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October 29, 2013 1:15 am ET

Phase II/III Trial of MK-3475 in Patients with NSCLC Currently Enrolling

Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced the presentation of interim data from a Phase 1B trial
(PN001) evaluating MK-3475, an investigational anti-PD-1 immunotherapy,
in patients with previously-treated non-small cell lung cancer (NSCLC).
The data were presented today by Dr. Edward Garon, Director of Thoracic
Oncology, Jonsson Comprehensive Cancer Center, University of California,
Los Angeles, at the 15th
World Conference on Lung Cancer in Sydney, Australia (Abstract #
MO18.02).

Detailed interim data were presented for response rates and safety from
a cohort of 38 previously-treated NSCLC patients who received MK-3475
10mg/kg every three weeks as well as initial findings from an analysis
of the relationship between response rates and PD-L1 expression.

“We are encouraged by these initial responses in NSCLC patients,” said
Dr. Eric H. Rubin, vice president, Oncology, Merck Research
Laboratories. “Based on these preliminary data and other research, we
believe that PD-L1 expression has the potential to be a useful predictor
of response to MK-3475 in certain cancers. We look forward to further
data from this and other studies to help us to understand the potential
role of MK-3475 in lung cancer, and of PD-L1 as a biomarker.”

Based on data from this Phase IB study, Merck initiated a Phase II/III
trial comparing two doses of MK-3475, 10mg/kg every three weeks and
2mg/kg every three weeks (10mg/kg Q3W and 2mg/kg Q3W), versus docetaxel
in previously-treated patients with NSCLC who have received at least one
prior treatment regimen (see clinicaltrials.gov).
Merck plans to present data from ongoing studies evaluating 10mg/kgQ2W
and 10mg/kgQ3W dosing regimens for MK-3475 in patients with NSCLC in
2014.

Interim results presented at International Association for Study of
Lung Cancer 2013

Tumor responses were assessed by investigator-assessed, immune-related
response (irRC) criteria as well as independent, central, blinded
radiographic review per Response Evaluation Criteria in Solid Tumors
(RECIST 1.1) criteria.

In the 38-patient cohort, the objective response rate in patients
receiving MK-3475 was 24 percent based on irRC, and 21 percent based on
RECIST (n=33). The median overall survival at time of analysis was 51
weeks with seven of the nine responders, determined by irRC, continuing
on treatment. The median response duration has not been reached at the
time of this analysis. Detailed results as presented are shown below:

Interim efficacy data for MK-3475 (10mg/kg Q3W) in previously treated
patients with advanced NSCLC

NR=Not Reached; OS= Overall Survival; PFS= Progression-Free Survival
¹Objective
response rate (ORR) = confirmed complete (CR) and partial response (PR)
^*Response
rate per RECIST v1.1 is based on those patients who had ≥1 measurable
lesion at baseline per central review. All responses were confirmed
except for 2. One patient withdrew consent for treatment, unrelated to
toxicity, after the first imaging assessment, and 1 patient had a
confirmatory scan of PR at day 27.

The most commonly reported drug-related adverse events in the study,
(all grades), were: rash (21%), pruritus (18%), fatigue (16%), diarrhea
(13%) and arthralgia (11%). The majority of adverse events were low
grade (grade 1-2) there was one incident of grade 3 pulmonary edema.

An analysis of the relationship between PD-L1 expression status and
response rates in this NSCLC patient cohort was also presented. Tumor
samples were analyzed and classified as expressing either zero/low or
high levels of PD-L1. High levels of expression according to the assay
criteria, were associated with response rates of 67 percent (6/9) [95%
CI; range 30, 93] per irRC and 57 percent (4/7) [95% CI; range 18, 90]
per RECIST. In comparison, tumor samples expressing zero/low levels of
PD-L1, according to assay criteria, were associated with response rates
of 4 percent (1/24) [95% CI; range 0, 21] per irRC and 9 percent (2/22)
per RECIST [95% CI; range 1, 29]. Data from more patients are needed to
better understand the relationship between PD-L1 expression and response
to MK-3475.

About MK-3475

Many tumors are able to evade the immune system through a mechanism that
exploits the PD-1 inhibitory checkpoint protein. MK-3475 is an
investigational, highly selective anti-PD-1 immunotherapy designed to
restore the natural ability of the immune system to recognize and target
cancer cells by selectively achieving dual ligand blockade (PD-L1 and
PD-L2) of the PD-1 protein. By blocking PD-1, MK-3475 enables activation
of the immune system’s T-cells that target cancer by essentially
releasing a brake on the immune system.

MK-3475 is currently being studied in eight clinical trials estimated to
enroll over 3,000 patients across a broad range of cancer types
including: bladder, colorectal, gastric, head and neck, melanoma,
non-small cell lung, triple negative breast and hematological
malignancies. Additional trials both as monotherapy and in combination
with other cancer therapies are planned. The expansion of the MK-3475
clinical development program is based on preliminary clinical evidence
from Merck’s large foundational Phase IB trial (PN 001) evaluating
MK-3475 monotherapy in more than 1,000 patients with diverse late-stage
cancers (metastatic carcinoma).

About Lung Cancer

Lung cancer is the leading cause of cancer death worldwide in both men
and women, with an estimated 1.4 million deaths worldwide each year,
according to the American Cancer Society. NSCLC is the most common type
of lung cancer representing about 85 percent of all lung cancer
diagnoses.

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
consumer care 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
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Merck 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 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; 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 2012 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).

Merck
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