Bristol-Myers Squibb announces positive Erbitux trial results

Bristol-Myers Squibb and ImClone Systems have announced the results of a phase III clinical trial of Erbitux (cetuximab) in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).

In combination with platinum-based chemotherapy, the compound met its primary endpoint of increasing overall survival in patients with the disease.

The Extreme trial involved 400 patients and compared those treated with Erbitux as a combination treatment with carboplatin plus 5-fluorouracil (5-FU) or cisplatin plus 5-FU with those solely treated with carboplatin plus 5-FU or cisplatin plus 5-FU.

Eric Rowinsky, chief medical officer and senior vice-president of ImClone Systems, said: “We are excited by the results of this study, as it is the first large, randomised clinical trial to examine the impact of Erbitux treatment in combination with platinum-based chemotherapy on overall survival in metastatic head and neck cancer.”

He added that the compound had previously exhibited an improved survival rate in locoregionally advanced head and neck cancer when combined with radiation therapy.

In January 2007, Bristol-Myers Squibb reported that Erbitux plus Folfiri had met its primary endpoint in a phase III clinical study. The treatment increased median duration of progression-free survival in patients with metastatic colorectal cancer compared to those treated only with Folfiri.