Use of Encorafenib + Cetuximab EC in Patients With BRAF V600E–Mutant Metastatic Colorectal Cancer (mCRC) in Real-World Settings: Data Visualization From a Pooled Dataset of European Observational Studies
Author(s)
Chiara Cremolini, MD, PhD1, Julien Taieb, MD, PhD2, Erika Martinelli, MD, PhD3, Ana Fernandez Montes, MD, PhD4, Elena Elez Fernandez, MD, PhD5, Jeanine Roodhart, MD, PhD6, Hanane Attar, MD, PhD7, Farida Beghdad, MSc8, Kalaivani Ruhier, MSc9, Florence CARRERE, MSc9, Sebastian Stintzing, MD, PhD10.
1Department of Translational Research and New Technologies, Pisa, Italy, 2Gastroenterology and Digestive Oncology Department, HEGP – Hopital Europeen Georges-Pompidou – AP-HP, Paris, France, 3Department of Precision Medicine, Universita degli Studi della Campania Luigi Vanvitelli, Napoli, Italy, 4Dept. Medical Oncology, Complexo Hospitalario Universitario de Ourense, Ourense, Spain, 5Department of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain, 6Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands, 7Medical Affairs, Pierre Fabre Oncology, Boulogne Billancourt, France, 8Real-World Evidence and Data, Pierre Fabre Oncology, Boulogne, France, 9Biometry, Institut de Recherche Pierre Fabre, Boulogne-Billancourt, France, 10Hematology, Oncology, and Cancer Immunology (CCM) Dept, Charité – Universitatsmedizin Berlin, Berlin, Germany.
1Department of Translational Research and New Technologies, Pisa, Italy, 2Gastroenterology and Digestive Oncology Department, HEGP – Hopital Europeen Georges-Pompidou – AP-HP, Paris, France, 3Department of Precision Medicine, Universita degli Studi della Campania Luigi Vanvitelli, Napoli, Italy, 4Dept. Medical Oncology, Complexo Hospitalario Universitario de Ourense, Ourense, Spain, 5Department of Medical Oncology, Vall d’Hebron University Hospital, Barcelona, Spain, 6Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands, 7Medical Affairs, Pierre Fabre Oncology, Boulogne Billancourt, France, 8Real-World Evidence and Data, Pierre Fabre Oncology, Boulogne, France, 9Biometry, Institut de Recherche Pierre Fabre, Boulogne-Billancourt, France, 10Hematology, Oncology, and Cancer Immunology (CCM) Dept, Charité – Universitatsmedizin Berlin, Berlin, Germany.
OBJECTIVES: This study aimed at describing characteristics, treatment patterns, effectiveness and safety of patients (pts) treated with Encorafenib + cetuximab (EC) for BRAFV600E-mutant metastatic colorectal cancer (mCRC) in real-life settings. Techniques for data visualization were used to optimize visual representation of the data.
METHODS: This retrospective, longitudinal study pooling data from 5 European observational real-world studies was conducted between 2020-2024 in adult pts with BRAFV600E mutant mCRC treated with EC. Pts clinical characteristics, treatment sequences (prior and subsequent EC treatments), effectiveness and safety outcomes were analysed using descriptive analysis and data visualization techniques (including Sankey diagram, Time sequence analysis using K-clustering (TAK)).
RESULTS: A total of 709 pts were included, with a median follow-up time (Q1; Q3) of 6.9 (3.9 ;11.6) months. Median age at baseline was 65 (57; 72) years and 54.4% (N=385) were females. 36.6% of pts (N=259) had 1 metastatic site, 32.4% (N=230) had 2 and 30.9% (N=219) had 3 or more. EC combination was given after prior systemic treatment (relapse during or after adjuvant treatment) in 4.7% (N=33) of pts, 66.1% (N=469) in 2nd LoT, 21.3% (N=151) in 3rd LoT and 7.9% (N=56) in 4th LoT and beyond. EC treatment duration was 5.0 (+/-4.62) months in average (+/-sd), with a shorter duration observed in patients with ECOG ≥ 2 (3.2 (+/-2.97) months). After EC in 2ndLoT, the most common subsequent treatment received was FOLFIRI + anti-VEGF (25.9%, N=52). OS rate (%95 CI) at 12 months was 37.4% (33.3%-41.4%). No new safety signals were identified.
CONCLUSIONS: Effectiveness and safety are consistent with phase III results and confirm that EC should be provided as early as possible in the treatment strategy. Data visualization offers an improved overview of treatment sequences.
METHODS: This retrospective, longitudinal study pooling data from 5 European observational real-world studies was conducted between 2020-2024 in adult pts with BRAFV600E mutant mCRC treated with EC. Pts clinical characteristics, treatment sequences (prior and subsequent EC treatments), effectiveness and safety outcomes were analysed using descriptive analysis and data visualization techniques (including Sankey diagram, Time sequence analysis using K-clustering (TAK)).
RESULTS: A total of 709 pts were included, with a median follow-up time (Q1; Q3) of 6.9 (3.9 ;11.6) months. Median age at baseline was 65 (57; 72) years and 54.4% (N=385) were females. 36.6% of pts (N=259) had 1 metastatic site, 32.4% (N=230) had 2 and 30.9% (N=219) had 3 or more. EC combination was given after prior systemic treatment (relapse during or after adjuvant treatment) in 4.7% (N=33) of pts, 66.1% (N=469) in 2nd LoT, 21.3% (N=151) in 3rd LoT and 7.9% (N=56) in 4th LoT and beyond. EC treatment duration was 5.0 (+/-4.62) months in average (+/-sd), with a shorter duration observed in patients with ECOG ≥ 2 (3.2 (+/-2.97) months). After EC in 2ndLoT, the most common subsequent treatment received was FOLFIRI + anti-VEGF (25.9%, N=52). OS rate (%95 CI) at 12 months was 37.4% (33.3%-41.4%). No new safety signals were identified.
CONCLUSIONS: Effectiveness and safety are consistent with phase III results and confirm that EC should be provided as early as possible in the treatment strategy. Data visualization offers an improved overview of treatment sequences.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
CO259
Topic
Clinical Outcomes, Health Service Delivery & Process of Care
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Oncology, Personalized & Precision Medicine