Phase 2/3 Study Data Announced for Vectibix in Colorectal Cancer

Amgen announced new data from its PEAK and PRIME studies that support Vectibix (panitumumab), in combination with FOLFOX, as first-line therapy in patients with wild-type RAS metastatic colorectal cancer (mCRC).

In the Phase 2 PEAK (Panitumumab Efficacy in Combination with mFOLFOX6 Against bevacizumab plus mFOLFOX6 in mCRC subjects with wild-type KRAS tumors) study, treatment with Vectibix vs. Avastin (bevacizumab; Genentech) resulted in a significantly higher proportion of patients with earlier tumor shrinkage at Week 8 (64% vs. 45%; P=0.0232). Of the responders, treatment with Vectibix led to a significantly longer duration of response (11.4 vs. 8.5 months; P=0.0142) and a greater depth of response (65% vs. 46%; P=0.0007); overall response rates were similar between Vectibix and Avastin.

In the Phase 3 PRIME (Panitumumab Randomized trial In combination with chemotherapy for Metastatic colorectal cancer to determine Efficacy) study, treatment with Vectibix plus FOLFOX showed no significant difference in quality of life vs. FOLFOX alone despite treatment-related adverse events. The quality of life analysis included a scale that evaluated mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

Vectibix is a fully human anti-EGFR antibody approved as first-line treatment of wild-type KRAS metastatic colorectal carcinoma (mCRC) in combination with FOLFOX, or as monotherapy following disease progression after prior fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy as determined by an FDA-approved test.

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