Merck Discontinues Clinical Development Program of Tecemotide as a Monotherapy in Stage III Non-Small Cell Lung Cancer

Darmstadt, Germany (ots/PRNewswire) -

Not intended for UK-based media

Merck announced today that its biopharmaceutical division Merck
Serono will discontinue the clinical development program of its
investigational MUC1 antigen-specific cancer immunotherapy tecemotide
(also known as L-BLP25) as a monotherapy in Stage III non-small cell
lung cancer (NSCLC).

Luciano Rossetti, Global Head of Research & Development at Merck
Serono, said: "While the data from the exploratory subgroup analysis
in the START trial[1] generated a reasonable hypothesis to warrant
additional study, the results of the recent trial in Japanese
patients decreased the probability of current studies to reach their
goals. Therefore, we have decided to discontinue the development of
tecemotide as a monotherapy in NSCLC in order to refocus our efforts
on other promising candidates in our pipeline, like our anti-PD-L1
antibody MSB0010718C. Merck Serono remains committed to developing
new treatment options for patients with difficult-to-treat cancers."

The company's decision to discontinue the current clinical program
in NSCLC, which includes the Phase III START2 and INSPIRE studies,
follows recent results from a planned analysis of EMR 63325-009, a
randomized, double-blind, placebo-controlled Phase I/II study in
Japanese patients with Stage III unresectable, locally advanced NSCLC
who had received concurrent or sequential chemoradiotherapy (CRT),
with a minimum of two cycles of platinum-based chemotherapy and
radiation dose greater than or equal to50 Gy. Of the patients
included in the Phase II part of the study, the majority had received
concurrent CRT. The results indicate that no effect has been observed
for either the primary endpoint, overall survival (OS), or for any of
the secondary endpoints (progression-free survival [PFS], time to
progression [TTP] and time to treatment failure). An analysis of the
reported adverse events has not identified a clinically meaningful
difference in the frequency between treatment groups. Although the
trial was not powered to demonstrate a statistically significant
difference in benefit between the two arms, Merck Serono made the
recommendation to stop the investigational treatment for patients in
the EMR 63325-009 study in Japan.

Merck Serono has made the decision to discontinue all other Merck
Serono-sponsored clinical trials with tecemotide in NSCLC worldwide.
Those patients on active treatment with tecemotide can undergo an
individual assessment by their treating physician and apply to
receive further treatment outside of the studies. The company will
continue to supply tecemotide for ongoing investigator-sponsored
trials in other indications in accordance with Merck's agreements
with the sponsors of these studies.

Merck Serono continues to evaluate a number of investigational
compounds for difficult-to-treat cancers, and remains committed to
improving the lives of cancer patients and their families.

References

1) Butts C, et al. Lancet Oncol 2014;15(1):59-68.

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 NSCLC, and has
multiple roles in tumor growth and survival. Tecemotide was 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 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 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, which began in April 2014, expected to recruit about 1,000
patients. The study's primary endpoint is OS. Secondary endpoints
include time to symptom progression, PFS and TTP.

The basis for the START2 trial was the outcome of the initial
START study. 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).

INSPIRE 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 CRT. INSPIRE expected to recruit
approximately 500 Stage III NSCLC patients across China, Hong Kong,
Korea, Singapore and Taiwan.

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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 39,000 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 and chemical 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 KGaA
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