Merck KGaA announced that Erbitux (cetuximab) combined with vinorelbine plus cisplatin met the primary endpoint of increasing overall survival compared with chemotherapy alone in a phase III study initiated by Merck Serono in patients with advanced non-small cell lung cancer (NSCLC).

This randomized multinational trial, known as FLEX (First-Line Treatment for Patients with EGFR-EXpressing Advanced NSCLC), involved patients with Stage IIIB or Stage IV non-small cell lung cancer who were randomized to treatment with chemotherapy and Erbitux or with chemotherapy alone and who had not previously received chemotherapy.

"Non-small cell lung cancer that has spread from the primary site is extremely difficult to treat so we are delighted with these results," said Dr. Wolfgang Wein, senior executive vice president, Oncology, Merck Serono. "Erbitux is the first targeted agent that when combined with platinum-based chemotherapy has demonstrated a therapeutic benefit in a first-line NSCLC study that included all histological subtypes. These are important results given that recent trials involving other targeted therapies such as Tyrosine Kinase inhibitors have failed to demonstrate a benefit for patients in this setting."

In Europe, there are approximately 400,000 new cases of lung cancer each year, accounting for 22% of all new cancer diagnoses. The incidence is higher among men in eastern countries than in western countries. Non-small cell lung cancer accounts for around 80% of cancers of the lung. The five-year survival for patients with Stage III NSCLC who have radiotherapy and chemotherapy is 7-17%; for Stage IV disease, overall five-year survival is 2%. In Europe, lung cancer is the principal cause of cancer deaths in men (22%) and the third-leading cause in women (9%).

FLEX is a randomized Phase III study of Erbitux plus chemotherapy (cisplatin plus vinorelbine) or chemotherapy alone in previously untreated patients with histologically or cytologically confirmed Stage IIIB with documented malignant pleural effusion or Stage IV non-small cell lung cancer, plus immunohistochemical evidence of EGFRexpression on tumour tissue, and the presence of at least one bidimensionally measurable index lesion not lying within an irradiated area. The primary endpoint was overall survival time. Other secondary endpoints included progression free survival time, response rate, safety and quality of life.