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

THOUSAND OAKS, Calif., Nov. 5 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) today announced that the Phase 3 PRIME "203" trial evaluating Vectibix® (panitumumab) administered in combination with FOLFOX (an oxaliplatin-based chemotherapy) as a first-line treatment of metastatic colorectal cancer (mCRC) failed to meet a secondary endpoint of overall survival. Earlier this year, it was announced that the trial met its primary endpoint by significantly prolonging progression-free survival (PFS) in the first-line treatment of patients with KRAS wild-type mCRC.

The prospective analysis of the 203 study showed that Vectibix, when added to a FOLFOX chemotherapy regimen in patients with KRAS wild-type mCRC, resulted in a median overall survival of 23.9 months compared to 19.7 months for patients treated with FOLFOX alone. The median overall survival difference of 4.2 months in the Vectibix arm did not reach statistical significance (HR=0.83, p=0.072).

"As we previously announced, the 203 study met its primary endpoint of progression-free survival in the first-line treatment of patients with KRAS wild-type metastatic colorectal cancer," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "While not statistically significant, we are also encouraged by the positive trend of the data for overall survival for these patients treated with Vectibix."

Overall survival appeared to be reduced in patients with KRAS mutant tumors receiving Vectibix. Although not statistically significant, this result emphasizes the importance, as described in product labeling, of ensuring that patients receiving Vectibix( )do not bear tumors containing KRAS mutations.

Overall, the adverse event profile was as anticipated for an anti-EGFR antibody in c
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