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Phase 3 Trial Comparing Vectibix® (Panitumumab) To Erbitux® (Cetuximab) Meets Primary Endpoint Of Non-Inferiority Of Overall Survival

THOUSAND OAKS, Calif., Sept. 28, 2013 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced detailed results from the Phase 3 ASPECCT ('763) trial comparing Vectibix ® (panitumumab) to Erbitux ® (cetuximab) for the treatment of wild-type KRAS metastatic colorectal cancer in patients who have not responded to chemotherapy. The study met its primary endpoint, demonstrating that panitumumab was non-inferior to cetuximab for overall survival. The results were presented in an oral presentation at the 17th ECCO - 38th ESMO - 32nd ESTRO European Cancer Congress in Amsterdam (Abstract No. 18).

The prospective study showed that the median overall survival for patients treated with panitumumab was 10.4 months (range 9.4 months to 11.6 months) compared to 10 months (range 9.3 months to 11.0 months) for patients treated with cetuximab (95 percent CI, 0.84-1.11, p=0.0007).

Colorectal cancer is the second leading cause of cancer deaths. 1,2 Approximately 1.2 million cases of colorectal cancer are expected to occur globally.



"ASPECCT was a well-conducted and robust Phase 3 trial involving nearly 1,000 patients globally with metastatic colorectal cancer," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Colorectal cancer is a devastating disease and these results provide physicians with important new information about the role Vectibix can play as they evaluate treatment options."

In the study, progression-free survival was a median of 4.1 months in patients treated with panitumumab versus 4.4 months in patients treated with cetuximab (HR=1.00, 95 percent CI, 0.88, 1.14). Objective response rate, which is the percentage of patients who experienced tumor size reduction, was 22 percent for patients treated with panitumumab compared to 19.8 percent for patients in the cetuximab arm (Odds Ratio 1.15, 95 percent CI, 0.83, 1.58).

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