BEACON CRC Study design

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BEACON CRC: The only 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 is not approved for the treatment of patients with BRAFV600E-mutant mCRC in any country.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.

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