Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that it has submitted an indication extension to the European Medicines Agency (EMA) for the approval of Erbitux® (cetuximab) in combination with standard 1st line platinum-based chemotherapy in patients with advanced or metastatic non-small cell lung cancer (NSCLC) with high epidermal growth factor receptor (EGFR) expression.

The submission is based on a new biomarker analysis of EGFR expression levels in tumours of patients participating in the Phase III FLEXa study. New data, presented at the Chicago Multidisciplinary Symposium in Thoracic Oncology in December 2010, showed that, among patients with high EGFR expression, the response rate was significantly increased by the addition of Erbitux to standard chemotherapy from 28.1% to 44.4% (p=0.002).[1] Merck Serono analysed further clinical data for the submission and plans to present additional results at upcoming congresses.

In the UK, lung cancer is the second most common cancer diagnosed after breast cancer. Around 41,000 people were diagnosed with lung cancer in the UK in 2008 (22,800 men and 17,900 women).[2] NSCLC accounts for approximately 80% of all lung cancer cases.[3] At diagnosis, most patients with NSCLC present with advanced, non-operable (also called unresectable) disease, which is associated with a very poor prognosis.[4] NSCLC remains difficult to treat with very few new effective drugs identified over the last ten years. The overall 5-year survival rate for lung cancer is about 10%, compared to 81% for melanoma and 75% for breast cancer.[5]

a FLEX: First-line in Lung cancer with ErbituX

About Erbitux

Erbitux® is a first-in-class 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 tumour cells and the spread of tumours to new sites. It is also believed to inhibit the ability of tumour cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumours, which appears to lead to an overall suppression of tumour growth.

The most commonly reported side effect with Erbitux is an acne-like skin rash that may be correlated with a good response to therapy.

Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, KRAS wild-type metastatic colorectal cancer in combination with chemotherapy, or as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.

Erbitux is aslo indicated for the treatment of patients with squamous cell cancer of the head and neck in combination with radiation therapy for locally advanced disease, or in combination with platinum-based chemotherapy for recurrent and/or metastatic disease.

Erbitux has obtained market authorisation in 87 countries. It has been approved for the treatment of colorectal cancer in 87 countries and for the treatment of squamous cell carcinoma of the head and neck (SCCHN) in 84 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 is also investigating several other potential cancer treatments for a variety of tumour sites.

References

[1] O'Byrne K, et al. Chicago Multidisciplinary Symposium in Thoracic Oncology 2010. Abstract No. LBOA1.

[2] Cancer Research UK. Lung cancer - UK incidence statistics.

[3] D'Addario, et al. Ann Oncol 2008;19(Suppl 2):ii39-40.

[4] Bunn PA, et al. Oncologist 2008;13(Suppl 1):1-4.

[5] Sant M, et al. Ann Oncol 2003;14(Suppl 5):v61-118.

Source:
Merck Serono

View drug information on Erbitux.