- Triplet therapy with binimetinib, encorafenib, and cetuximab was well-tolerated and achieved a median OS of 15.3 months in patients with metastatic BRAF V600E-positive colorectal cancer (CRC) who had failed 1 or 2 prior therapies.
Why this matters
- Typical survival is 4-6 months in patients who have failed first-line therapies.
- Authors write that the combination could become standard of care if supported in the randomized portion of the BEACON trial.
- Safety lead-in to the phase 3 randomized, open-label BEACON trial.
- Patients who had failed 1-2 previous regimens received binimetinib, encorafenib, and cetuximab (n=30).
- Funding: Array BioPharma, Merck KGaA, Pierre Fabre Medicament, Ono Pharmaceutical.
- 5 patients experienced dose-limiting toxicities.
- Toxicities: 2 grade 1 (6.7%), 7 grade 2 (23.3%), 16 grade 3 (53.3%), 5 grade 4 events (16.7%).
- Treatment-emergent adverse events (TEAEs) included diarrhea (77%), dermatitis acneiform (67%), fatigue (63%), and nausea (63%).
- Grade 3/4 TEAEs fatigue (13%), anemia (10%), increased aspartate transaminase (10%), increased creatine phosphokinase (10%), and urinary tract infection (10%).
- In 29 patients with confirmed BRAF V600E-mutant tumors:
- Centrally assessed overall response rate, 41% (95% CI, 23.5%-61.1%).
- Median centrally assessed PFS, 5.5 (95% CI, 4.2-9.3) months.
- Median OS, 15.3 (median follow-up, 18.2) months.
- Small patient population.