Trial of Vectibix vs Erbitux Meets Primary End Point for OS

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Amgen announced that its Phase 3 trial ASPECCT ('763), evaluating Vectibix (panitumumab) vs. Erbitux (cetuximab) as monotherapy for the treatment of chemo-refractory metastatic colorectal cancer (mCRC), met its primary endpoint of non-inferiority for overall survival in patients with wild-type KRAS tumors.

ASPECCT is a global, randomized, parallel assignment, open-label, Phase 3 non-inferiority trial (N=1,010) evaluating the effect of Vectibix vs. Erbitux on overall survival for mCRC in patients with wild-type KRAS tumors. Patients were randomized in a 1:1 ratio to receive either intravenous Vectibix 6mg/kg every 14 days or intravenous Erbitux 400mg/m2 starting dose followed by 250mg/m2 every seven days.

Study results demonstrated that the estimated overall survival hazard ratio (Vectibix/Erbitux) was 0.966 (95% CI: 0.839, 1.113) thus favoring the Vectibix arm.

Vectibix, a human anti-epidermal growth factor receptor (EGFR) antibody is approved for the treatment of metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

Erbitux, an epidermal growth factor receptor (EGFR) antagonist is approved for KRAS mutation-negative (wild-type), EGFR-expressing metastatic colorectal carcinoma in combination with FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) for first-line treatment, or in combination with irinotecan (if refractory to irinotecan-based chemotherapy), or as a single agent (after failure of both irinotecan- and oxaliplatin-based regimens or if irinotecan-intolerant).

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