Another of Pfizer’s Braftovi regimens has shown benefit in patients with previously untreated metastatic colorectal cancer (mCRC) with a BRAF V600E mutation.
Patients in cohort three of the Phase III BREAKWATER trial (NCT04607421) received a combination of Braftovi (encorafenib), Erbitux (cetuximab) and Folfiri (fluorouracil, leucovorin, and irinotecan) or Folfiri with or without Avastin (bevacizumab).
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In the trial, patients who received the combination showed improved progression-free survival (PFS). Overall survival (OS), a descriptive secondary endpoint, also showed 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 mCRC. 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.”
Pfizer previously announced that the primary endpoint of objective response rate (ORR) was achieved in the trial, with the data presented at the 2026 American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium.
The safety profile of the Braftovi combination was consistent with the known profile of each regimen component and no new safety signals were identified.
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By GlobalDataPfizer will both present the new data at an upcoming medical meeting and share the results with the US Food and Drug Administration (FDA) to support potential approval for Braftovi, an oral small molecule kinase inhibitor, in combination with Erbitux and Folfiri in patients with BRAF V600E-mutant mCRC.
Second Braftovi combo to show benefit
The trial also evaluated Braftovi in combination with Erbitux and mFOLFOX6 in a cohort of patients with BRAF V600E-mutant mCRC. The FDA granted accelerated approval to this combination in December 2024 for patients with BRAF V600E-mutant mCRC based on a clinically meaningful and statistically significant improvement in confirmed ORR in treatment-naïve patients, one of the study’s primary endpoints.
The approved Braftovi regimen reduced the risk of disease progression or death by 47% compared to standard-of-care chemotherapy with or without Avastin, meeting the study’s dual primary endpoint. The regimen also lowered the risk of death by 51% compared to chemotherapy with or without Avastin.
According to Clinical Trials Arena’s parent company GlobalData, CRC is the third most common cancer globally, with nearly two million new cases being diagnosed and 900,000 deaths every year. Of these global cases, 10% will have a BRAF V600E gene mutation implicated in carcinogenesis pathways. Standard-of-care (SOC) chemotherapy options, such as FOLFOX, have a poor OS of around 11 months.
Despite the combination’s approval, analysts believe it is unlikely to be used in older patients, as the response rate was not statistically significant in this population.
