Merck Serono Announces CHMP Positive Opinion to Update Erbitux Metastatic Colorectal Cancer Labeling to Patients with RAS Wild-type Tumors

Darmstadt, Germany (ots/PRNewswire) -

- CHMP recommendation comes in response to new biomarker data obtained from
the OPUS study

Merck Serono, the biopharmaceutical division of Merck, today
announced that the European Medicines Agency's (EMA) Committee for
Medicinal Products for Human Use (CHMP) has issued a positive opinion
on a variation to the Erbitux(R) (cetuximab) product information,
updating the assessment of benefit-risk in patients with metastatic
colorectal cancer (mCRC). The CHMP has recommended the approval of
the indication for Erbitux in the treatment of patients with RAS
wild-type mCRC, based on the totality of data emerging on the role of
mCRC RAS tumor status in the benefit-risk profile of the drug. The
recommendation primarily refers to new biomarker data from the OPUS
study.[1]

In recent analyses of studies evaluating monoclonal anti-EGFR
antibodies such as Erbitux, tumor samples of patients with KRAS
wild-type tumor status (exon 2) were assessed for additional RAS
mutations (defined as mutations in exons 3 or 4 of KRAS and/or exons
2, 3 or 4 of NRAS). The results from these studies indicate that
patients with RAS wild-type tumors may benefit from treatment with
Erbitux, while patients with RAS mutant tumors may not.

"We are pleased with this important evolution of the label for
Erbitux based upon new emerging data from our previous and ongoing
studies of patients living with colorectal cancer," said Dr. Annalisa
Jenkins, Head of Global Research and Development for Merck Serono.
"As the molecular basis and understanding of disease evolves we are
committed to embracing the principles of patient-centric drug
development and personalized medicine."

Based on the CHMP's recommendation and pending agreement of the
European Commission, Erbitux will be indicated for the treatment of
patients with epidermal growth factor receptor-expressing, RAS
wild-type mCRC in combination with irinotecan-based chemotherapy, in
1st line in combination with FOLFOX, or as a single agent in patients
who have failed oxaliplatin- and irinotecan-based therapy and who are
intolerant to irinotecan. In this label change, the combination of
Erbitux with oxaliplatin-containing chemotherapy would be
contraindicated for patients with mutant RAS mCRC or for whom RAS
mCRC status is unknown.

About the OPUS Study

OPUS (OxaliPlatin and cetUximab in firSt-line treatment of mCRC)
is a randomized, controlled, Phase II trial, involving 337 mCRC
patients, 179 with KRAS wild-type (exon 2) tumors, demonstrating the
efficacy of Erbitux plus FOLFOX-4 (oxaliplatin-based therapy) versus
FOLFOX-4 alone.[2] Results of a RAS tumor status analysis have been
submitted for presentation at Gastrointestinal Cancers Symposium
(ASCO GI) 2014.

About Colorectal Cancer

Colorectal cancer (CRC) is the fourth most common cancer
worldwide, with an estimated incidence of more than 1.2 million cases
globally.[3] An estimated 608,000 deaths from CRC occur worldwide
each year, accounting for 8% of all cancer deaths and making it the
fourth most common cause of death from cancer.[3] Almost 60% of the
cases occur in developed regions, and incidence and mortality rates
are substantially higher in men than in women.[3] In Europe alone, an
estimated 436,000 people develop CRC every year, with approximately
212,000 people dying from the disease annually.[4]

References

1) Tejpar S et al. Submitted to 2014 Gastrointestinal Cancers Symposium,
January 16-18, 2014.
2) Bokemeyer C, et al. Ann Oncol 2011;22(7):1535-46.
3) Ferlay J, et al. Int J Cancer 2010;127(12):2893-917.
4) Ferlay J, et al. Eu J Cancer 2010;46(4):765-81.

For more information on Erbitux in colorectal and head & neck
cancer, please visit: http://www.globalcancernews.com.

About Erbitux

Erbitux(R) is a first-in-class and highly active IgG1 monoclonal
antibody targeting the epidermal growth factor receptor (EGFR). As a
monoclonal antibody, the mode of action of Erbitux is distinct from
standard non-selective chemotherapy treatments in that it
specifically targets and binds to the EGFR. This binding inhibits the
activation of the receptor and the subsequent signal-transduction
pathway, which results in reducing both the invasion of normal
tissues by tumor cells and the spread of tumors to new sites. It is
also believed to inhibit the ability of tumor cells to repair the
damage caused by chemotherapy and radiotherapy and to inhibit the
formation of new blood vessels inside tumors, which appears to lead
to an overall suppression of tumor growth.

The most commonly reported side effect with Erbitux is an
acne-like skin rash that seems to be correlated with a good response
to therapy. In approximately 5% of patients, hypersensitivity
reactions may occur during treatment with Erbitux; about half of
these reactions are severe.

Erbitux has already obtained market authorization in 93 countries.
It has been approved for the treatment of colorectal cancer in 93
countries and for the treatment of squamous cell carcinoma of the
head and neck (SCCHN) in 91 countries.

Merck licensed the right to market Erbitux outside the US and
Canada from ImClone LLC, a wholly-owned subsidiary of Eli Lilly and
Company, in 1998. In Japan, ImClone, Bristol-Myers Squibb Company and
Merck jointly develop and commercialize Erbitux. Merck has an ongoing
commitment to the advancement of oncology treatment and is currently
investigating novel therapies in highly targeted areas.

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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approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was
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ots Originaltext: Merck Serono GmbH
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Contact:
Dr. Raphaela Farrenkopf, Phone +49-(0)6151-72-2274,
raphaela.farrenkopf@merckgroup.com