Merck KGaA is expected to file its novel cancer drug Erbitux (cetuximab) for approval in head and neck cancer in Switzerland and the European Union within the next few months. It has been available since 2003 in Switzerland, and the remaining European Union member states since 2004 [[01/07/04a]], for use in the treatment of metastatic colorectal cancer. In the US, Argentina, Chile, Mexico and Australia, it is also approved as monotherapy for colorectal cancer [[13/02/04b]].
The drug, administered by intravenous infusion, is a monoclonal antibody that shrinks tumours and slows disease progression by targeting epidermal growth factor receptors on the surface of tumour cells. Speaking in Leuven last month, Dr Oliver Kisker, who leads the German company’s EGFR research and development programme, said head and neck cancer is a condition of unmet need where there have been no therapeutic advances in three decades. In a Phase III trial of 424 patients, those treated with Erbitux had a median survival of 54 months, compared to 28 months for patients receiving radiotherapy alone.
Clinical trials have shown that, when used with other chemotherapies, Erbitux achieves better response rates without increasing toxicity and helps to make previously inoperable tumours operable, he said. The product has been well received by cancer specialists and there's been rapid uptake of the product, he noted. Substantial sales growth is predicted for Erbitux, with Merck now expanding its clinical trial program into numerous other cancer sites as well as different strategies for tackling colorectal cancer.
In metastatic colorectal cancer, the company is looking at securing approval for Erbitux as a first-line therapy as well as a second-line treatment in combination with other chemotherapies. Trials are also continuing in cancers of head and neck and non small-cell lung cancer. In addition, Phase II trials are underway or planned for gastric, oesophageal and pancreatic cancers, small-cell lung cancer and for breast, ovarian and uterine cervix tumours expressing EGFR. Merck hopes to see Erbitux accepted as the standard for all tumours expressing EGFR, Dr Kisker explained.
- Meanwhile, COIN, a UK Medical Research Council Phase III trial of 2,500 patients with inoperable metastatic colorectal cancer has started. The trial will compare six months of weekly Erbitux infusions plus a regimen based on Sanofi-Aventis’ Eloxatin (oxaliplatin) against continuous standard chemotherapy or intermittent 12-week chemotherapy. The objective is to see which approach is best in achieving tumour shrinkage permitting resection of metastases and slowing progression of disease.