanoma Center at The Angeles Clinic and Research
Institute, and a principal investigator for the KEYTRUDA melanoma
clinical program. “This approval highlights the importance of KEYTRUDA
for advanced melanoma, where we are in need of additional treatment
options.”

Data Supporting First-Line Indication in Advanced Melanoma and
KEYTRUDA Full Approval

The approval was based on data from a multicenter, controlled, Phase 3
study, KEYNOTE-006, which evaluated KEYTRUDA compared to ipilimumab in
834 patients with unresectable or metastatic melanoma with progression
of disease; no prior therapy with ipilimumab; and prior therapy with at
most one other systemic treatment. Patients were randomized (1:1:1) to
receive KEYTRUDA at a dose of 10 mg/kg every two (n=279) or three weeks
(n=277) until disease progression or unacceptable toxicity, or
ipilimumab, the standard of care at the time of the study, at a dose of
3 mg/kg every three weeks for four doses unless discontinued earlier for
disease progression or unacceptable toxicity (n=278). The primary
efficacy outcome measures were OS and progression-free survival (PFS)
(as assessed by Blinded Independent Central Review (BICR) using Response
Evaluation Criteria in Solid Tumors (RECIST) v1.1). Secondary efficacy
outcome measures were overall response rate (ORR) and response duration.
KEYTRUDA 10 mg/kg every two or three weeks showed superior OS compared
to ipilimumab (hazard ratio: 0.63 [95% CI: 0.47, 0.83; p<0.001] and
hazard ratio: 0.69 [95% CI: 0.52, 0.90; p=0.004], respectively). Median
PFS was 5.5 months (95% CI: 3.4, 6.9), 4.1 months (95% CI: 2.9, 6.9),
and 2.8 months (95% CI: 2.8, 2.9) with KEYTRUDA 10 mg/kg every two
weeks, KEYTRUDA 10 mg/kg every three weeks and ipilimumab, respectively.
For PFS, both schedules for KEYTRUDA 10 mg/kg every two or three weeks
resulted in superior outcomes compared to ipilimumab (hazard ratio: 0.58
[95% CI: 0.46, 0.72; p<0.001] and hazard ratio: 0.58 [95% CI: 0.47,
0.72; p<0.001], respectively). KEYTRUDA every two or three weeks
demonstrated a 42 percent reduction in the risk of disease progression
or death as compared to ipilimumab. The ORR was 34 percent (95% CI: 28,
40) with KEYTRUDA 10 mg/kg every two weeks and 33 percent (95% CI: 27,
39) with KEYTRUDA (pembrolizumab) 10 mg/kg every three weeks, as
compared with 12 percent (95% CI: 8, 16) with ipilimumab. KEYTRUDA 10
mg/kg every two weeks and three weeks achieved partial response rates of
29 percent and 27 percent, respectively, and complete response rates of
5 percent and 6 percent, respectively; there was a 10 percent partial
response rate and 1 percent complete response rate for ipilimumab. Among
the 94 patients randomized to KEYTRUDA 10 mg/kg every two weeks with an
objective response, response durations ranged from 1.4+ to 8.2 months.
Among the 91 patients randomized to KEYTRUDA 10 mg/kg every three weeks
with an objective response, response durations ranged from 1.4+ to 8.1+
months.

Eighty percent of patients had PD-L1 positive melanoma, 18 percent had
PD-L1 negative melanoma, and 2 percent had unknown PD-L1 status
(positive: greater than or equal to 1 percent of tumor cells using an
Investigational Use Only assay). BRAF mutations were reported in 36
percent of patients, of which 46 percent were previously treated with a
BRAF-inhibitor. Patients with BRAF V600E mutated melanoma were not
required to have received prior BRAF inhibitor therapy.

The most commonly reported adverse reactions were fatigue (28% with
KEYTRUDA vs. 28% with ipilimumab), diarrhea (26% with KEYTRUDA), rash
(24% with KEYTRUDA vs. 23% with ipilimumab), and nausea (21% with
KEYTRUDA). Corresponding incidence rates are listed for ipilimumab only
for those adverse reactions that occurred at the same or lower rate than
with KEYTRUDA.

Severe and life-threatening infusion-related reactions have been
reported in 3 (0.1%) of 2,117 patients. Monitor patients for signs and
symptoms of infusion related reactions including rigors, chills,
wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever.
For Grade 3 or 4 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 four months
after the last dose of KEYTRUDA.

FDA Approves Labeling Update in Advanced Melanoma: Supporting Data
from KEYNOTE-002

Additionally, the FDA approved an update to the product labeling for
KEYTRUDA for the treatment of patients with ipilimumab-refractory
advanced melanoma. This update is based on results from the randomized
Phase 2 trial, KEYNOTE-002, which demonstrated KEYTRUDA was superior to
investigator’s choice chemotherapy.

KEYNOTE-002 is a multicenter, randomized controlled study of KEYTRUDA
(pembrolizumab) 2 mg/kg every three weeks or 10 mg/kg every three weeks
compared to investigator‘s choice chemotherapy (dacarbazine,
temozolomide, carboplatin plus paclitaxel, paclitaxel, or carboplatin)
in 540 patients with unresectable or metastatic melanoma with
progression of disease; refractory to two or more doses of ipilimumab
and, if BRAF V600 mutation positive, a BRAF or MEK inhibitor; and
disease progression within 24 weeks following the last dose of
ipilimumab. Patients on chemotherapy who experienced progression of
disease were offered KEYTRUDA. Median PFS was 2.9 months (95% CI: 2.8,
3.8), 2.9 months (95% CI: 2.8, 4.7), and 2.7 months (95% CI: 2.5, 2.8)
with KEYTRUDA 2 mg/kg every three weeks (n=180), KEYTRUDA 10 mg/kg every
three weeks (n=181) and chemotherapy (n=179), respectively. Doses of
KEYTRUDA 2 mg/kg or 10 mg/kg every three weeks were superior compared to
chemotherapy for the PFS primary endpoint (hazard ratio: 0.57 [95% CI:
0.45, 0.73; p<0.001] and hazard ratio: 0.50 [95% CI: 0.39, 0.64;
p<0.001], respectively). KEYTRUDA 2 mg/kg every three weeks demonstrated
a 43 percent reduction in the risk of disease progression or death
compared to chemotherapy. There was no statistically significant
difference between KEYTRUDA and chemotherapy in the interim OS analysis.
The ORR was 21 percent (95% CI: 15, 28) with KEYTRUDA 2 mg/kg every
three weeks and 25 percent (95% CI: 19, 32) with KEYTRUDA 10 mg/kg every
three weeks, as compared with 4 percent (95% CI: 2, 9) with
chemotherapy. KEYTRUDA 2 mg/kg and 10 mg/kg every three weeks achieved
partial response rates of 19 percent and 23 percent, respectively, and
complete response rates of 2 percent and 3 percent, respectively; there
was a 4 percent partial response rate and no complete responses for
chemotherapy. Among the 38 patients randomized to KEYTRUDA 2 mg/kg with
an objective response, response durations ranged from 1.3+ to
11.5+ months. Among the 46 patients randomized to KEYTRUDA 10 mg/kg with
an objective response, response durations ranged from 1.1+ to
11.1+ months.

The most commonly reported adverse reactions were fatigue (43% with
KEYTRUDA), pruritus (28% with KEYTRUDA vs. 8% with chemotherapy), rash
(24% with KEYTRUDA vs. 8% with chemotherapy), constipation (22% with
KEYTRUDA vs. 20% with chemotherapy), nausea (22% with KEYTRUDA),
diarrhea (20% with KEYTRUDA vs. 20% with chemotherapy), and decreased
appetite (20% with KEYTRUDA). Corresponding incidence rates are listed
for chemotherapy only for those adverse reactions that occurred at the
same or lower rate than with KEYTRUDA.

KEYTRUDA was initially approved in 2014 under the FDA’s accelerated
approval process for the treatment of patients with unresectable or
metastatic melanoma and disease progression following ipilimumab and, if
BRAF V600 mutation positive, a BRAF inhibitor. At the time of the
initial approval, an improvement in survival or disease-related symptoms
was not established. In accordance with the accelerated approval
process, full approval was contingent upon verification and description
of clinical benefit, which has now been demonstrated in KEYNOTE-002 and
KEYNOTE-006.

Selected Important Safety Information for KEYTRUDA (pembrolizumab)

Immune-mediated pneumonitis, including fatal cases, occurred in patients
receiving KEYTRUDA. Pneumonitis occurred in 32 (2%) of 1,567 patients
with melanoma, including Grade 1 (0.8%), 2 (0.8%), and 3 (0.4%)
pneumonitis. Pneumonitis occurred in 19 (3.5%) of 550 patients with
non-small cell lung cancer (NSCLC), including Grade 2 (1.1%), 3 (1.3%),
4 (0.4%), or 5 (0.2%) pneumonitis. 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.

Immune-mediated colitis occurred in 31 (2%) of 1,567 patients with
melanoma, including Grade 2 (0.5%), 3 (1.1%), and 4 (0.1%) colitis.
Immune-mediated colitis occurred in 4 (0.7%) of 550 patients with NSCLC,
including Grade 2 (0.2%) or 3 (0.4%) colitis. 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.

Immune-mediated hepatitis occurred in 16 (1%) of 1,567 patients with
melanoma, including Grade 2 (0.1%), 3 (0.7%), and 4 (0.1%) hepatitis.
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 13 (0.8%) of 1,567 patients with melanoma,
including Grade 2 (0.3%), 3 (0.3%), and 4 (0.1%) hypophysitis.
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 clinically
indicated. Withhold KEYTRUDA for Grade 2; withhold or discontinue for
Grade 3 or 4 hypophysitis.

Hyperthyroidism occurred in 51 (3.3%) of 1,567 patients with melanoma,
including Grade 2 (0.6%) and 3 (0.1%) hyperthyroidism. Hypothyroidism
occurred in 127 (8.1%) of 1,567 patients with melanoma, including Grade
3 (0.1%) hypothyroidism. Hyperthyroidism occurred in 10 (1.8%) of 550
patients with NSCLC, including Grade 2 (0.7%) or 3 (0.3%)
hyperthyroidism. Hypothyroidism occurred in 38 (6.9%) of 550 patients
with NSCLC, including Grade 2 (5.5%) or 3 (0.2%) hypothyroidism. 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
(pembrolizumab) for Grade 3 or 4 hyperthyroidism.

Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 3
(0.1%) of 2,117 patients. 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.

Immune-mediated nephritis occurred in 7 (0.4%) of 1,567 patients with
melanoma, including Grade 2 (0.2%), 3 (0.2%) and Grade 4 (0.1%)
nephritis. 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 to Grade 1 or less, initiate
corticosteroid taper and continue to taper over at least 1 month. Based
on limited data from clinical studies in patients whose immune-related
adverse reactions could not be controlled with corticosteroid use,
administration of other systemic immunosuppressants can be considered.
Resume KEYTRUDA when the immune-mediated adverse reaction remains at
Grade 1 or less following corticosteroid taper. Permanently discontinue
KEYTRUDA for any 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 less than 1% (unless otherwise indicated) of 1567 patients
with melanoma: arthritis (1.6%), exfoliative dermatitis, bullous
pemphigoid, uveitis, myositis, Guillain-Barré syndrome, myasthenia
gravis, vasculitis, 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: rash, vasculitis,
hemolytic anemia, serum sickness, and myasthenia gravis.

Severe and life-threatening infusion-related reactions have been
reported in 3 (0.1%) of 2,117 patients. Monitor patients for signs and
symptoms of infusion related reactions including rigors, chills,
wheezing, pruritus, flushing, rash, hypotension, hypoxemia, and fever.
For Grade 3 or 4 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).

In Trial 6, KEYTRUDA was discontinued due to adverse reactions in 9% of
555 patients with advanced melanoma; adverse reactions leading to
discontinuation in more than one patient were colitis (1.4%), autoimmune
hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and
cardiac failure (0.4%). Adverse reactions leading to interruption of
KEYTRUDA occurred in 21% of patients; the most common (≥1%) was diarrhea
(2.5%). The most common adverse reactions were fatigue (28% with
KEYTRUDA vs. 28% with ipilimumab), diarrhea (26% with KEYTRUDA), rash
(24% with KEYTRUDA vs. 23% with ipilimumab), and nausea (21% with
KEYTRUDA). Corresponding incidence rates are listed for ipilimumab only
for those adverse reactions that occurred at the same or lower rate than
with KEYTRUDA.

In Trial 2, KEYTRUDA was discontinued due to adverse reactions in 12% of
357 patients with advanced melanoma; the most common (≥1%) were general
physical health deterioration (1%), asthenia (1%), dyspnea (1%),
pneumonitis (1%), and generalized edema (1%). Adverse reactions leading
to interruption of KEYTRUDA occurred in 14% of patients; the most common
(≥1%) were dyspnea (1%), diarrhea (1%), and maculo-papular rash (1%).
The most common adverse reactions were fatigue (43% with KEYTRUDA),
pruritus (28% with KEYTRUDA vs. 8% with chemotherapy), rash (24% with
KEYTRUDA vs. 8% with chemotherapy), constipation (22% with KEYTRUDA vs.
20% with chemotherapy), nausea (22% with KEYTRUDA), diarrhea (20% with
KEYTRUDA vs. 20% with chemotherapy), and decreased appetite (20% with
KEYTRUDA). Corresponding incidence rates are listed for chemotherapy
only for those adverse reactions that occurred at the same or lower rate
than with KEYTRUDA.

KEYTRUDA was discontinued due to adverse reactions in 14% of 550
patients with NSCLC. 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%), cough (29%), and dyspnea (23%).

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.

Merck’s Commitment to Patients

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 www.merckaccessprogram-keytruda.com.

Merck also offers a 24/7 Patient Support program called KEY+YOU. The
KEY+YOU program is staffed by compassionate nurses offering patients
phone calls, email check-ins, wellness support, and referrals to
community/peer groups as part of a comprehensive plan of support. A
patient may enroll in the program by dialing 1-85-KEYTRUDA or visiting www.Keytruda.com.

About KEYTRUDA^® (pembrolizumab) Injection
100 mg

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.

KEYTRUDA is also indicated 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. The NSCLC
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.

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,
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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 United States 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

Merck
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