Vectibix(R) in Combination With Chemotherapy Significantly Improves Progression-Free Survival in First-Line Metastatic Colorec...(ectibix arm. For patients with mutant K...),Health

Date:9/24/2009

ectibix arm. For patients with mutant KRAS tumors, median PFS was 7.3 months with Vectibix in combination with FOLFOX vs. 8.8 months with FOLFOX alone (hazard ratio 1.29, p=0.02). These data confirm previous findings when oxaliplatin-based chemotherapy and an anti-epidermal growth factor receptor (EGFR) antibody are combined in patients bearing tumors with activating KRAS mutations.

Consistent with the PFS data, an interim analysis of overall survival, a secondary endpoint, demonstrated a reduction in overall survival in patients with KRAS mutant tumors receiving Vectibix. The median overall survival for patients with KRAS wild-type mCRC has not yet been reached. Long-term follow-up for survival continues and the primary analysis is expected in the fourth quarter of 2009.

Adverse event rates were comparable across arms with the exception of known toxicities associated with anti-epidermal growth factor receptor (EGFR) therapy such as rash, diarrhea and hypomagnesemia. Vectibix-related grade 3 infusion reactions were reported for two patients (less than 1 percent).

Originally designed to compare the treatment effect in the overall population, the study was amended to analyze outcomes with respect to the presence or absence of activating mutations in KRAS in the tumor itself. Tumor KRAS status was ascertained in 93 percent of the 1,183 patients enrolled in the trial, the highest percentage ever reported. Tumor KRAS tests were finalized after the completion of enrollment and prior to the primary analysis.

Earlier this week, data were presented from the '181' trial which showed that Vectibix administered in combination with FOLFIRI (an irinotecan-based chemotherapy) prolonged PFS by 2 months in patients with KRAS wild-type mCRC, compared to treatment with FOLFIRI alone (Abstract Number 14LBA).

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