Indication and Limitation of Use

Vectibix® is indicated for the treatment of patients with wild-type KRAS (exon 2 in codons 12 or 13) metastatic colorectal cancer (mCRC) as determined by an FDA-approved test for this use: as first-line therapy in combination… read more

Vectibix® is indicated for the treatment of patients with wild-type KRAS (exon 2 in codons 12 or 13)… read more

Vectibix® is indicated for the treatment of patients with wild-type KRAS (exon 2 in codons 12 or 13) metastatic colorectal cancer (mCRC) as determined by an FDA-approved test… read more

Vectibix® is indicated for the treatment of patients with wild-type KRAS (exon 2 in codons 12 or 13) metastatic colorectal cancer (mCRC) as determined by an FDA-approved test for this use: as first-line therapy in combination with FOLFOX, as monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy.

Vectibix® is not indicated for the treatment of patients with RAS-mutant mCRC or for whom RAS mutation status is unknown.

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In the exploratory analysis of overall survival (OS), Vectibix® improved median OS in the first line by 4.4 months versus FOLFOX alone in wild-type (WT) KRAS* metastatic colorectal cancer (mCRC)1

The PRIME clinical study design: a phase 3, open-label, randomized, multicenter study1,2

Primary endpoint1,2

  • Progression-free survival (PFS)2

Key secondary endpoints2

  • Overall survival (OS)2
  • Objective response rate (ORR)2
  • Safety2

Patient characteristics2

  • Patients aged ≥ 18 years2
  • Previously untreated mCRC2
  • ECOG performance status 0-22
  • Median age 62 years2
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*Exon 2 in codons 12 or 13. 1

ECOG = Eastern Cooperative Oncology Group; MT = mutant type; Q2W = every two weeks;
PRIME = The Panitumumab Randomized Trial In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy.


Primary analysis of progression-free survival

Vectibix® + FOLFOX significantly improved progression-free survival (PFS) vs. FOLFOX alone
in patients with wild-type (WT) KRAS metastatic colorectal cancer (mCRC) (P = 0.02)1,2

  • The primary analysis was conducted when survival events occured in > 50% of patients with WT KRAS exon 22
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PRIME results: exploratory analysis of overall survival (OS)

Vectibix® + FOLFOX increased median overall survival (OS) 4.4 months versus FOLFOX alone in patients with wild-type (WT) KRAS metastatic colorectal cancer (mCRC)1

  • This analysis was conducted when patient survival events occured in > 80% of patients with WT KRAS mCRC to estimate the treatment effect of Vectibix® + FOLFOX vs. FOLFOX alone OS1,2
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  • Results were based on 82% of OS events in WT KRAS mCRC (n = 656)1
  • There were no overall survival (OS) or progression-free survival (PFS) benefits in Vectibix®-treated patients with mutant KRAS metastatic colorectal cancer1
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