What can we help you find?

June 2, 2013 10:15 am ET

Merck Expands Lambrolizumab Clinical Development Program-

Study Published Online in the New England Journal of Medicine-

Merck (NYSE: MRK), known as MSD outside the United States and Canada,
today announced the presentation of preliminary results from an ongoing
Phase IB expansion study evaluating the safety and efficacy of
lambrolizumab (MK-3475), Merck’s investigational antibody therapy
targeting PD-1, in patients with advanced (inoperable and metastatic)
melanoma. The data were presented by Antoni Ribas, M.D., Ph.D.,
professor, Hematology/Oncology and Surgery, and director of the Tumor
Immunology Program at the Jonsson Comprehensive Cancer Center,
University of California, Los Angeles, during an oral session at the
American Society of Clinical Oncology (ASCO) 2013 Annual Meeting in
Chicago (Abstract# 9009). The study was also published online in the New
England Journal of Medicine.

“We are encouraged by the results observed to date, including the rate
and duration of responses, in patients with advanced melanoma,” said
Roger M. Perlmutter, M.D. Ph.D., president, Merck Research Laboratories.
“Based on these data and additional findings from our ongoing studies,
Merck plans to initiate late-stage clinical trials of lambrolizumab in
advanced melanoma, and non-small cell lung cancer in the third quarter
of 2013.”

Data from the ongoing multi-center, single-arm open-label Phase IB trial
were presented from 135 patients with advanced melanoma enrolled in the
study and who were administered an initial dose of lambrolizumab between
Dec. 1, 2011, and Sept. 6, 2012. Patients received one of three dosing
regimens of lambrolizumab (10mg/kg every two weeks [10mg/kg Q2W];
10mg/kg every three weeks [10mg/kg Q3W] or 2mg/kg every three weeks
[2mg/kg Q3W]) until disease progression or unacceptable toxicity. Tumor
response was assessed every 12 weeks by independent, central, blinded
radiographic review per RECIST 1.1 (Response Evaluation Criteria in
Solid Tumors) criteria as well as investigator-assessed, immune-related
response criteria. Earlier interim data from this study were presented
at the 9th
International Congress of the Society for Melanoma Research (SMR) in
Hollywood, Calif., in November 2012.

Objective response rates for lambrolizumab in patients with advanced
melanoma

The interim overall confirmed response rate for lambrolizumab treatment
was 38 percent (range 25–44 percent), as measured by RECIST 1.1
independent review across all dosing regimens evaluated. The highest
overall response rate observed was 52 percent, which occurred in the 10
mg/kg Q2W dosing regimen. Ten percent of patients in this dose group
were complete responders. The duration of confirmed responses, as
measured after the first 12 week evaluation, ranged from greater than 28
days to up to more than 8 months at the time of the analysis, with 80
percent of responding patients continuing on treatment. The median
duration of response has not been reached with a median follow-up time
of 11 months. The most common treatment-related adverse events observed
for those patients evaluable for adverse events, as of December 2012,
were mostly grade 1/2 and included fatigue (30%), rash (21%), pruritus
(21%) and diarrhea (20%). Six (4.4%) treatment-related cases of
pneumonitis were reported (all grade 1/2). A total of 17 (13%) grade 3/4
treatment-related adverse events were reported, the most common of these
were fatigue (1.5%), rash (2%) and elevated AST levels (1.5%). The
majority of reported grade 3/4 events occurred in patients administered
10mg/kg Q2W.

The response rates for ipilimumab-pretreated and ipilimumab-naïve
patients treated with lambrolizumab were similar.

“We continue to make significant progress in our clinical development
program for lambrolizumab in multiple indications,” said Gary Gilliland,
M.D., Ph.D., senior vice president and oncology franchise head, Merck
Research Laboratories. “We are very grateful to the patients,
investigators, regulators and the broader oncology community for their
ongoing collaboration and support in advancing this program.”

Lambrolizumab Clinical Development Program

Merck is currently conducting four clinical trials evaluating
lambrolizumab in multiple cancer types that involve more than 600
patients. The company recently initiated a global, randomized, Phase II
clinical trial of lambrolizumab versus standard chemotherapy for
patients with advanced melanoma whose disease has progressed after prior
therapy (ref: NCT01704287)
and a Phase I trial of lambrolizumab for the treatment of triple
negative breast, metastatic bladder cancer and head & neck cancer (ref: NCT01848834).
Further late-stage studies including a Phase III study evaluating
lambrolizumab in ipilimumab-naïve patients with advanced melanoma and a
Phase II/III trial in non-small cell lung cancer (NSCLC) are scheduled
to commence in the third quarter of 2013. Additional trials in several
hematological cancers and evaluation of lambrolizumab-containing
combinations are scheduled to start this year. Merck announced that lambrolizumab
had received Breakthrough Therapy designation from the U.S. Food and
Drug Administration for advanced melanoma in April 2013.

Merck Oncology Briefing Webcast

Merck will hold a briefing on June 2 at 1:00 p.m. CDT to present an
update of ongoing progress in the development of its oncology candidates
MK-1775 and vintafolide, as well as provide details regarding its
clinical development plans for lambrolizumab. Investors and journalists
may access a live audio webcast of the event on Merck’s website at http://www.merck.com/investors/events-and-presentations/home.html.
Software needed to listen to the webcast is available on the corporate
website and should be downloaded prior to the beginning of the webcast.
A replay of the webcast will be available at approximately 8:00 a.m. EDT
on June 3.

About Lambrolizumab

Lambrolizumab is an investigational antibody therapy designed to disrupt
the action of the immune checkpoint protein PD-1 and therefore inhibit
the ability of some cancers to evade the body’s immune system.
Lambrolizumab is being studied in multiple cancer types including
melanoma and non-small cell lung cancer. For further details, please
visit http://clinicaltrials.gov.

About Breakthrough Therapy Designation

The designation of an investigational drug as a Breakthrough Therapy is
intended to expedite the development and review of a candidate that is
planned for use, alone or in combination, to treat a serious or
life-threatening disease or condition when preliminary clinical evidence
indicates that the drug may demonstrate substantial improvement over
existing therapies on one or more clinically significant endpoints. The
Food and Drug Administration Safety and Innovation Act (FDASIA) includes
a provision that allows sponsors to request that an investigational drug
be designated as a Breakthrough Therapy. The implications of
Breakthrough Therapy Designation cannot be determined at this time.

About PD-1

Researchers have shown that several tumor types are able to hide in
plain sight by establishing a “molecular camouflage” that deceives the
body’s immune system into thinking they are normal and therefore allow
them to grow unchecked. The interaction between the immune checkpoint
receptor PD-1 and its ligands represents a potentially important
tumor-specific immunomodulatory mechanism. By utilizing the PD-1
pathway, a tumor cell can prevent the activation of T-cells and
therefore may block a key step that triggers the immune system.

About Advanced Melanoma

Advanced melanoma accounts for more than 80 percent of skin
cancer-related deaths and one to two percent of all cancer deaths in the
United States. According to the American Cancer Society, an estimated
9,180 people in the U.S. died from advanced melanoma in 2012.

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
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 (www.sec.gov).

Merck
Media Contacts:
Ian McConnell, 973-901-5722
Cathy Cantone, 908-327-3013
or
Investor Contacts:
Carol Ferguson, 908-500-1101
Justin Holko, 609-915-8293