ImClone and B-MS provide Erbitux update

ImClone Systems and Bristol-Myers Squibb have advanced the non-small cell lung cancer (NSCLC) clinical development program for Erbitux (Cetuximab), an IgG1 monoclonal antibody, based on clinical results from the Phase II program in first- and second-line NSCLC.

The companies will initiate a randomised Phase III clinical trial (IMCL-0452) evaluating chemotherapy alone, either with docetaxel or pemetrexed, or the same chemotherapy in combination with Erbitux in 800 patients with second-line NSCLC.

The primary endpoint of this study is tumour response rate, defined as tumour regression of greater than 50%. Secondary endpoints include progression free survival and overall survival. Based on a special protocol assessment (SPA), the FDA agreed that this study, pending its outcome, could serve as the basis for an accelerated approval of Erbitux in the second-line treatment of non-small cell lung cancer.

In addition, Merck KGaA has initiated a randomised Phase III clinical trial in Europe, Latin America and Asia (EMR-046) of a platinum-based chemotherapy and vinorelbine alone or in combination with Erbitux in 1100 patients with first-line NSCLC. The primary endpoint of this study is overall survival.

ImClone Systems and Bristol-Myers Squibb also plan to initiate two supportive first-line randomised clinical studies using chemotherapy regimens more commonly used by US physicians, including a taxane with platinum-based chemotherapy and gemcitabine with platinum-based chemotherapy, plus or minus Erbitux. Each of these two studies has tumour response rate as its primary endpoint.

Pending their outcome, these three clinical trials could allow the companies to seek an indication in first-line treatment with platinum-based chemotherapy. Additionally, a study sponsored by the Southwest Oncology Group will evaluate the efficacy of concurrent chemotherapy plus Erbitux and chemotherapy followed by Erbitux in 180 patients with non-small cell lung cancer.