Source: www.medicalnewstoday.com
Author: staff

Merck Serono’s Erbitux® is one of the finalists for the prestigious International Prix Galien Award for excellence in pharmaceutical development and innovation due to its role in transforming the treatment of head and neck cancer.

Erbitux is the first and only targeted therapy approved for the treatment of squamous cell carcinoma of the head and neck (SCCHN) and works in a completely different way to conventional chemotherapies. Through its targeted mode of action, Erbitux blocks the epidermal growth factor receptor (EGFR), which is expressed in more than 90% of SCCHN tumors1 and is directly related to a poor prognosis for patients. The efficacy and tolerability of this novel drug have been shown in clinical trials2 – the latest of which, EXTREMEa, demonstrated the first significant advance in 30 years for the treatment of recurrent and/or metastatic SCCHN. 3

“We are very pleased that Erbitux has been short-listed for arguably the most prestigious award in our industry,” said Dr Wolfgang Wein, Executive Vice President, Oncology, Merck Serono. “This recognizes not only the outstanding clinical excellence of Erbitux but also the significant breakthrough that the drug offers patients with head and neck cancer, which is so difficult to treat. Merck Serono is passionate about advancing research across a range of oncology indications and improving the treatments available to cancer patients.”

Erbitux is licensed in locally-advanced SCCHN on the basis of data demonstrating that in combination with radiotherapy it achieved locoregional control for more than two years, almost 20 months more than with radiotherapy alone and without increasing the common side effects often observed following such treatment.2 Five-year survival data from the same trial recently presented at the 50th American Society for Therapeutic Radiology and Oncology (ASTRO) Annual Meeting in Boston showed that nearly half of the patients receiving Erbitux were alive at five years and Erbitux provides a diminution of 27% of the risk of death and an absolute survival benefit of 10% at five years compared to radiotherapy alone. 4

Erbitux is also demonstrating promise in the treatment of 1st line recurrent and/or metastatic SCCHN. New data from the pivotal EXTREME trial, recently published in the New England Journal of Medicine, demonstrated that when used in combination with traditional chemotherapy, Erbitux provides significant increases in overall survival, median progression-free survival and tumor response rate in the 1st-line treatment setting. 3 These results from the EXTREME trial have been used to support an EMEA application to broaden the use of Erbitux to include 1st-line treatment of recurrent and/or metastatic SCCHN, submitted in June 2008.

Erbitux was announced as the winner of the French Prix Galien Award in 2007 and was then submitted to the International Award competition in June 2008. Winners of the 10th International Prix Galien award will be announced in Berlin on October 30, 2008.

About the Prix Galien Award
The Prix Galien Award was established in France in 1970 to recognize outstanding achievement and innovation in medical research and development. Winners of National Prix Galien Awards can then enter the International Prix Galien Awards which take place every two years.

Head and Neck Cancer
Head and neck cancer includes cancers of the tongue, mouth, salivary glands, pharynx, larynx, sinus, and other sites located in the head and neck area. It is the sixth most frequently occurring cancer worldwide and, in Europe alone, it is estimated that there are around 143,000 cases of head and neck cancer, and more than 68,000 deaths due to the disease each year. 5 About 40% of patients with head and neck cancer have recurrent and/or metastatic SCCHN. 6 About 90% of head and neck cancers are of the squamous cell variety7 and nearly all express EGFR. 8 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 secondary tumors, in addition to suffering from other co-morbidities. 9 At least 75% of all head and neck cancers are attributed to its two major risk factors, smoking tobacco and alcohol consumption. 10

References
1. 1 – Vo-Nguyen TT & Ondrey F. Otolaryngol Head Neck Surg 2004;131(2):P177.
2. 2 – Bonner J, et al. N Eng J Med 2006;354:567-78.
3. 3 – Vermorken JB, et al. N Eng J Med 2008;359:1116-27.
4. 4 – Bonner J, et al. Late-breaking clinical trial update at ASTRO Congress 2008, Boston, MA, USA, 22 September.
5. 5 – GLOBOCAN 2002 (www-dep.iarc.fr). Last accessed August 2008.
6. 6 – Lefebvre J-L. Ann Oncol 2005;16(Suppl 6):vi7-vi12.
7. – 7Hunter KD, et al. Nat Rev Cancer 2005;5(2):127-35.
8. 8 – Grandis JR, Tweardy DJ. Cancer Res 1993;53(15):3579-84.
9. 9 – Forastiere A, et al. N Engl J Med 2001;345(26):1890-900.
10. 10 – Hashibe M, et al. J Natl Cancer Inst 2007;99:777-89.

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 75 countries. It has been approved for the treatment of colorectal cancer in 74 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, 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 69 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, 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.

Merck licensed the right to market Erbitux outside the US and Canada from ImClone Systems Incorporated of New York in 1998. In Japan, ImClone Systems Incorporated, 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.