BEACON CRC Study design

BEACON CRC: The first phase 3 trial to exclusively study patients with BRAF^V600E-mutant mCRC

The largest global, randomised, multicentre, open-label clinical trial of 665 patients with previously treated mCRC with a BRAF^V600E mutation^1,3,11

Randomisation was stratified by ECOG PS, prior use of irinotecan, and cetuximab source.¹

Efficacy outcome measures¹

• Overall survival^a
• Overall response rate^a,b

Other measures^1,3

• Progression-free survival^a,b
• Duration of response^b
• Safety^a

The BEACON CRC trial was a positive study, and both primary end points (OS and ORR for BRAFTOVI + binimetinib + cetuximab vs control arm) were met. Median OS was 9.0 months (95% CI: 8.0-11.4) with BRAFTOVI + binimetinib + cetuximab (n=224) vs 5.4 months (95% CI: 4.8-6.6) with control arm (n=221) (HR=0.52 [95% CI: 0.39-0.70], P<0.001), per primary analysis. ORR was 26% (95% CI: 18-35) with BRAFTOVI + binimetinib + cetuximab (n=111) vs 2% (95% CI: <1-7) with control arm (n=107) (P<0.001), per primary analysis. The data for BRAFTOVI + binimetinib + cetuximab are presented in the exclusive interest of the integrity of the data of BEACON CRC. BRAFTOVI + binimetinib + cetuximab may not be approved for the treatment of patients with BRAF^V600E- mutant mCRC in all countries. Please refer to your local SmPc.^.1,3

Cetuximab: initial dose of 400 mg/m2 followed by 250 mg/m2 weekly.^3,8 
Binimetinib: 45 mg twice daily.³ 
FA: 400 mg/m2 on Days 1 and 15.^3,8 
5-FU: initial dose of 400 mg/m2 followed by 1200 mg/m2/day for 2 days (total of 2400 mg/m2 over 46-48 hours) on Days 1 and 15.^3,8 
Irinotecan: 180 mg/m2 on Days 1 and 15.^3,8

Treatment was administered until disease progression, unacceptable toxic effects, withdrawal of consent, initiation of subsequent anticancer therapy, or death.³

^aBRAFTOVI + cetuximab vs FOLFIRI + cetuximab or irinotecan + cetuximab.^1,3 
bORR, PFS, and DoR were assessed by BIRC.^1,3 
The cut-off dates were February 2019 for the primary analysis and August 2019 for the updated analysis. The primary analysis of the Phase 3 data for ORR was based on the first 331 randomised patients. Other Phase 3 efficacy analyses included all 665 randomised patients^.1 

BIRC, blinded independent review committee; CI, confidence interval; DoR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; FA, folinic acid; FOLFIRI, 5-fluorouracil bolus followed by continuous infusion + leucovorin + irinotecan; HR, hazard ratio; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; QD, twice daily; 5-FU, 5-fluorouracil.