Merck Serono has submitted an application to the European Medicines Agency (EMEA) to license Erbitux (cetuximab) for the 1st-line treatment of epidermal growth factor receptor (EGFR) expressing, advanced or metastatic non-small cell lung cancer (NSCLC).

The submission is supported by data from the phase III FLEXa study presented this year at a plenary session of the American Society of Clinical Oncology (ASCO) Annual Meeting. The study demonstrated a significant increase in overall survival for patients receiving Erbitux in combination with a platinum-based chemotherapy as a 1st-line treatment for advanced NSCLC.

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 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.

"Erbitux represents the first significant and clinically relevant advance in 10 years in the treatment of such a broad patient population in NSCLC," said Dr Wolfgang Wein, executive vice president, Oncology, Merck Serono. "If approved in NSCLC Erbitux would not only provide physicians with a new important option for the therapy of this aggressive and difficult-to-treat cancer, it will also enable a greater number of cancer patients in Europe to benefit from treatment with Erbitux."

Erbitux is already licensed in the European Union for all lines of treatment for patients with EGFR-expressing, KRAS wild-type metastatic colorectal cancer (mCRC) in combination with chemotherapy, and as a single agent for patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan. Erbitux is also licensed in combination with radiotherapy for locally advanced squamous cell carcinoma of the head and neck (SCCHN). In addition, Merck Serono submitted an application to the EMEA in June 2008 to broaden the use of Erbitux to include 1st-line treatment of recurrent and/or metastatic SCCHN.

Lung cancer is the most common cause of cancer death in men worldwide and the second most common in women (after breast cancer). Approximately 975,000 men and 376,000 women die from the disease each year. Around 80% of lung cancer patients present with NSCLC and approximately one-third of these patients' tumours already have advanced to the stage where surgical resection is not a viable option. The outlook for lung cancer patients is poor with an overall five-year survival rate of approximately 10%, which compares unfavourably with the rates associated with other tumor types such as melanoma (81%) or breast cancer (75%).