Overall Response Rate

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

BRAFTOVI + cetuximab improved response rates in both analyses^1,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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Overall Survival

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Tumor Response

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Progression Free Survival

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This is an international website for BRAFTOVI ®. IMPORTANT: the information on this website is based on the European Summary of Product Characteristics . Prescribing Information and indication may vary per country. You must refer to your country prescribing information. Please be aware we do not take responsibility for accessing such information which may not comply with the regulation or usage in your country