Cetuximab Meets Primary Endpoint of Increasing Survival in Phase III Lung Cancer Study

ImClone Systems Incorporated and Bristol-Myers Squibb Company announced that a phase III study of cetuximab (Erbitux) in combination with platinum-based chemotherapy (vinorelbine plus cisplatin) met its primary endpoint of increasing overall survival compared with chemotherapy alone in patients with advanced non–small-cell lung cancer (NSCLC). This large, randomized multinational study, known as FLEX (First-Line Treatment for Patients with Epidermal growth factor inhibitor (EGFR)-EXpressing Advanced NSCLC) was conducted by Merck KGaA, Darmstadt, Germany and enrolled patients with stage IIIB or stage IV NSCLC who had not previously received chemotherapy.

"Based on the FLEX results, Erbitux is the only member of the class of epidermal growth factor inhibitors to demonstrate survival in the first-line treatment of patients with advanced non–small-cell lung cancer. Previous pivotal trials involving other agents targeting EGFR have failed to demonstrate a survival advantage for these patients," stated Eric K. Rowinsky, MD, chief medical officer and senior vice president of ImClone Systems. "These are important results for lung cancer patients and health-care professionals treating this devastating disease, since there have been very few treatment advances for lung cancer in recent years."

"Studies have shown that Erbitux improves overall survival for patients with certain head and neck cancers, and now, with the FLEX data, for patients with advanced non–small-cell lung cancer," said Martin Birkhofer, MD, vice president, Oncology Global Medical Affairs, Bristol-Myers Squibb. "We look forward to sharing these data with the medical community."