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🌱 來自: Metastatic Colon Cancer

BEACON

Encorafenib, Binimetinib, and Cetuximab in BRAF V600E-Mutated Colorectal Cancer | NEJM

Encorafenib, Binimetinib, and Cetuximab in Patients with BRAF V600E-Mutant Metastatic Colorectal Cancer: Updated Overall Survival Results from a Randomized, Open-Label, Phase 3 Trial (BEACON CRC)

1. Design
   • Open-label, Phase 3 trial
   • Multi-center
   • Randomized
   • Three treatment groups:
     • Triplet-therapy group: encorafenib, binimetinib, and cetuximab
     • Doublet-therapy group: encorafenib and cetuximab
     • Control group: investigator’s choice of cetuximab and irinotecan or cetuximab and FOLFIRI
2. Number of patients: 665
3. Patients characteristics:
   • Metastatic colorectal cancer with BRAF V600E mutation
   • Disease progression after one or two previous regimens
4. Agent:
   • Encorafenib
   • Binimetinib
   • Cetuximab
5. Treatment line: Second or third-line therapy
6. Trial Name/NCT Number: BEACON CRC ClinicalTrials.gov number - NCT02928224
7. Comparison of two groups:

Endpoint	Triplet-therapy group	Control group
Overall survival	Median of 9.0 months (hazard ratio for death, 0.52; 95% CI, 0.39 to 0.70; P<0.001)	Median of 5.4 months
Confirmed response rate	26% (95% CI, 18 to 35)	2% (95% CI, 0 to 7)
Overall survival in doublet-therapy group vs. control group	Median of 8.4 months (hazard ratio for death vs. control, 0.60; 95% CI, 0.45 to 0.79; P<0.001)	Not reported

8. Other findings:
   • Adverse events of grade 3 or higher occurred in 58% of patients in the triplet-therapy group, in 50% in the doublet-therapy group, and in 61% in the control group.
9. Summary: The BEACON CRC trial evaluated the efficacy and safety of encorafenib, binimetinib, and cetuximab in patients with metastatic colorectal cancer with BRAF V600E mutation. The triplet-therapy group showed a significantly longer median overall survival and a higher confirmed response rate compared to the control group. The doublet-therapy group also showed a longer median overall survival compared to the control group. Adverse events of grade 3 or higher were more common in the control group. These findings suggest that encorafenib, binimetinib, and cetuximab could be a valuable treatment option for patients with metastatic colorectal cancer with BRAF V600E mutation.