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Two Pivotal Vectibix® Phase 3 Studies in First and Second-Line Treatment of Metastatic Colorectal Cancer Published in the Journal of Clinical Oncology
Date:10/4/2010

THOUSAND OAKS, Calif., Oct. 4 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) today announced that results from the PRIME '203' and '181' pivotal Phase 3 trials evaluating Vectibix® (panitumumab) in combination with chemotherapy (FOLFOX or FOLFIRI) as a first and second-line treatment for metastatic colorectal cancer (mCRC), respectively, were published online in the Journal of Clinical Oncology.

"Both studies demonstrated that Vectibix administered with chemotherapy significantly improved progression-free survival in patients with wild-type KRAS mCRC," said Marc Peeters, M.D., Ph.D., Professor of Oncology, Antwerp University Hospital and '181' trial lead investigator and study author. "The adverse event profiles in both trials were as expected for an anti-EGFR antibody treatment used in combination with these types of chemotherapy regimens. Additionally, these data reinforce that KRAS status should be known when choosing treatment strategies."

PRIME '203' Results in First-Line mCRC Demonstrate Vectibix Combined with Chemotherapy (FOLFOX) Helped Patients with Wild-type KRAS mCRC Live Longer Without their Disease Worsening (Progression-Free Survival or PFS)

  • The addition of Vectibix to FOLFOX (an oxaliplatin-based chemotherapy) significantly improved PFS (median 9.6 months for Vectibix plus FOLFOX versus 8.0 months for patients treated with FOLFOX alone, hazard ratio 0.80; 95 percent CI: 0.66-0.97; p=0.02) in the first-line treatment of patients with wild-type KRAS mCRC.  
  • Although numerically greater (23.9 months versus 19.7 months, hazard ratio 0.83; 95 percent CI: 0.67-1.02), the improvement in overall survival (OS) (secondary endpoint) in the Vectibix arm did not achieve statistical significance (p=0.072) in the same patient population.
  • Importantly, in patients with tumors harb
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