Amgen’s Vectibix phase 3 study meets primary endpoint

A statistically significant improvement was demonstrated in overall survival (OS) in patients with chemorefractory wild-type KRAS (exon 2) metastatic colorectal cancer.

It is first phase 3 Vectibix trial to include a prespecified analysis of efficacy endpoints by RAS tumor status in primary analysis.

A total of 377 patients were enrolled in the study and were randomized 1:1 to receive 6 mg/kg of Vectibix every 14 days and BSC, or BSC alone.

The secondary endpoints of the study included progression-free survival (PFS) in patients with wild-type KRAS mCRC, as well as OS and PFS in patients with wild-type RAS mCRC, objective response rate and safety in both wild-type exon 2 and wild-type RAS groups.

Amgen executive vice president of research and development Sean Harper said: "Amgen has played a significant role in the advancement of personalized medicine, applying cutting-edge science and technology in our efforts to target therapies to the patients who are most likely to benefit.

"As well as providing additional insights into the way Vectibix works in mCRC, these data support expanding biomarker screening to include wild-type RAS."

The US Food and Drug Administration approved Vectibix to treat metastatic colorectal cancer (mCRC).

Vectibix, is the first fully human monoclonal anti-epidermal growth factor receptor antibody, was approved in the US in September 2006 as a monotherapy for the treatment of patients with EGFR-expressing mCRC after disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy.

It is not indicated to treat patients with RAS-mutant mCRC or for whom RAS mutation status is not known.