Merck Serono Announces New Publication of Results of the Phase III START Trial Investigating Tecemotide in Non-Small Cell Lung Cancer in The Lancet Oncology

Darmstadt, Germany (ots/PRNewswire) -

- Publication offers detailed results of START, including an exploratory
analysis of the clinically meaningful survival prolongation with tecemotide
maintenance therapy in a predefined subgroup of patients treated with concurrent
chemoradiotherapy
- As previously announced Merck Serono will continue the development of
tecemotide in non-small cell lung cancer based on the results of this subgroup
analysis

Merck Serono, the biopharmaceutical division of Merck, today
announced that The Lancet Oncology has published results from the
Phase III trial 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), known as the START* trial.

Data included in the publication[1], and first presented at the
American Society of Clinical Oncology (ASCO) 2013[2], showed that the
primary endpoint of overall survival (OS) was not met. Median OS was
25.6 months for patients in the tecemotide group compared with 22.3
months for those in the placebo group (adjusted HR: 0.88, 95% CI
0.75-1.03, p=0.123). The publication includes an exploratory analysis
of a predefined subgroup of patients in the START trial who received
tecemotide after concurrent chemoradiotherapy (CRT).[1] Concurrent
CRT is a combination of chemotherapy and radiotherapy given at the
same time. Patients in this subgroup achieved a median OS of 30.8
months vs. 20.6 months in patients treated with placebo (n=806; HR:
0.78; 95% CI 0.64-0.95; p=0.016).[1] In patients receiving sequential
CRT followed by tecemotide or placebo a median OS of 19.4 months was
observed for the tecemotide group compared with 24.6 months for the
placebo group (n=433; HR 1.12; 95% CI 0.87-1.44; p=0.38).

"These results have generated considerable interest within the
scientific community and we hope that the publication will provide
additional context to help inform future immuno-oncology research,"
said Dr. Charles Butts, Cross Cancer Institute, University of
Alberta, Edmonton, Canada, clinical investigator of the START trial
and member of the corresponding steering committee. "In the article
we have hypothesized potential reasons why the combination with
concurrent CRT demonstrated increased overall survival in START
compared to combination with sequential CRT and we look forward to
investigating tecemotide further to determine if it is a suitable
therapeutic option that could help deliver positive outcomes for
patients."

As previously announced, Merck Serono will continue the
development of tecemotide under a new Phase III trial called START2,
based on the results of the START trial. The START2 trial is a
multicenter, randomized, double-blind, placebo-controlled 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 CRT.
Concurrent CRT is the standard of care for these patients. The
trial's primary endpoint is OS. Merck has received Scientific Advice
from the European Medicines Agency (EMA) on the program, and has
reached an agreement with the U.S. Food and Drug Administration (FDA)
on a Special Protocol Assessment (SPA) for the Phase III
international randomized trial.

Dr. Annalisa Jenkins, Head of Global Head of Global Research and
Development for Merck Serono, said: "The publication of the START
trial confirms the interest of the scientific medical community in
the potential that immunotherapy may offer for patients living with
lung cancer. We continue to pursue development of tecemotide in the
hope that it can potentially bring meaningful benefit for patients
fighting this devastating disease."

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.[3],[4] MUC1 is expressed in many cancers,
including NSCLC, and has multiple roles in tumor growth and
survival.[3],[5]

Globally, lung cancer is the most common cause of cancer-related
deaths in men and the second most common in women, responsible for
almost twice as many deaths as both breast and prostate cancer
combined.[6] 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.[7],[8]
Unfortunately, at diagnosis, most patients have advanced or
metastatic disease with a very poor prognosis.[9] There is an
especially urgent and ongoing need for new approaches for patients
with advanced, unresectable NSCLC.

[*] START: Stimulating Targeted Antigenic Responses To NSCLC

References

1) Butts C, et al. The Lancet Oncology 2013. Available at:
http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(13)70510-2/fulltext
. Last accessed on December 9, 2013.
2) Shepherd F, et al. Poster discussion session at the European Cancer Congress
2013, September 29. Abstract No:3419.
3) Agrawal B, et al. Int Immunol 1998;10(12):1907-16.
4) Palmer M, et al. Clin Lung Cancer 2001;3(1):49-57.
5) Sangha R and Butts C. Clin Cancer Res 2007;13:(15 pt 2)4652s-4654s.
6) Ferlay J, Shin HR, Bray F, Forman D, Mathers C and Parkin DM. GLOBOCAN 2008
v2.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 10 [Internet].
Lyon, France: International Agency for Research on Cancer; 2010. Available at:
http://globocan.iarc.fr. Last accessed on March 11, 2013.
7) D'Addario G, et al. Ann Oncol 2008;19 (suppl 2):ii39-40.
8) Crino L, et al. Ann Oncol 2010;21(suppl 5):v103-v115.
9) Bunn PA, et al. 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
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, 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. The design
of INSPIRE is almost identical to the START trial, however, due to
the results of START, only subjects who have received concurrent CRT
are being entered into INSPIRE. INSPIRE is enrolling approximately
420 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.

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that began in 1668, and a future shaped by approx. 38,000 employees
in 66 countries. Its success is characterized by innovations from
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