Encorafenib in Combination With Cetuximab for BRAFV600E-Mutant Metastatic Colorectal Cancer: A Pooled Analysis of European Observational Studies

OBJECTIVES: Encorafenib plus cetuximab (EC) has become the standard of care for patients with BRAF^V600E-mutant metastatic colorectal cancer (mCRC) after prior systemic therapy. Several real-world studies have collected data in this relatively rare patient population; therefore, a pooled analysis approach was designed to better understand the disease characteristics, treatment strategy in these patients and also the use, effectiveness, and safety of EC for BRAF^V600E-mutant mCRC in Europe.

METHODS: This is a retrospective, longitudinal, pooled analysis of data from real-world observational studies conducted across Europe between 2020–2024. Adult patients (aged ≥18 years) who received an encorafenib-based regimen for BRAF^V600E-mutant mCRC in each study will be included in the present analysis. Data collected from the date of encorafenib-based treatment initiation until the end of the observation period in each study (end of follow-up or death, whichever occurred first) will be pooled.

RESULTS: The pooled database will compile data from >1,000 patients across several studies, including BERING CRC (Austria/Germany/Switzerland; NCT04673955), BRAFGOIM (Italy), B-REAL (France), BRIDGE (Netherlands), CATAMARAN (Netherlands), CONFIDENCE (Spain), Italian GONO cohort (Italy), mCRC Portugal, and others as data becomes available. The primary objective is to describe the patient demographics and disease characteristics of those who receive encorafenib-based therapy for BRAF^V600E-mutant mCRC in European clinical practice. Secondary objectives are to evaluate treatment patterns (dose, duration, prior and subsequent treatments), effectiveness outcomes (response rates, progression-free survival [PFS], overall survival [OS]), and safety outcomes (adverse events [AEs]) associated with encorafenib-based therapy; identify prognostic factors associated with PFS, OS, and AEs; and describe real-world BRAF testing practices. The study methodology (e.g., data mapping, coding) and characteristics of the final pooled dataset will be presented at the meeting.

CONCLUSIONS: Using a large real-world dataset, the first stage of this analysis will describe patient characteristics and prognostic factors for those who receive EC combination therapy for BRAF^V600E-mutant mCRC across Europe.