Bristol-Myers Squibb announces Erbitux phase III results

Bristol-Myers Squibb and ImClone Systems have announced that their phase III clinical trial of Erbitux (cetuximab) administered with irinotecan-based chemotherapy Folfiri met its primary endpoint of improving progression-free survival in patients with metastatic colorectal cancer compared with treatment solely with Folfiri.

The Crystal study was conducted by Merck KGaA, a partner of ImClone Systems, a company that develops targeted biologic treatments to treat patients with a range of cancers.

ImClone reports that metastatic disease is hard to treat, with the recent study showing that Erbitux had exhibited potential improvements to first-line treatment of metastatic colorectal cancer through the addition of Erbitux.

Erbitux is a monoclonal antibody (IgG1 Mab) that aims to reduce the epidermal growth factor receptor (EGFR, HER1, c-ErbB-1) on the surface of both tumour cells and normal cells in the body.

The compound is indicated for the treatment of locally or regionally advanced squamous cell carcinoma.

Martin Birkhofer, vice president of oncology global medical affairs at Bristol-Myers Squibb, said: “These results provide important new information for patients with metastatic colorectal cancer and are part of a comprehensive clinical development programme designed to fully understand the potential uses of Erbitux for cancer patients.”

Last year, Bristol-Myers Squibb announced the results of two trials of Erbitux, where the primary endpoint was met in the NCIC CTG study, though not in the Epic study, though secondary endpoints favoured a combination including Erbitux.