The clinical performance of the kit was determined in the BEACON CRC Study. This was a three-arm, multicenter, randomized, open-label, Phase 3 study of encorafenib + cetuximab plus (triplet arm) or minus (doublet arm) binimetinib versus irinotecan/cetuximab or infusional 5-fluorouracil/folinic acid/irinotecan/cetuximab (control arm) in patients with BRAF V600E mutant metastatic CRC.
The study comprised 665 patients (224 triplet arm; 220 doublet arm; 221 control arm). Study endpoints included overall survival (OS) and overall response rate (ORR) by BICR (Blinded Independent Central Review) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
The study demonstrated a statistically significant clinical improvement in OS and confirmed ORR by BICR for the doublet arm versus the control arm, with a 40% reduction in risk of death observed with the doublet arm compared to the control arm (HR 0.60, 95% CI: 0.45, 0.79).
Therefore, there is a clear clinical benefit to determining BRAF mutation status when determining patient eligibility for treatment with encorafenib + cetuximab.