This improvement in survival was observed across all histological subtypes, patient performance status, age groups, previous smoking history, and gender.
The pivotal, multinational study known as Flex was planned and conducted by Merck KGaA, Darmstadt, Germany, and enrolled more than 1,100 patients with Stage IIIB or Stage IV non-small cell lung cancer (NSCLC) who had not previously received chemotherapy.
Unlike previous pivotal studies of monoclonal antibodies in NSCLC, the Flex study enrolled patients with a broad range of performance capabilities and histological subtypes – reflective of physicians’s everyday practice. For patients receiving Erbitux in combination with chemotherapy, median overall survival was prolonged by 1.2 months when compared to chemotherapy alone (11.3 months versus 10.1 months) for an hazard ratio of 0.871 [95% CI = 0.762-0.996], p=0.044.
Eric Rowinsky, executive vice president and chief medical officer of ImClone, said: “We look forward to submitting a supplemental biologics license application, or sBLA, later this year for Erbitux to be used in the first-line treatment of patients with non-small cell lung cancer on the basis of the Flex study results.”