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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

oring activating KRAS mutations, PFS was significantly inferior in the Vectibix arm. For patients with mutant KRAS tumors, median PFS was 7.3 months with Vectibix in combination with FOLFOX versus 8.8 months with FOLFOX alone (hazard ratio 1.29; 95 percent CI: 1.04-1.62; p=0.02).
  • These data confirm previous findings when oxaliplatin-based chemotherapy and an anti-EGFR antibody were combined in patients bearing tumors with activating KRAS mutations.
  • The response rate of Vectibix plus chemotherapy was higher than chemotherapy alone in the wild-type KRAS patient population as measured by blinded central review (55 percent versus 48 percent in the FOLFOX only arm).
  • Tumor KRAS status was ascertained in 93 percent of the 1,183 patients enrolled in the PRIME '203' trial, the highest number ever prospectively reported for a first-line trial.

  • "The outcome of this high quality trial demonstrated that Vectibix, which was administered every two weeks, improved progression-free survival as a first-line metastatic colorectal cancer treatment in a selected patient population," said Jean Yves-Douillard, M.D., Ph.D., director Clinical and Translational Research, Medical Oncology Branch, Centre R Gauducheau, France and PRIME '203' trial lead investigator and study author.

    '181' Results in Second-Line mCRC Demonstrate Vectibix Combined with Chemotherapy (FOLFIRI) Helped Patients with Wild-type KRAS mCRC Live Longer Without their Disease Worsening (PFS)

  • Results of the '181' trial showed that the addition of Vectibix to FOLFIRI (an irinotecan-based chemotherapy) significantly improved PFS (co-primary endpoint) (median 5.9 months for Vectibix plus FOLFIRI versus 3.9 months for patients treated with FOLFIRI alone, hazard ratio 0.73; 95 percent CI: 0.59-0.90; p=0.004) in the second-line treatment of patients with wild-type KRAS mCRC.
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  • SOURCE Amgen
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