BEACON CRC (doublet regimen)
Trial question
What is the role of a combination of encorafenib and cetuximab in patients with metastatic CRC with BRAF V600E mutation?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
53.0% female
47.0% male
N = 441
441 patients (232 female, 209 male).
Inclusion criteria: patients with BRAF V600E-mutated metastatic CRC who had disease progression after 1 or 2 previous regimens.
Key exclusion criteria: prior treatment with any RAF inhibitor, MEK inhibitor, or other EGFR inhibitors; symptomatic brain metastasis or leptomeningeal disease; acute or chronic pancreatitis; uncontrolled BP despite medical treatment.
Interventions
N=220 doublet regimen (combination of encorafenib 300 mg daily and cetuximab 250-400 mg/m² weekly).
N=221 control (investigators choice of either cetuximab and irinotecan or cetuximab and folinic acid, fluorouracil, and irinotecan).
Primary outcome
Overall survival
8.4 months
5.4 months
8.4 months
6.3 months
4.2 months
2.1 months
0.0 months
Doublet
regimen
Control
Significant
increase ▲
Significant increase in overall survival (8.4 months vs. 5.4 months; HR 1.67, 95% CI 1.27 to 2.22).
Secondary outcomes
Significant increase in objective response rate (20% vs. 2%; AD 18%, 95% CI 7.32 to 28.68).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients with BRAF V600E-mutated metastatic CRC who had disease progression after 1 or 2 previous regimens, doublet regimen were superior to control with respect to overall survival.
Reference
Scott Kopetz, Axel Grothey, Rona Yaeger et al. Encorafenib, Binimetinib, and Cetuximab in BRAF V600E-Mutated Colorectal Cancer. N Engl J Med. 2019 Oct 24;381(17):1632-1643.
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