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Amgen Announces Overall Survival Results for Vectibix(R) in First-Line Metastatic Colorectal Cancer
Date:11/5/2009

ombination with oxaliplatin-based chemotherapy, including known events such as rash, diarrhea and hypomagnesemia. Vectibix-related grade 3 infusion reactions were reported for two patients (less than 1 percent).

Originally designed to compare the treatment effect in the overall population, the study was amended to analyze outcomes with respect to the presence or absence of activating mutations in KRAS in the tumor itself. Tumor KRAS status was ascertained in more than 90 percent of the 1,183 patients enrolled in the trial.

Available results from the trial were presented earlier this year at the 2009 ECCO 15 - ESMO 34 European Multidisciplinary Congress in Berlin, Germany showing that Vectibix significantly improved median progression-free survival by 1.6 months (9.6 versus 8.0 months for patients treated with FOLFOX alone, in patients with KRAS wild-type mCRC (primary endpoint). Further, the addition of Vectibix to chemotherapy also improved response rate in the KRAS wild-type patient population as measured by blinded central review (55 percent versus 48 percent in the FOLFOX only arm).

The data for the 203 study has been submitted for consideration of presentation at the American Society of Clinical Oncology - The Gastrointestinal Cancers Symposium Meeting for 2010.

Study Design

Patients enrolled in the "203" or PRIME trial (Panitumumab Randomized trial in combination with chemotherapy for Metastatic colorectal cancer to determine Efficacy) were randomized to receive either 6.0 mg/kg of Vectibix and FOLFOX4 once every two weeks (Q2W) or FOLFOX4 alone Q2W. The primary endpoint of the study is progression-free survival by KRAS status and secondary endpoints include overall survival, objective response rate, time to progression, duration of response and safety.

About KRAS

Results from studies performed over the last twenty-five y
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SOURCE Amgen
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