Merck KGaA has announced that a phase III study of Erbitux (cetuximab) plus irinotecan-based therapy met the primary endpoint of increasing median duration of progression-free survival in patients with previously untreated metastatic colorectal cancer (mCRC).
This randomised phase III international trial, known as Crystal, studied patients treated with Erbitux plus Folfiri (irinotecan-based chemotherapy) compared with Folfiri alone. "We are delighted with these results. The data from this controlled clinical trial of an EGFR-targeting monoclonal antibody demonstrate an improvement in progression-free survival in the first-line treatment setting," said Dr Wolfgang Wein, senior vice president, Global Oncology Commercialisation at Merck KGaA. "They demonstrate the benefit of adding Erbitux to chemotherapy in initial, first-line treatment."
In the Crystal study, more than 1000 patients1 from around the world were recruited to detect a difference in progression-free survival for the Erbitux plus Folfiri arm compared with the Folfiri arm alone. Results have been submitted for presentation at the 2007 American Society of Clinical Oncology Annual Meeting in Chicago in June.
CRC is a major health concern, with more than 370,000 people developing colorectal cancer in Europe per year, accounting for 13 per cent of the total cancer burden and around 200,000 deaths.2 Approximately 25 per cent of patients present with metastatic disease.3 Five-year survival rates for patients with mCRC are as low as 5 per cent.4 Cetuximab combined with iRinotecan in first line therapY for metaSTatic colorectAL cancer.