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Amgen Receives Positive CHMP Opinion for Vectibix® (Panitumumab) in Combination With Chemotherapy
Date:6/24/2011

ectibix plus FOLFOX significantly  improved PFS versus FOLFOX alone (median 9.6 months versus 8.0 months, hazard ratio (HR) 0.80; 95 percent confidence interval (CI): 0.66-0.97; p=0.02).(i)  Additionally, combining Vectibix with FOLFOX resulted in numerically greater OS versus FOLFOX alone (median 23.9 months versus 19.7 months, HR 0.83; 95 percent CI: 0.67-1.02), although this was not statistically significant (p=0.072).(i)  The ORR achieved with Vectibix plus FOLFOX was higher than FOLFOX alone (55 percent versus 48 percent).(i)

The '181 study showed that adding Vectibix (6.0 mg/kg every two weeks) to FOLFIRI chemotherapy improved median PFS by two months in patients with wild-type KRAS mCRC compared to FOLFIRI alone (median 5.9 months versus 3.9 months; HR 0.73, 95 percent CI: 0.59-0.90; p=0.004). Additionally, the Vectibix combination more than tripled the ORR compared to FOLFIRI alone (35 percent versus 10 percent). Though quantitatively greater (14.5 months versus 12.5 months, HR 0.85), the improvement in median OS (co-primary endpoint) did not achieve statistical significance in the Vectibix arm of the trial (p=0.12).(ii)

Adverse event rates included known toxicities associated with anti-epidermal growth factor receptor (EGFR) therapy, such as rash, diarrhea, and hypomagnesemia. Vectibix-related grade 3/4 infusion reactions were reported in less than one percent of patients. (i)  In patients with mutated KRAS tumors, outcomes were inferior for those receiving Vectibix plus FOLFOX versus FOLFOX alone.(ii iii) Vectibix should only be used in those patients in whom wild-type KRAS status has been confirmed, because of the worse outcomes in patients with mutated KRAS tumors treated with FOLFOX.

The Amgen PRIME and '181 studies were the first Phase 3 studies to prospectively analyze the effect of an EGFR inhibitor based on KRAS status in patients with mCRC.

Vectibix is already approv
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