Highlighting BRAFTOVI as a potentially practice-changing treatment option for patients and families facing metastatic colorectal cancer
Pfizer has shared positive topline progression-free (PFS) survival results from Cohort 3, a separate randomised cohort of the BreakWater trial, evaluating BRAFTOVI (encorafenib) in combination with cetuximab (marketed as Erbitux) and Folfiri (fluorouracil, leucovorin, and irinotecan) in patients with previously untreated metastatic colorectal cancer (mCRC) with a BRAF V600E mutation.
The BRAFTOVI regimen demonstrated a statistically significant and clinically meaningful improvement in PFS, a key secondary endpoint, as assessed by blinded independent central review (BICR) compared with Folfiri with or without bevacizumab. Overall survival, a descriptive secondary endpoint, also revealed clinically meaningful prolonged improvement with the BRAFTOVI regimen.
Jeff Legos, chief oncology officer at Pfizer, said, “These results build on the positive objective response rate data we recently shared, providing further evidence of the meaningful benefit this BRAFTOVI-based targeted approach may offer patients with BRAF V600E–mutant metastatic colorectal cancer. The combination of significant responses and now improvement in progression‑free survival underscores the potential of BRAFTOVI as a potentially practice-changing treatment option for patients and families facing this challenging diagnosis.”
The primary endpoint for this BreakWater cohort was objective response rate (ORR) per BICR. Positive ORR results were achieved and presented at the 2026 American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium. At the time of the PFS analysis, the BRAFTOVI combination with cetuximab and Folfiri was consistent with the known profiles of each regimen component, and no new safety signals were observed.
BEAFTOVI in combination with cetuximab and Folfiri is an investigational regimen and is not yet approved. Detailed results from this cohort will be submitted for presentation at the next medical meeting and shared with the US Food and Drug Administration to support possible approval for BRAFTOVI in combination with cetuximab and Folfiri in patients with BRAF V600E-mutant mCRC.
In December 2024, BRAFTOVI in combination with cetuximab and mFOLFOX6 received accelerated approval by the FDA for patients with BRAF V600E-mutant mCRC based on a clinically meaningful and statistically significant improvement in confirmed ORR in treatment-naive patients, one of the study’s primary endpoints. Continued approval for this indication is dependent on verification of clinical benefit.
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