Initial COIN study results presented at European Oncology Congress
Source: Drugs.com Author: Staff • Results inconsistent with data from all Erbitux pivotal studies • Further analyses planned by the Medical Research Council that conducted the independent COIN study Berlin/Darmstadt, Germany, September 23, 2009 – The Medical Research Council (MRC), a UK-based, publicly-funded organization dedicated to improving human health, today presented the initial results of the independent Phase III COINa study, which did not meet its primary endpoint of overall survival (OS).1 These findings were presented today at the joint 15th Congress of the European Cancer Organisation (ECCO) and 34th Congress of the European Society for Medical Oncology (ESMO) in Berlin, Germany. The COIN study was designed to evaluate whether the addition of Erbitux® (cetuximab) to one of two oxaliplatin-based chemotherapy regimens significantly improved outcomes in previously untreated metastatic colorectal cancer (mCRC) patients with KRAS wild-type tumors. The median OS was not statistically significant at 17.0 months in the Erbitux treatment arm compared to 17.9 months for the chemotherapy-alone group (hazard ratio [HR] 1.038; p=0.68).1 “Imbalances in the chemotherapy administered between the different study arms were reported previously in the interim safety analysis,” explained Dr. Wolfgang Wein, Executive Vice President, Oncology, Merck Serono, a division of Merck KGaA, Darmstadt, Germany. “Further analysis of the dose intensity and 2nd-line treatment, and other factors, such as the advanced disease of patients in the study, are ongoing to determine why the COIN results are not aligned with existing evidence from the other randomized, 1st-line studies, including the significant increase in overall survival achieved with the CRYSTAL study.” Results [...]