Amgen Reports Positive Top-Line Results For Phase 3 Vectibix Trial

Amgen has reported positive top-line results from a phase 3 trial evaluating Vectibix (panitumumab) in combination with Folfiri (an irinotecan-based chemotherapy) as a second-line treatment in 1,186 patients with metastatic colorectal cancer (mCRC).

The study shows the co-primary endpoints, tested independently, were progression-free and overall survival.

Vectibix significantly improved progression-free survival in combination with Folfiri compared to Folfiri alone, in patients with KRAS wild-type mCRC. Although numerically greater, the improvement in median overall survival did not achieve statistical significance in the Vectibix arm.

The addition of Vectibix had no positive or negative effect on progression-free or overall survival in patients with tumors harboring activating KRAS mutations.

Recently, the company has announced phase 3 results from a first-line 203 trial which showed that Vectibix significantly improved progression-free survival in mCRC patients with KRAS wild-type tumors in combination with Folfox (an oxaliplatin-based chemotherapy).

Roger Perlmutter, executive vice president of Research and Development at Amgen, said: With these data, Vectibix has now demonstrated improved progression-free survival in phase 3 trials in patients with KRAS wild-type tumors in both first- and second-line treatment of metastatic colorectal cancer. These results add to the growing body of evidence confirming the utility of KRAS as a predictive biomarker.