BEACON CRC Study design

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BEACON CRC: The first phase 3 trial to exclusively study patients with BRAFV600E-mutant mCRC

The largest global, randomised, multicentre, open-label clinical trial of 665 patients with previously treated mCRC with a BRAFV600E mutation1,3,11

 

Randomisation 1:1:1 N=665, BRAFTOVI (300 mg QD) + cetuximab (n=220), BRAFTOVI (300 mg QD) + binimetinib + cetuximab (n=224), Control arm: FOLFIRI + cetuximab or irinotecan + cetuximab (n=221)

 

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

Efficacy outcome measures1

  • Overall survivala
  • Overall response ratea,b

Other measures1,3

  • Progression-free survivala,b
  • Duration of responseb
  • Safetya

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 BRAFV600E- 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.

EU HealthCare Professionals​

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IMPORTANT: the information on this website is based on the European Summary of Product Characteristics. Prescribing Information and indication may vary per country. You must refer to your country prescribing information. Please be aware we do not take responsibility for accessing such information which may not comply with the regulation or usage in your country.

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