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Home / International News / Press Releases / 2010 / October / October 11, 2010
Surveys Highlight Advancing Confidence in Erbitux as Only Targeted Treatment to Increase Survival and Potential for Cure in Head and Neck Cancer
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Surveys Highlight Advancing Confidence in Erbitux as Only Targeted Treatment to Increase Survival and Potential for Cure in Head and Neck Cancer

Milan, Italy and Darmstadt, Germany

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced results from two surveys which further support the revolutionary role Erbitux® (cetuximab) continues to have in the treatment of head and neck cancer. Data from two key surveys, presented at the 35th Congress of the European Society for Medical Oncology (ESMO) in Milan, show that Erbitux is a standard of care and preferred partner in both LA SCCHN1 and 1st line R/M SCCHN.2

“Erbitux has been valuable in advancing the treatment of head and neck cancer by enhancing symptom relief and extending life in the metastatic setting, and even providing some locally advanced patients with a chance for cure,” said Professor Jean-Louis Lefebvre, Chairman of the European Head and Neck Cancer Society (EHNS) and survey co-investigator.

Survey results in 1st line recurrent and/or metastatic SCCHN

The results from the patient-record-based survey of 256 specialists in France, Germany, Italy and Spain in the R/M setting showed that, in 2009, an Erbitux-based treatment combination was used to treat almost 60% of cases of R/M SCCHN in the 1st line setting.2 These findings reflect the impact of the pivotal Phase III EXTREME trial on everyday clinical practice. EXTREME, published in 2008, demonstrated the first significant improvement in overall survival in SCCHN in 30 years3 and Erbitux remains the only targeted therapy to offer this benefit in 1st line R/M SCCHN.

Survey results in locally advanced SCCHN

A similar survey of patient records conducted in the LA SCCHN setting, revealed:1

“These new findings clearly show that more and more physicians are convinced by the data for Erbitux in the treatment of SCCHN and are changing the way they treat the disease. Erbitux’s position as one of the most significant innovations in this disease in over 30 years is now unquestionable,” said Dr. Wolfgang Wein, Executive Vice President for Oncology at Merck Serono.

Other news from Merck Serono at ESMO 2010

Please visit www.globalcancernews.com for further news about Erbitux from ESMO 2010, including:

References

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 80 countries. It has been approved for the treatment of colorectal cancer in 80 countries and for the treatment of squamous cell carcinoma of the head and neck (SCCHN) in 77 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, 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 potential cancer treatments the use of Stimuvax® (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 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 more than 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.

About Merck

Merck is a global pharmaceutical and chemical company with total revenues of 7.7 billion in 2009, a history that began in 1668, and a future shaped by approximately 40,000 (including Merck Millipore) employees in 64 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

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

1 Budach V, et al. ESMO Congress 2010. Abstract No: 1031P.

2 Wilke H, et al. ESMO Congress 2010. Abstract No: 1033P.

3 Vermorken JB, et al. N Engl J Med 2008;359:1116-27.

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Source:Business Wire (Business Wire India)

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