Merck Serono's Erbitux Significantly Extends Survival by 7.5 Months in mCRC RAS Wild-Type Patients When Compared With Bevacizumab: New Analysis of FIRE-3 AIO Study

Darmstadt, Germany/Amsterdam, The Netherlands, September 28, 2013 – Merck Serono, the biopharmaceutical division of Merck, today announced that the German cooperative investigator group AIO (Arbeitsgemeinschaft Internistische Onkologie) reported new data from the Phase III head-to-head clinical trial FIRE-3, which show a clinically relevant improvement from Erbitux® (cetuximab) plus FOLFIRI versus bevacizumab plus FOLFIRI as 1st line treatment in metastatic colorectal cancer (mCRC) in patients with RAS wild-type tumors.1 The new data, from a preplanned exploratory analysis, were presented at the European Cancer Congress 2013 (ECCO-ESMO-ESTRO). The analysis shows a 7.5-month increase in median overall survival (OS) in mCRC patients with RAS wild-type tumors ((n=342); defined as having no mutations in exons 2, 3 and 4 of KRAS and NRAS), receiving 1st line Erbitux plus FOLFIRI compared with patients receiving bevacizumab plus FOLFIRI (OS: 33.1 months vs. 25.6 months, respectively; hazard ratio [HR]: 0.70; p=0.011). In a post hoc analysis of the patient group with any RAS mutations (n=178), patients who received Erbitux plus FOLFIRI 1st line reached an OS of 20.3 months vs. 20.6 months in the group that was treated with bevacizumab plus FOLFIRI (HR: 1.09; p=0.60).1

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