Merck Serono to Present New Data at ECCO/ESMO Oncology Congress Showcasing Leadership in Personalized Cancer Care

A total of 17 Abstracts accepted for Presentation at the Leading European Oncology Congress

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, continues to drive the global effort to ensure patients receive personalized cancer therapies. A total of 17 abstracts concerning Merck Serono oncology treatments will be presented at the joint 15th Congress of the European Cancer Organisation (ECCO) and 34th Congress of the European Society for Medical Oncology (ESMO), to be held in Berlin from 20-24 September 2009.

At the meeting, Merck Serono, its partners and independent researchers will be presenting new data on Erbitux® (cetuximab) from the major COINa, CRYSTALb and OPUSc studies in metastatic colorectal cancer (mCRC), as well as the results of a meta-analysis of four trials of Erbitux in non-small cell lung cancer (NSCLC). In addition, Erbitux data involving potential new disease areas and novel combination therapy regimens will be presented.

Elmar Schnee, member of the Merck Executive Board and President of the Merck Serono division, explains: “Erbitux has broken the barrier between targeted therapies and personalized cancer care in colorectal cancer. The modern understanding of cancer biology has shifted oncology treatment from one-size fits all to an adapted and therefore more responsible approach to cancer care.”

Colorectal cancer (CRC)
The independent COIN study1 is the largest (n=1,630) independent study to date to investigate the impact of adding Erbitux to chemotherapy for the 1st-line treatment of mCRC and results due to be presented at the ECCO/ESMO congress will add to our understanding of the benefit of personalized therapies in the treatment of this aggressive disease.
A meta-analysis of the CRYSTAL and OPUS studies,2 combining Erbitux with chemotherapy as 1st-line treatment for patients with mCRC, with results according to KRAS status, is expected to reinforce the key role of clinical biomarkers in this indication.
Final results from a Spanish Phase II study of Erbitux in combination with capecitabine in the 1st-line treatment of elderly patients with advanced CRC will be also be presented.3

Non-small cell lung cancer (NSCLC)
A meta-analysis of four key studies of Erbitux in NSCLC – looking at the key endpoints of overall survival and progression-free survival – will be presented for the first time at a European congress.4

Squamous cell carcinoma of the head and neck (SCCHN)
Merck Serono will be presenting preliminary data from the Phase I/II ADVANTAGE trial for cilengitide, an integrin inhibitor, in a study assessing the potential utility of this investigational targeted anti-cancer agent in SCCHN.5

Gastric and rectal cancers
Data from an ongoing Phase II study investigating the potential of Erbitux in combination with an irinotecan-based regimen as a 1st-line treatment for advanced gastric cancer will be presented,6 as well as a study that used Erbitux as a neoadjuvant therapy in locally advanced resectable rectal cancer when combined with capecitabine and radiotherapy (RT).7

Dr. Wolfgang Wein, Executive Vice President, Oncology, Merck Serono concluded: “Combination really is key in oncology and these studies are tangible results based on our strategic imperative to advance targeted therapies to the next level of personalized cancer care. We are continuing to explore multiple combination therapies that enable physicians to choose the best treatment regimens based on patient need.”

aCOIN: A Phase III trial comparing either COntinuous chemotherapy plus cetuximab or INtermittent chemotherapy with standard continuous palliative combination chemotherapy with oxaliplatin and a fluoropyrimidine in first line treatment of metastatic colorectal cancer

bCRYSTAL: Cetuximab combined with iRinotecan in first line therapY for metaSTatic colorectAL cancer

cOPUS: OxaliPlatin and cetUximab in firSt-line treatment of mCRC

References

1. Maughan TS, et al. ECCO/ESMO Congress 2009; Abstract No: 6LBA.
2. Van Cutsem E, et al. ECCO/ESMO Congress 2009; Abstract No: 6077.
3. Rivera F, et al. ECCO/ESMO Congress 2009; Abstract No: 4004.
4. Pujol J, et al. ECCO/ESMO Congress 2009; Abstract No: 9009.
5. Brümmendorf T, et al. ECCO/ESMO Congress 2009; Abstract No: 8517.
6. Möhler M, et al. ECCO/ESMO Congress 2009; Abstract No: 6579.
7. Velenik V, et al. ECCO/ESMO Congress 2009; Abstract No: 6019.

For more information on Erbitux in colorectal, head & neck and non-small cell lung cancer, please visit: www.globalcancernews.com.

About Erbitux
Erbitux® 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 78 countries. It has been approved for the treatment of colorectal cancer in 78 countries and for the treatment of squamous cell carcinoma of the head and neck (SCCHN) in 72 countries:
December 2003 (Switzerland), February 2004 (USA), June 2004 (EU) and followed by other countries: for use in combination with irinotecan in patients with EGFR-expressing mCRC (metastatic colorectal cancer) who have failed prior irinotecan therapy. In addition, Erbitux is also approved for single-agent use in further countries.
April 2006 (EU) and followed by other countries: for use in combination with radiotherapy for the treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN). In further countries, Erbitux is also approved as monotherapy in patients with recurrent and/or metastatic SCCHN who failed prior chemotherapy.
July 2008 (EU): license was updated for the treatment of patients with epidermal growth factor receptor (EGFR) expressing, KRAS wild-type mCRC in combination with chemotherapy and as a single agent in patients who have failed oxaliplatin-and irinotecan-based therapy and who are intolerant to irinotecan.
July 2008 (Japan): for use in combination with irinotecan in patients with EGFR-expressing mCRC who have failed prior irinotecan therapy
In November 2008 (EU): license was updated for the use in combination with platinum-based chemotherapy in patients with recurrent and/or metastatic SCCHN

Merck licensed the right to market Erbitux outside the US and Canada from ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company, in 1998. In Japan, ImClone Systems, 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, such as the use of Erbitux in colorectal cancer, squamous cell carcinoma of the head and neck and non-small cell lung cancer. Merck has also acquired the rights for the cancer treatment UFT® (tegafur-uracil) – an oral chemotherapy administered with folinic acid (FA) for the first-line treatment of metastatic colorectal cancer.

Merck is also investigating among other cancer treatments the use of Stimuvax® (formerly referred to as BLP25 Liposome Vaccine) in the treatment of non-small cell lung cancer. The vaccine was granted fast-track status in September 2004 by the FDA. Merck obtained the exclusive worldwide licensing rights from Oncothyreon Inc., Seattle, Washington, USA.

In addition, Merck is developing cilengitide, which is the first in a new class of investigational anti-cancer therapies called integrin inhibitors to reach Phase III of development; it is currently being investigated for the treatment of glioblastoma, SCCHN and NSCLC. Integrin inhibitors are thought to work by targeting the tumor and its vasculature.

About Merck Serono
Merck Serono is the division for innovative prescription pharmaceuticals of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical company. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. In the United States and Canada, EMD Serono operates through separately incorporated affiliates.

Merck Serono has leading brands serving patients with cancer (Erbitux®, cetuximab), multiple sclerosis (Rebif®, interferon beta-1a), infertility (Gonal-f®, follitropin alpha), endocrine and metabolic disorders (Saizen® and Serostim®, somatropin), (Kuvan®, sapropterin dihydrochloride) as well as cardiometabolic diseases (Glucophage®, metformin), Concor®, bisoprolol), (Euthyrox®, levothyroxine). Not all products are available in all markets.

With an annual R&D expenditure of around € 1bn, Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in autoimmune and inflammatory diseases.

For more information, please visit www.merckserono.com or www.merck.de

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