EGFR-targeted therapy improves survival rates in metastatic colorectal cancer patients

Sep 23 2009

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced that Erbitux^® (cetuximab) demonstrated a significant improvement in overall survival (OS) when added to standard 1^st-line chemotherapy for metastatic colorectal cancer (mCRC) patients with KRAS wild-type tumors. This is the first time an OS benefit has been demonstrated with an epidermal growth factor receptor (EGFR)-inhibitor in this disease setting. These results from the pivotal CRYSTAL^a trial were presented at the joint 15^th Congress of the European Cancer Organisation (ECCO) and 34^th Congress of the European Society for Medical Oncology (ESMO) held in Berlin, Germany this week.

“Overall survival is a critically important outcome in metastatic colorectal cancer so it is extremely rewarding to achieve this result for the first time with an EGFR-targeted therapy added to a standard chemotherapy,” commented Professor Eric Van Cutsem, principal investigator of the CRYSTAL study and Professor of Medicine and Digestive Oncology from the University Hospital Gasthuisberg in Leuven, Belgium. “We are excited to be the first to demonstrate this with Erbitux – a result that has the potential to significantly extend the lives of patients with KRAS wild-type tumors.”

CRYSTAL overall survival data

In patients with KRAS wild-type tumors receiving Erbitux plus FOLFIRI:

• Median OS was 23.5 months compared to 20.0 months in those receiving chemotherapy alone (hazard ratio [HR] 0.796;>
• The risk of disease progression was reduced by 30% (HR 0.696;>
• The likelihood of achieving a tumor response doubled overall (RR 57.3% vs. 39.7%; p<0.0001)¹

OPUS overall survival data

The unparalleled CRYSTAL results are further supported by new data from the OPUS study, also presented today, demonstrating:

• Median OS in patients with KRAS wild-type tumors of 22.8 months was seen in the Erbitux plus chemotherapy arm compared with 18.5 months in the chemotherapy-alone arm (HR 0.855;>2

These OS data were presented alongside a meta-analysis of the CRYSTAL and OPUS^b studies which demonstrated improvements in several critical outcomes for mCRC patients with KRAS wild-type tumors treated with Erbitux plus chemotherapy.

CRYSTAL/OPUS meta-analysis

The meta-analysis was designed to evaluate OS, progression-free survival (PFS) and response rate (RR) in the combined CRYSTAL and OPUS populations of patients with KRAS wild-type tumors>

• The risk of death was reduced by 19% (HR 0.81;>
• The risk of disease progression was reduced by 34% (HR 0.66; p<0.0001) for patients receiving Erbitux plus chemotherapy compared with those receiving chemotherapy alone
• The likelihood of achieving a response in patients receiving combination treatment increased more than two-fold compared to those receiving only chemotherapy (odds ratio [OR] 2.16; p<0.0001)¹

Dr. Wolfgang Wein, Executive Vice President, Oncology, Merck Serono, concluded, “These results from the meta-analysis show that Erbitux is the first and only targeted therapy to achieve a significant survival benefit in combination with the standard chemotherapy regimens FOLFOX and FOLFIRI in 1^st-line mCRC patients with KRAS wild-type tumors.”

Colorectal cancer

More than 370,000 people develop colorectal cancer in Europe every year, accounting for 13% of the total cancer burden and around 200,000 deaths.³ Approximately 25% of patients present with metastatic disease.⁴ Five-year survival rates for patients with mCRC are as low as 5%.⁵

^aCRYSTAL: Cetuximab combined with iRinotecan in first line therapY for metaSTatic colorectAL cancer

^bOPUS: OxaliPlatin and cetUximab in firSt-line treatment of mCRC