Bristol-Myers Squibb announces successful phase III Erbitux study

Bristol-Myers Squibb and ImClone Systems have this week announced that a trial of Erbitux (cetuximab) as a combination treatment with the vinorelbine plus cisplatin platinum-based chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) has met its primary endpoint of boosting overall survival when compared to treatment with chemotherapy alone.

The phase III Flex study was conducted by Merck KGaA and involved NSCLC patients at stage IIIB or IV not previously been treated with chemotherapy, while results are due to be submitted for presentation at a forthcoming medical conference.

Erbitux is a monoclonal antibody (IgG1 Mab) that aims to inhibit the function of the epidermal growth factor recapture expressed on the surface of both tumour and normal body cells.

Martin Birkhofer, vice-president of oncology global medical affairs at Bristol-Myers Squibb, said: “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 NSCLC,”

He added that Bristol-Myers Squibb anticipated sharing the information from the trial with the medical community.

In July 2007, Bristol-Myers Squibb and ImClone Systems announced an expansion to their previous development and promotion agreement for Erbitux, with further investment agreed for clinical development of the drug.