Global pharma giant Pfizer has announced groundbreaking results from Cohort 3 of its pivotal BREAKWATER trial, showing that its BRAFTOVI (encorafenib) regimen significantly extends progression-free survival in patients with previously untreated metastatic colorectal cancer (mCRC).

 

The regimen combines BRAFTOVI with cetuximab and FOLFIRI chemotherapy, and results from a blinded independent central review (BICR) showed a statistically significant and clinically meaningful improvement in PFS compared with standard treatments. Overall survival (OS) also trended favorably.

 

“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,” said Jeff Legos, Chief Oncology Officer at Pfizer. 

 

“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.”

 

BREAKWATER is a Phase 3, randomized, open-label trial testing BRAFTOVI in combination with cetuximab, either alone or with chemotherapy, in patients with untreated BRAF V600E-mutant mCRC. 

 

Cohort 3 included 73 patients receiving BRAFTOVI with cetuximab and FOLFIRI and 74 in a control arm receiving FOLFIRI, with or without bevacizumab. The cohort’s primary endpoint was objective response rate (ORR), with PFS and OS as secondary endpoints.

 

The safety profile of the BRAFTOVI combination remained consistent with known data, and no new safety signals were observed.