Erbitux has almost double KRAS response in trial

Merck Serono, the pharmaceutical arm of Germany's Merck KGaA, has published the results of a study, demonstrating that the addition of its  Erbitux (cetuximab) to standard oxaliplatin-based chemotherapy  (FOLFOX-4) in previously-untreated metastatic colorectal cancer patients  with KRAS wild-type tumors resulted in a significantly-higher response  rate compared to chemotherapy alone, in the Journal of Clinical  Oncology.

The randomized, multicenter, Phase II OPUS trial compared the efficacy  and safety of Erbitux combined with FOLFOX versus FOLFOX alone in the  first-line treatment of epidermal growth factor receptor-expressing  mCRC. The primary objective was response rate. In the intention to treat  population, 46% of patients receiving Erbitux in combination with FOLFOX  experienced a response, compared to 36% of those treated with  chemotherapy alone (p=0.064). In a retrospective efficacy analysis it  was shown that 61% of patients with KRAS wild-type tumors responded when  treated with Erbitux plus chemotherapy, compared to 37% of subjects in  the chemotherapy alone arm (p=0.011).

"The publication of these important data represents another step towards  the new era for mCRC treatment," said senior vice president Frank Weber.  "The enhanced efficacy that Erbitux provides patients with KRAS  wild-type tumors in the first-line - as demonstrated by the high  response rates in the OPUS study - clearly supports the role of Erbitux  as a new standard-of-care for these patients," he added.