Amgen has announced strong results from a Phase III trial evaluating Vectibix with FOLFIRI chemotherapy, as a second-line treatment in 1,186 patients with metastatic colorectal cancer (mCRC).
During the trial Vectibix significantly improved progression-free survival in combination with FOLFIRI, compared to FOLFIRI alone, in patients with KRAS wild-type mCRC.
The addition of Vectibix had no positive or negative effect on progression-free or overall survival in patients with tumours harbouring activating KRAS mutations.
Amgen vice-president of research and development Roger M Perlmutter said that these results add to the growing body of evidence confirming the utility of KRAS as a predictive biomarker.
“Vectibix has now demonstrated improved progression-free survival in Phase III trials in patients with KRAS wild-type tumours in first- and second-line treatment of metastatic colorectal cancer,” Perlmutter said.
Side effects were as anticipated with irinotecan-based chemotherapy and included skin toxicity, diarrhoea and hypomagnesemia.