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Merck at ASCO 2007: Spectrum of Studies Reinforces Promise of,Erbitux for Colorectal and Head and Neck Cancer Patients

CHICAGO, DARMSTADT, Germany, June 5, 2007 – This year’s American Society of Clinical Oncology (ASCO) meeting in Chicago sees a wealth of promising new data presented regarding Merck KGaA’s targeted cancer therapy Erbitux® (cetuximab), further demonstrating the consistent efficacy and versatility of this agent in both first-line and subsequent treatment of metastatic colorectal cancer (mCRC) and squamous cell carcinoma of the head and neck (SCCHN).

Two new studies presented at the meeting validate the role of Erbitux as an effective first-line treatment in mCRC patients, when used in conjunction with two different types of chemotherapy treatment. The CRYSTAL(a) trial, a phase III study of Erbitux plus FOLFIRI (irinotecan-based therapy) compared with FOLFIRI alone, met the primary endpoint of significantly increasing median duration of progression-free survival in patients with previously untreated mCRC. This randomized, controlled international trial studied over 1,000 patients and demonstrated a statistically significant increase of progression-free survival in the Erbitux/FOLFIRI group (8.9 months) compared with the FOLFIRI group (8 months) (p=0.0479). However, this is a point estimate; more importantly, the overall curve showed a 15% reduction in the risk of metastatic colorectal cancer growing or spreading. The study also achieved its secondary endpoint of significantly increasing response rate (tumor shrinkage by 50% or more) (47% in the Erbitux plus FOLFIRI group compared to 39% in the FOLFIRI alone group). Furthermore, in a subgroup analysis, patients who had liver metastases only had the highest PFS (11.4 months with Erbitux vs. 9.2 months in the control arm) and a 36% reduction in the risk of metastatic colorectal cancer growing or spreading. The number of complete resections of the metastases in the subgroup who had liver metastases only was more than double with Erbitux plus FOLFIRI vs. control arm (9.8% versus 4.5%). The nu
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