Merck Serono Launches Erbitux In 1st-line Treatment Of Head And Neck Cancer In Europe

Main Category: Neurology / Neuroscience
Also Included In: Ear, Nose and Throat;  Cancer / Oncology
Article Date: 26 Jan 2009 - 1:00 PDT

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Today leading oncology specialists and media gathered at the Antwerp University Hospital to mark the European launch of Erbitux® (cetuximab) for the 1st-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN), following European Commission approval to extend the use of the targeted therapy. Erbitux was previously approved for use in combination with radiotherapy for locally advanced SCCHN.

The approval of Erbitux in this new indication was granted in November 2008 and based primarily upon the results of the EXTREMEa study, published in the New England Journal of Medicine in September 2008. The EXTREME study established that adding Erbitux to platinum-based chemotherapy significantly prolonged median overall and progression-free survival, and also significantly increased response rate.1

The principal investigator of the EXTREME trial, Professor Jan Vermorken from the Antwerp University Hospital, a world renowned center of excellence in oncology research and treatment said: "We are pleased to be hosting the international launch of Erbitux in this notoriously difficult to treat cancer type. This is the first treatment regimen in 30 years to show a survival benefit and denotes a significant milestone in the advancement of treatment for head and neck cancer."

The EXTREME study demonstrated that patients treated with Erbitux plus chemotherapy experienced the following improvements, compared to chemotherapy alone:1

- Median overall survival increase of nearly 3 months (10.1 vs. 7.4 months; p=0.04), equating to a 20% reduction in the risk of death (HR: 0.80) during the study period

- 70% relative increase in median progression-free survival (5.6 vs. 3.3 months; p<0.001)

- Almost doubling of response rate (36% vs. 20%; p<0.001)

Concurrent with the launch of Erbitux, preliminary results were released from a new European survey "About Face", which was conducted by the European Head and Neck Society (EHNS) to investigate the awareness of head and neck cancer among the general public. The results showed alarmingly low levels of knowledge about the symptoms, risk factors and body parts affected by the disease2 despite it being the sixth-most common cancer worldwide .3

In Europe alone, it is estimated that there are around 143,000 new cases of head and neck cancer and more than 68,000 deaths due to the disease each year.4 About 40% of patients with head and neck cancer have recurrent and/or metastatic SCCHN.5 Head and neck cancer includes cancers of the tongue, mouth, salivary glands, pharynx, larynx, sinuses and other sites located in the head and neck area. About 90% of head and neck cancers are of the squamous cell variety6 and nearly all express the epidermal growth factor receptor (EGFR) which is critical for tumor growth.7 Erbitux targets the EGFR. Although there have been significant improvements in chemotherapy and surgical techniques, the disease is particularly challenging to treat since most patients present with advanced disease and often have second primary tumors in addition to suffering from other co-morbidities.8 At least 75% of all head and neck cancers are attributed to two major risk factors, smoking and alcohol consumption.9

"We are honored to launch Erbitux in the 1st-line treatment for recurrent and/or metastatic SCCHN at a facility renowned for its pioneering work into head and neck cancer," said Dr Wolfgang Wein, Executive Vice President, Oncology, Merck Serono. "We hope that patients and specialists alike are encouraged by this first significant advance in this treatment setting in 30 years. Today's launch reinforces the impressive potential of Erbitux to extend patients' lives and further confirms the high activity of Erbitux against difficult to treat cancers."

a EXTREME: ErbituX in 1st-line Treatment of REcurrent or MEtastatic head and neck cancer

References

1. Vermorken JB, et al. N Engl J Med 2008;359:1116-27.
2. About Face survey [TNS Healthcare 2008. 'About Face' Head and Neck Cancer Awareness - EU Omnibus Survey
3. Hunter KD,et al. Nat Rev Cancer 2005;Feb;5(2):127-35
4. GLOBOCAN 2002 (www-dep.iarc.fr), accessed November 2008.
5. Lefebvre J-L. Ann Oncol 2005;16(Suppl 6):vi7-vi12.
6. Vermorken J. Ann Oncol 2005;16(Suppl 2):ii258-ii264.
7. Grandis JR & Tweardy DJ. Cancer Res 1993;53(15):3579-84.
8. Forastiere A, et al. N Engl J Med 2001;345(26):1890-1900.
9. Hashibe M, et al. J Natl Inst 2007;99:777-89.

For more information on Erbitux in colorectal, head & neck and non-small cell lung cancer, please visit: http://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 76 countries. It has been approved for the treatment of colorectal cancer in 75 countries so far: Argentina, Australia, Belarus, Canada, Chile, China, Colombia, Costa Rica, Croatia, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Hong Kong, Iceland, India, Indonesia, Israel, Japan, Kazakhstan, Kuwait, Lebanon, Liechtenstein, Malaysia, Mexico, Moldova, New Zealand, Nicaragua, Norway, Oman, Pakistan, Panama, Peru, the Philippines, Qatar, Russia, Serbia, Singapore, South Africa, South Korea, Switzerland, Taiwan, Thailand, Ukraine, Uruguay, the US, and Venezuela for use in combination with irinotecan in patients with EGFR-expressing mCRC who have failed prior irinotecan therapy. In the European Union, the license was updated in July 2008 for the treatment of patients with epidermal growth factor receptor (EGFR) expressing, KRAS wild-type mCRC (metastatic colorectal cancer) 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. Apart from the European Union label, Erbitux is also approved for single-agent use in: Argentina, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Hong Kong, Iceland, Japan, Lebanon, Liechtenstein, Mexico, Moldova, New Zealand, Nicaragua, Norway, Panama, Peru, the Philippines, Russia, Singapore, Thailand, the US, and Venezuela.

In addition, Erbitux in combination with radiotherapy has been approved for the treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN) in 70 countries: Argentina, Australia, Belarus, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, El Salvador, the European Union, Guatemala, Hong Kong, Iceland, India, Indonesia, Israel, Kazakhstan, Kuwait, Lebanon, Liechtenstein, Malaysia, Mexico, Moldova, New Zealand, Nicaragua, Norway, Oman, Pakistan, Panama, Peru, the Philippines, Qatar, Russia, Serbia, Singapore, South Africa, South Korea, Switzerland, Taiwan, Ukraine, Uruguay, the US, and Venezuela. In Argentina, Chile, Costa Rica, El Salvador, Guatemala, Hong Kong, Israel, Lebanon, Mexico, Moldova, Nicaragua, Peru, the Philippines, Russia, and the US, Erbitux is also approved as monotherapy in patients with recurrent and/or metastatic SCCHN who failed prior chemotherapy. In the European Union, the license was updated in November 2008 for use in combination with platinum-based chemotherapy in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.

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., Bellevue, Washington, USA.

About Merck Serono

Merck Serono is the division for innovative prescription pharmaceuticals of Merck, a global pharmaceutical and chemical group. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. Its North American business operates in the United States and Canada as EMD Serono.

Merck Serono has leading brands serving patients with cancer (Erbitux®), multiple sclerosis (Rebif®), infertility (Gonal-f®), endocrine and cardiometabolic disorders (Glucophage®, Concor®, Saizen®, Serostim®), as well as psoriasis (Raptiva®).

With an annual R&D investment 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.

http://www.merckserono.net
http://www.merck.de

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