1. Home
  2. EFFICACY
Image
Efficacy illustration

EFFICACY

Explore COLUMBUS study design and patients characteristics

LEARN MORE ABOUT COLUMBUS

Explore BRAFTOVI® + MEKTOVI® long-term efficacy data

Collapse all Expand all

PFS rate by central review %a,b,c

Image
PFS

 

        More than 1 in 5 patients remained progression-free at 7 years 

with BRAFTOVI® + MEKTOVI® (21%) 3,f

 
 

a Curve adapted from SmPCs, Schadendorf et al. 2024, and Dummer et al. 2022.1-4 b PFS (central review) was the primary endpoint of the COLUMBUS study.5 In the initial analysis (cut-off date May 2016), BRAFTOVI® + MEKTOVI® achieved a median PFS of 14.9 months vs 7.3 months for vemurafenib (HR=0.54 [95% CI: 0.41–0.71] nominal p<0.0001).5 c Final analysis. Cut-off date: March 2023.1,2 d In progression or death.5 e Nominal p-value. f Cut-off date: January 2023.3 Results at 7 years are from a descriptive post-hoc analysis and should be interpreted in the context of this limitation. 

CI, confidence interval; HR, hazard ratio; PFS, progression-free survival; LDH, lactate dehydrogenase.

Overall Survival rate %a,b,c 

Image
OS

 

More than 1 in 4 patients were still alive at 7 years 

with BRAFTOVI® + MEKTOVI® (27%)3,f



a Curve adapted from SmPCs and Schadendorf et al. 2024.1-3 b OS was a secondary endpoint of the COLUMBUS study with a nominal p value.6 c Cut-off date: March 2023.1,2 d In death.6 e Nominal p-value. f Cut-off date: January 2023.3 Results at 7 years are from a descriptive post-hoc analysis and should be interpreted in the context of this limitation.

CI, confidence interval; HR, hazard ratio; LDH, lactate dehydrogenase; OS, overall survival.

ORR by central reviewa,b,1,2

Image
Achieve improved disease control, tumour shrinkage and duration of response

More than 9 in 10 patients achieved disease control 

with BRAFTOVI® + MEKTOVI® (92% vs 81% for vemurafenib)c,d,e,1,2

Median DoR by central reviewa,b,1,2

Image
DoR final

      

BRAFTOVI® + MEKTOVI® extended the median duration of response 

by more than 6 months vs vemurafenibc,d,1,2

 

 

The 7-year analysis is post hoc and descriptive. 

a Adapted from SmPCs.1,2 b ORR and DoR were secondary endpoints of the COLUMBUS study.6 c Final analysis. Cut-off date: March 2023. d By central review.1,2 e Disease control rate = CR+PR+SD+Non-CR/Non-PD.1,2 

CI, confidence interval; CR, complete response; DoR, duration of response; ORR, overall response rate; PR, partial response; SD, stable disease

 

Image

 

BRAFTOVI® + MEKTOVI® achieved better OS outcomes across 

various patient subgroups vs vemurafeniba,7

 

a Cut-off date: January 2023. Median follow-up of 97.4 months. Results at 7 years are from a descriptive post-hoc analysis and should be interpreted in the context of this limitation.3 b Lower limit of confidence interval is <0.25. 

CI, confidence interval; HR, hazard ratio; LDH, lactate dehydrogenase; NE, not evaluable; OS, overall survival; ULN, upper limit of normal

For complete information, please refer to the Summaries of Product Characteristics.

EU healthcare professionals​

This is an international website for BRAFTOVI® + MEKTOVI® dedicated to EU healthcare professionals (outside the UK and ROI). ​​

IMPORTANT: the information on this website is based on the EU Summaries 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.

I certify that: 

I am a Healthcare Professional in the EU (outside the UK and ROI) and I have read the information above​.

Patients/ Non EU healthcare professionals​

This is an international website for BRAFTOVI® + MEKTOVI® dedicated to EU healthcare professionals (outside the UK and ROI).

I am a patient or a healthcare professional outside the EU.

https://www.pierre-fabre.com/en