Amgen announces Phase 3 results evaluating Vectibix in combination with FOLFIRI chemotherapy

August 02, 2017

In general, adverse events 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 3/4 infusion reactions were reported in less than one percent of patients.

There were no differences in progression-free survival, overall survival and response rates among patients with mutated KRAS who received Vectibix.

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 91 percent of the 1,186 patients enrolled in this trial, the highest number ever reported for a second-line trial.

"These high quality prospectively defined analyses prove the clinical utility of KRAS as a predictive biomarker in metastatic colorectal cancer patients," added Peeters.