Interim Data for Merck’s MK-3475, an Investigational Anti-PD-1 Immunotherapy, in Previously Treated Patients with Non-Small

  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

Business Wire

WHITEHOUSE STATION, N.J. -- October 1, 2013

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

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 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 and
connect with us on Twitter, Facebook and YouTube.

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

*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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