American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium 2026 | News | Updates | iPharmaCenter
- Badari Andukuri
- 22 hours ago
- 2 min read
Pfizer Braftovi -Based Combination Regimen With Enhanced Chemotherapy Backbone Boosts Response Rates in Select Patients With Metastatic Colorectal Cancer
Pfizer has announced new Phase 3 data from the BREAKWATER trial showing that an Braftovi (encorafenib) based combination can substantially improve response rates in certain patients with advanced colorectal cancer carrying a BRAF V600E mutation.
In a randomized cohort of previously untreated metastatic colorectal cancer, the regimen combining Braftovi (encorafenib), an anti‑EGFR antibody, and FOLFIRI chemotherapy achieved a confirmed objective response rate of roughly 64% compared with about 39% for patients receiving standard FOLFIRI with or without bevacizumab, as assessed by blinded independent central review. These findings suggest a higher likelihood of meaningful tumour shrinkage versus commonly used first‑line chemotherapy backbones in this molecularly defined population.
Durability of response also favored the investigational regimen, even though median duration of response was not yet calculable for either treatment arm at the time of analysis.
Around 57% of patients treated with encorafenib plus anti‑EGFR therapy and FOLFIRI maintained a response for six months or longer, compared with approximately 35% among those on FOLFIRI with or without bevacizumab.
Overall survival data were analyzed descriptively and follow‑up in the BREAKWATER trial is ongoing, with study completion expected later in the decade.
The encorafenib, anti‑EGFR, and FOLFIRI combination remains an investigational approach and is not currently authorized for use in metastatic colorectal cancer. A separate encorafenib‑based regimen with anti‑EGFR therapy and mFOLFOX6 previously received accelerated approval in the United States for adults with previously untreated BRAF V600E‑mutant metastatic colorectal cancer, based on a significant improvement in objective response rate. Continued approval for that indication will depend on confirmation of clinical benefit from ongoing and future studies, including longer‑term outcomes from BREAKWATER.