BRAF V600E-mutant metastatic colorectal cancer is a molecularly defined aggressive subtype of mCRC associated with poorer prognosis and distinct treatment strategies compared with unselected mCRC. It represents a clinically important biomarker-defined population for targeted therapy combinations.
Phase 3 BREAKWATER found encorafenib plus cetuximab plus FOLFIRI improved PFS and response in first-line BRAF V600E-mutant metastatic colorectal cancer. OS data remain immature.
Pfizer reported positive Phase 3 trial results for BRAFTOVI combination therapy in metastatic colorectal cancer and received FDA Priority Review for HYMPAVZI expansion to hemophilia patients including children.
Phase 3 BREAKWATER trial shows encorafenib plus cetuximab and chemotherapy achieved 30.3 months median overall survival versus 15.1 months with standard therapy in previously untreated BRAF V600E-mutant metastatic colorectal cancer.
Pfizer announced positive results from Cohort 3 of the Phase 3 BREAKWATER trial, showing BRAFTOVI combined with cetuximab and FOLFIRI significantly improved progression-free survival in previously untreated BRAF V600E-mutant metastatic colorectal cancer patients.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07007689 |
A Multi-omics Study of BRAF V600E Mutant Colorectal Cancer |
NOT_YET_RECRUITING | |
| NCT03693170 |
Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal Cancer |
COMPLETED | PHASE2 |
| NCT02928224 |
Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer |
COMPLETED | PHASE3 |
