Illustration About COLUMBUS

ABOUT COLUMBUS

The COLUMBUS trial was a randomised, Phase 3, multicentre, open-label, active-controlled study^3,4,5,7,11

COLUMBUS study design

AJCC, American Joint Committee on Cancer; BID, twice daily; DoR, duration of response; ECOG PS, Eastern Cooperative Oncology Group Performance Status; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; QD, once daily; QoL, quality of life.

^aFor a full list of inclusion and exclusion criteria, please refer to the Summaries of Product Characteristics.^1,2 ^bAll secondary endpoints are descriptive in nature.

Explore COLUMBUS efficacy results on the efficacy page

LEARN MORE ABOUT COLUMBUS EFFICACY RESULTS

BRAFTOVI^® + MEKTOVI^® was studied in a broad range of patients^11,12

95% of patients in COLUMBUS were treatment naïve for metastatic disease⁴

Select baseline characteristics⁴	BRAFTOVI^® (450 mg) + MEKTOVI^® (45 mg)^a n=192	vemurafenib (960 mg) n=191
Median age (range), years	57 (20–89)	56 (21–82)
ECOG PS 0, %	71	73
LDH ≥ULN, %	29	27
BRAF^V600E/K mutation status, %	89/11	88/12
Tumour stage at study entry, %
IIIB/IIIC	5	6
IVM1a	14	13
IVM1b	18	16
IVM1c	64	65
Number of organs involved, %
1	24	24
2	30	31
≥3	45	46
Previous immunotherapy in advanced or metastatic setting, %
Ipilimumab	3	3
Anti-PD1 or anti-PD-L1	1	0
Interferons or interleukins	2	3

BID, twice daily; ECOG PS, Eastern Cooperative Oncology Group Performance Status; LDH, lactate dehydrogenase; PD-1, programmed cell death protein 1; PD-L1, programmed cell death ligand 1; QD, once daily; ULN, upper limit of normal. ^aDosing regimen for the combination was BRAFTOVI 450 mg QD + MEKTOVI 45 mg BID and BRAFTOVI 300 mg QD^.4

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 European Summaries of Product Characteristics of BRAFTOVI® and MEKTOVI®. 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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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

REFERENCES

1. BRAFTOVI^® Summary of Product Characteristics. Pierre Fabre Médicament.
2. MEKTOVI^® Summary of Product Characteristics. Pierre Fabre Médicament.
3. Dummer R, et Al. COLUMBUS 5-Year Update: A randomized, open-label, phase III trial of encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAFV600–mutant melanoma. J. Clin. Oncol. (2022). DOI: 10.1200/JCO.21.026595-year publication.
4. Dummer R, Ascierto PA, Gogas HJ et al. Overall survival in patients with BRAF-mutant melanoma receiving encorafenib plus binimetinib versus vemurafenib or encorafenib (COLUMBUS): a multicentre, open-label, randomised, Phase 3 trial. Lancet Oncol 2018;19(10):1315–1327.
5. Ascierto PA, Dummer R, Gogas HJ et al. Update on tolerability and overall survival in COLUMBUS: landmark analysis of a randomised Phase 3 trial of encorafenib plus binimetinib vs vemurafenib or encorafenib in patients with BRAF^V600-mutant melanoma. Eur J Cancer 2020;126:33–44.
6. Gogas HJ, Flaherty KT, Dummer R et al. Adverse events associated with encorafenib plus binimetinib in the COLUMBUS study: incidence, course and management. Eur J Cancer 2019;119:97–106.
7. Gogas HJ, Dummer R, Ascierto PA et al. Quality of life in patients with BRAF-mutant melanoma receiving the combination encorafenib plus binimetinib: results from a multicentre, open-label, randomised, Phase III study (COLUMBUS). Eur J Cancer 2021;152:116–128.
8. Musoro JZ, Bottomley A, Coens C et al. Interpreting European Organisation for Research and Treatment for Cancer Quality of life Questionnaire core 30 scores as minimally importantly different for patients with malignant melanoma. Eur J Cancer 2021;104:169–181.
9. Trojaniello C, Festino L, Vanella V et al. Encorafenib in combination with binimetinib for unresectable metastatic melanoma with BRAF mutation. Expert Rev Clin Pharmacol 2019;12(3):259–266.
10. Heinzerling L, Elgentler TK, Fluck M et al. Tolerability of BRAF/MEK inhibitor combinations: adverse event evaluation and management. ESMO Open 2019;4(3):e000491.
11. Dummer R, Ascierto PA, Gogas HJ et al. Encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF-mutant melanoma (COLUMBUS): a multicentre, open-label, randomised Phase 3 trial. Lancet Oncol 2018;19(5):603–615.
12. Lebbe C, Lorigan P, Ascierto PA et al. Treatment patterns and outcomes among patients diagnosed with unresectable stage III or IV melanoma in Europe: a retrospective, longitudinal survey (MELODY study). Eur J Cancer 2012;48(17):3205–3214.
13. Gogas HJ, et al. Updated Quality of Life (QoL) of encorafenib + binimetinib (COMBO450) versus (vs) vemurafenib (VEM) from COLUMBUS Part 1 Phase III study in BRAF-mutant melanoma. Presented at the 16th International Congress of the Society for Melanoma Research (SMR). November 20–23, 2019, Salt Lake City, Utah. USA.

This is an international website for BRAFTOVI^®+MEKTOVI^®. IMPORTANT: the information on this website is based on the European 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.

HQ-MEK-09-23-2300001 Last update: September 2023

Pierre Fabre

BRAFTOVI® is a trademark of Array BioPharma Inc., a wholly owned subsidiary of Pfizer Inc. MEKTOVI® is a trademark of Array BioPharma Inc. a wholly owned subsidiary of Pfizer Inc. © 2023, Pierre Fabre all rights reserved