Overall Response Rate

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BRAFTOVI + cetuximab demonstrated a significantly higher overall response rate vs control arm*

BRAFTOVI + cetuximab improved response rates in both analyses1,a

*Irinotecan based treatment regimen

Overall response rate per updated post-hoc analysis (median follow-up 12.8 months)13

19,5% ORR (95% CI: 14,5-25%) - 3,2% CR - 16,4% PR - BRAFTOVI + cetuximab (n=220). VS 1,8% ORR (95% CI: 0,5-4,6) 0%CR 1,8% PR FOLFIRI + cetuximab or irinotecan + cetuximab (n=221=

Overall response rate per primary analysis3

  • 20.4% (95% CI: 13.4-29.0) with BRAFTOVI + cetuximab (n=113) vs 1.9% (95% CI: 0.2-6.6) with FOLFIRI + cetuximab or irinotecan + cetuximab (n=107) (P<0.0001)
    • CR rate was 5.3% with BRAFTOVI + cetuximab vs 0% with FOLFIRI + cetuximab or irinotecan + cetuximab
    • PR rate was 15.0% with BRAFTOVI + cetuximab vs 1.9% with FOLFIRI + cetuximab or irinotecan + cetuximab
  • Responses in the primary analysis were based on the first 331 randomised patients, which included a total of 220 patients in both the BRAFTOVI + cetuximab arm (n=113) and the FOLFIRI + cetuximab or irinotecan + cetuximab arm (n=107)

aORR was assessed by BIRC. Tumour assessments were performed according to RECIST v1.1.1,3 CR, complete response; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumors.

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