Merck Serono Announces Initiation of Phase III START2 Study with Tecemotide in Stage III Non-Small Cell Lung Cancer

Darmstadt, Germany (ots/PRNewswire) -

- First patient dosed in tecemotide Phase III trial; study recruiting across
250 sites in over 20 countries
- START2 builds upon the data from the START* trial and explores the potential
of tecemotide in patients with Stage III NSCLC who have demonstrated stable disease or
objective response after concurrent chemoradiotherapy

Merck Serono, the biopharmaceutical division of Merck, today
announced the initiation of the international Phase III START2 study,
which is designed to assess the efficacy and safety of its
investigational MUC1 antigen-specific cancer immunotherapy tecemotide
(also known as L-BLP25) in patients with unresectable, locally
advanced Stage III non-small cell lung cancer (NSCLC).

The START2 study is a Phase III, multicenter, 1:1 randomized,
double-blind, placebo-controlled clinical trial designed to assess
the efficacy, safety and tolerability of tecemotide in patients
suffering from unresectable, locally advanced (Stage IIIA or IIIB)
NSCLC who have had a response or stable disease after at least two
cycles of platinum-based concurrent chemoradiotherapy (CRT).
Concurrent CRT - a combination of chemotherapy and radiotherapy given
at the same time - is the current standard of care for most of these
patients. The study is expected to recruit about 1,000 patients. The
study's primary endpoint is overall survival (OS). Secondary
endpoints include time to symptom progression, progression-free
survival and time to progression. Merck received Scientific Advice
from the European Medicines Agency (EMA) on the program, and reached
an agreement with the U.S. Food and Drug Administration (FDA) on a
Special Protocol Assessment (SPA) for the trial.

"Sadly, the cure rate for stage III NSCLC has not improved in
recent years; novel treatment strategies are urgently needed," said
Professor Suresh Ramalingam, Winship Cancer Institute, Emory
University, Atlanta, U.S., coordinating clinical investigator of the
START2 trial and member of the corresponding steering committee.
"Modulating the immune system to treat cancer has entered an exciting
new phase in the past 2 to 3 years. We hope that the START2 trial
will establish tecemotide as a new treatment option for patients with
NSCLC."

The basis for the new Phase III trial is the outcome of the
initial START study.[1] START did not meet the primary endpoint of
demonstrating an improved OS with tecemotide compared with placebo in
the overall patient population (n=1,239). Median OS was 25.6 months
for patients in the tecemotide group compared with 22.3 months for
those in the placebo group (adjusted hazard ratio [HR]: 0.88; 95%
confidence interval [CI]: 0.75-1.03; p=0.123).

However, data from an exploratory analysis of a pre-defined
subgroup of patients in the START trial, who received tecemotide
after concurrent CRT, showed that these patients achieved a median OS
of 30.8 months versus 20.6 months in patients treated with placebo
(n=806; HR: 0.78; 95% CI: 0.64-0.95; p=0.016).

Dr. John Orloff, Global Head of Clinical Development for Merck
Serono, commented: "There is clearly a very real need for additional
treatment options for people fighting NSCLC. The results of the
initial START study provided scientific and clinical evidence to
inform the design of this new pivotal Phase III program. We are
pleased that START2 is now underway, and feel confident that this
study will address the appropriate gaps in understanding the
potential role that tecemotide could play in the management of
patients living with unresectable stage III NSCLC."

Tecemotide is an investigational MUC1 antigen-specific cancer
immunotherapy designed to stimulate the body's immune system to
identify and target cancer cells expressing the cell-surface
glycoprotein MUC1.[2],[3] MUC1 is expressed in many cancers,
including NSCLC, and has multiple roles in tumor growth and
survival.[2],[4]

Globally, lung cancer is the most common cause of cancer-related
deaths in men and the third most common in women, responsible for
almost twice as many deaths as both breast and prostate cancer
combined.[5] NSCLC is the most common type of lung cancer, accounting
for 80-85% of all lung cancers, and locally advanced or Stage III
disease accounts for approximately 30% of patients with NSCLC.[6],[7]
Unfortunately, at diagnosis, most patients have advanced disease with
a very poor prognosis.[8]

*START: Stimulating Targeted Antigenic Responses To NSCLC

References

1) Butts C, et al. Lancet Oncol 2014;15(1):59-68.
2) Agrawal B, et al. Int Immunol 1998;10(12):1907-16.
3) Palmer M, et al. Clin Lung Cancer 2001;3(1):49-57.
4) Sangha R and Butts C. Clin Cancer Res 2007;13:(15 pt 2)4652s-4654s.
5) Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M,
Parkin DM, Forman D, Bray, F. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality
Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for
Research on Cancer; 2013. Available from: http://globocan.iarc.fr, accessed on
February 5, 2014.
6) D'Addario G, et al. Ann Oncol 2008;19 (suppl 2):ii39-40.
7) Crino L, et al. Ann Oncol 2010;21 (suppl 5):v103-v115.
8) Bunn PA and Thatcher N. Oncologist 2008;13 (suppl 1):1-4.

About tecemotide

Tecemotide is an investigational MUC1 antigen-specific cancer
immunotherapy that is designed to stimulate the body's immune system
to identify and target cells expressing the cell-surface glycoprotein
MUC1. MUC1 is expressed in many cancers, including non-small cell
lung cancer (NSCLC), and has multiple roles in tumor growth and
survival. Tecemotide is currently being investigated in the Phase III
START2, START and INSPIRE trials for the treatment of unresectable,
locally advanced Stage III NSCLC.

Merck obtained the exclusive worldwide rights for development and
commercialization of tecemotide from Oncothyreon Inc., Seattle,
Washington, U.S., in 2007, in an agreement replacing prior
collaboration and supply agreements originally entered in 2001. In
Japan, Merck entered into a co-development and co-marketing agreement
for tecemotide with Ono Pharmaceutical Co., Ltd., Osaka, Japan.

The START2 trial is a Phase III, multicenter, 1:1 randomized,
double-blind, placebo-controlled clinical trial designed to assess
the efficacy, safety and tolerability of tecemotide in patients
suffering from unresectable, locally advanced (Stage IIIA or IIIB)
NSCLC who have had a response or stable disease after at least two
cycles of platinum-based concurrent chemoradiotherapy (CRT). The
primary endpoint of START2 trial is overall survival.

The initial Phase III trial START is a multicenter, randomized,
double-blind, placebo-controlled clinical trial designed to assess
the efficacy, safety and tolerability of tecemotide in patients
suffering from unresectable, locally advanced (Stage IIIA or IIIB)
NSCLC who have had a response or stable disease after at least two
cycles of platinum-based chemoradiotherapy (concurrent or
sequential). The trial involves 1,239 patients in 33 countries. The
primary endpoint of overall survival was not met in the START trial.

INSPIRE (tecemotide liposome vaccine trial In Asian NSCLC
Patients: Stimulating Immune REsponse) is a Phase III, multicenter,
randomized, double-blind, placebo-controlled clinical trial designed
to evaluate the efficacy, safety and tolerability of tecemotide in
patients suffering from unresectable, locally advanced Stage IIIA or
IIIB NSCLC who have had a response or stable disease after at least
two cycles of platinum-based concurrent chemoradiotherapy. INSPIRE is
recruiting approximately 500 unresectable, locally advanced Stage III
NSCLC patients across China, Hong Kong, Korea, Singapore and Taiwan.

Tecemotide is currently under clinical investigation and has not
been approved for use in the U.S., Europe, Canada, or elsewhere.
Tecemotide has not been proven to be either safe or effective and any
claims of safety and effectiveness can be made only after regulatory
review of the data and approval of the labeled claims.

About Merck Serono

Merck Serono is the biopharmaceutical division of Merck. With
headquarters in Darmstadt, Germany, Merck Serono offers leading
brands in 150 countries to help patients with cancer, multiple
sclerosis, infertility, endocrine and metabolic disorders as well as
cardiovascular diseases. In the United States and Canada, EMD Serono
operates as a separately incorporated subsidiary of Merck Serono.

Merck Serono discovers, develops, manufactures and markets
prescription medicines of both chemical and biological origin in
specialist indications. We have an enduring commitment to deliver
novel therapies in our core focus areas of neurology, oncology,
immuno-oncology and immunology.

For more information, please visit http://www.merckserono.com.

All Merck Press Releases are distributed by e-mail at the same
time they become available on the Merck Website. Please go to
http://www.merckgroup.com/subscribe to register online, change your
selection or discontinue this service.

Merck is a leading company for innovative and top-quality
high-tech products in the pharmaceutical and chemical sectors. With
its four divisions Merck Serono, Consumer Health, Performance
Materials and Merck Millipore, Merck generated total revenues of EUR
11.1 billion in 2013. Around 38,000 Merck employees work in 66
countries to improve the quality of life for patients, to further the
success of our customers and to help meet global challenges.

Merck is the world's oldest pharmaceutical company - since 1668,
the company has stood for innovation, business success and
responsible entrepreneurship. Holding an approximately 70% interest,
the founding family remains the majority owner of the company to this
day.

Merck, Darmstadt, Germany is holding the global rights to the
Merck name and brand. The only exceptions are Canada and the United
States, where the company is known as EMD.

ots Originaltext: Merck Serono GmbH
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Merck KGaA, Frankfurter Strasse 250, 64293 Darmstadt, Germany.
Hotline +49-(0)6151-72-5000. Your Contact: Dr Cornelia Bartels, Phone
+49-(0)6151-72-3890, Email cornelia.bartels@merckgroup.com.