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Efficacy illustration

EFFICACY

 

Explore BRAFTOVI® + MEKTOVI® long-term efficacy data

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PFS rate by central review %a,b,c

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PFS

 

Almost 1 in 4 patients remained progression free at 5 years
with BRAFTOVI + MEKTOVI (23%)3

 

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:041-0.71] p<0.0001)11
 

Results at 5 years are a descriptive post hoc analysis. They should be interpreted in the context of this limitation. CI, confidence interval; HR, hazard ratio; PFS, progression-free survival. 
aAdapted from Dummer et al. 20223.  bCut-off date: September 2020. Median follow-up of 40.8 months3.  cPFS (central review) was the primary endpoint of the COLUMBUS study3. dIn progression or death3.

Overall Survival rate %a,b,c 

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OS

 

In the BRAFTOVI + MEKTOVI arm, more than 1 in 3 patients were still alive at 5 years (35%)3

 

In the initial analysis (cut-off date November 2017), BRAFTOVI + MEKTOVI achieved a median OS of 33.6 months vs 16.9 months for vemurafenib (HR =0.61 [95% CI: 0.47-0.79] p<0.0001)4

Results at 5 years are a descriptive post hoc analysis. They should be interpreted in the context of this limitation. CI, confidence interval; HR, hazard ratio; OS, overall survival.
aAdapted from Dummer et al. 20223 bCut-off date: September 2020. Median follow-up of 70.4 months3 cOS was a secondary endpoint of the COLUMBUS study4 dIn death3. 

ORR by central reviewa,b,e,3

Cut-off date September 2020

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ORR by central review

Almost 2 out of 3 patients responded to
BRAFTOVI + MEKTOVI3

ORR by local reviewc,d,e,5

Cut-off date November 2018

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ORR by local review

More than 3 out of 4 patients responded to
BRAFTOVI + MEKTOVI5

 

Median DoR by central reviewa,b,3

Cut-off date September 2020

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DOR by central review

BRAFTOVI + MEKTOVI extended the median duration
of response by more than 6 months vs vemurafenib3

 

In the initial analysis (cut-off date May 2016), more patients in BRAFTOVI + MEKTOVI arm attained an overall response compared with those in vemurafenib arm:
 63% (95% CI: 56– 70) vs 40% (95% CI: 33– 48) by  central review and 75% (95% CI: 68– 81) vs 49% (95% CI: 42– 57) by local review. Median duration of response was 16.6 months (95% CI 12.2– 20.4) in BRAFTOVI + MEKTOVI arm vs 12.3 months (95% CI 6.9– 16.9) in vemurafenib arm11
 

Results at 5 years are a descriptive post hoc analysis. They should be interpreted in the context of this limitation. CI, confidence interval; CR, complete response; DoR, duration of response; ORR, overall response rate; PR, partial response.
aAdapted from Dummer et al. 20223 bBy central review3 cAdapted from Ascierto et al. 20203  dBy local review5 eORR and DoR were secondary endpoints of the COLUMBUS study4. fDisease control rate = ORR (%) +  SD (%).

PFS according to baseline LDH levelsa,b 

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PFS LDH levels

OS according to baseline LDH levelsa,b 

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OS LDH levels

 

Almost 4X longer median PFS in patients with
normal LDH vs high LDH with BRAFTOVI + MEKTOVI3

More than 4X longer median OS in patients with
normal LDH vs high LDH with BRAFTOVI + MEKTOVI3


OS outcomes in patients subgroupsa,b

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Forest Plot subgroups

Achieve better OS outcomes across various patient subgroups3 

Results at 5 years are a descriptive post hoc analysis. They should be interpreted in the context of this limitation. AJCC, American Joint Committee on Cancer; CI, confidence interval; ECOG, Eastern Cooperative Oncology Group; HR, hazard ratio; LDH, lactate dehydrogenase; ULN, upper limit of normal; PFS, progression-free survival; OS, overall survival.

aAdapted from Dummer et al. 20223 bCut-off date: September 20203.

Time to definitive 10% deterioration in FACT-M QoL scorea,b,c

Cut-off date: November 2018

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QoL Fact-M

 

 Allow patients to maintain their QoL for longer with BRAFTOVI + MEKTOVI vs vemurafenib7,13


Change in health-related QoL from baseline over timea,b,c

Cut-off date: November 2018

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QoL EORTC

BRAFTOVI + MEKTOVI brings a meaningful difference to your patients’ quality of life vs vemurafenib7

CI, confidence interval; EORTC QLQ, European Organisation for Research and Treatment of Cancer core quality of life questionnaire; FACT-M, Functional Assessment of Cancer Therapy-Melanoma; HR, hazard ratio; MCID, minimal clinically important difference; MMRM, mixed model repeated measures; QoL, quality of life; SEM, standard error for the mean.
aAdapted from Gogas et al. 20217 bCut-off date: November 20187 cQoL was a secondary endpoint of the COLUMBUS study7.

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

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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.

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