Interim Data for Merck’s MK-3475, an Investigational Anti-PD-1 Immunotherapy, in Previously Treated Patients with Non-Small Cell Lung Cancer to be Presented at 15th World Conference on Lung Cancer


October 1, 2013 12:00 pm ET

Merck (NYSE:MRK), known as MSD outside the United States and Canada,
confirmed today that interim data from the company’s Phase IB expansion
study (PN 001) evaluating the efficacy and safety of *MK-3475 in
patients with refractory non-small cell lung cancer (NSCLC) is scheduled
for presentation at the 15th
World Conference on Lung Cancer
on Oct. 29 at 4:15 p.m., (1:15 a.m.
EDT), in Sydney, Australia.

An abstract (# 2416) published today summarized preliminary findings
from 38 patients with NSCLC treated with MK-3475. Data from additional
patients and an analysis of tumor PD-L1 expression is scheduled to be
presented by Dr. Edward Garon, Director of Thoracic Oncology, Jonsson
Comprehensive Cancer Center, University of California, Los Angeles,
during the conference.

“These early data in lung cancer patients were the basis for Merck’s
decision to rapidly advance MK-3475 into a Phase II/III clinical trial
in NSCLC,” said Dr. Eric H. Rubin, vice president, Oncology, Merck
Research Laboratories. “We look forward to further discussion of the
data following its presentation at the conference.”

The published abstract describes early data for 38 patients with NSCLC
treated with MK-3475 as a single agent dosed at 10mg/kg every three
weeks. The preliminary objective response rate (confirmed and
unconfirmed) was 24 percent as measured using investigator-assessed
immune related response criteria (irRC) and 21 percent, (confirmed and
unconfirmed), by RECIST v1.1. The most common treatment-related adverse
events observed were fatigue, rash, and pruritus (16 percent each);
diarrhea grade 1 or 2 occurred in 13 percent of patients. One case of a
drug-related grade 3 pulmonary edema was reported.

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 seven clinical trials estimated to
enroll over 3,000 patients across a broad range of cancer types
including: bladder, colorectal, head and neck, melanoma, non-small cell
lung and triple negative breast. The expansion of 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 over 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

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
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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
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Risks and uncertainties include but are not limited to, general industry
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including obtaining regulatory approval; Merck’s ability to accurately
predict future market conditions; manufacturing difficulties or delays;
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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 (

*A new nonproprietary generic name for MK-3475 is under review by the
United States Adopted Names Council.

Caroline Lappetito, 267-305-7639
Claire Mulhearn, 908-423-7425
Carol Ferguson, 908-423-4465
Justin Holko, 908-423-5088

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