Jan 24 2010
Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today
announced that Erbitux® (cetuximab) provided an improvement
in overall survival (OS) when added to the standard 1st-line
FOLFIRI chemotherapy regimen for metastatic colorectal cancer (mCRC)
patients with KRAS wild-type tumors in the CRYSTAL study. In
addition, the final results from this study included an analysis of the
predictive value of BRAF status on Erbitux efficacy – one of the first
to be based on a large subgroup>st-line setting. The analysis indicates that
patients with KRAS wild-type tumors bearing a BRAF mutation also benefit
from Erbitux treatment; therefore, KRAS remains the only
validated, clinically predictive marker of responsiveness to this drug.
These study results were presented at the American Society of Clinical
Oncology’s 2010 Gastrointestinal Cancers Symposium (ASCO-GI) in Orlando.
“The identification of the KRAS biomarker has revolutionized the
treatment of this disease, allowing patients to receive the most
suitable treatment for their disease and resulting in improved outcomes.”
“It is clear that overall survival is a critically important outcome in
metastatic colorectal cancer, so it is extremely rewarding to achieve
this result in patients with KRAS wild-type tumors,” commented Professor
Claus-Henning Köhne, Head of the Department of Oncology and Hematology,
Klinikum Oldenburg, Germany, who presented the results of a pooled
analysis of the CRYSTAL and OPUS trials today. “The analysis indicating
that BRAF is not predictive for Erbitux efficacy is also of interest, as
it confirms the current role of KRAS as the only clinically predictive
biomarker for Erbitux.”
SOURCE Merck Serono