Pfizer has announced positive topline results from the Phase 3 BREAKWATER study of the Braftovi (encorafenib) combination regimen in colorectal cancer patients.
The study assessed Braftovi combined with ERBITUX (cetuximab) and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) in metastatic colorectal cancer (mCRC) patients with a BRAF V600E mutation.
The trial showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS), one of the dual primary endpoints. This was compared to patients receiving chemotherapy with or without bevacizumab.
Additionally, the Braftovi combination regimen demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), a key secondary endpoint.
In September 2024, Braftovi in combination with Mektovi (binimetinib) showed a positive response in patients with BRAF V600E-mutant metastatic non-small cell lung cancer (NSCLC) in a Phase 2 trial.
Pfizer chief oncology officer Roger Dansey said: “We are extremely pleased with the clinically meaningful progression-free survival and overall survival results from the BREAKWATER study, which have the potential to be practice-changing for this patient population that has historically had limited treatment options and poor outcomes.
“The Braftovi regimen is emerging as a new standard of care as the first targeted therapy approved for use as early as first-line for patients with mCRC with a BRAF V600E mutation.
“We look forward to discussing these data with global health authorities to bring this treatment to more patients around the world, as soon as possible.”
The Braftovi combination regimen secured accelerated approval from the US Food and Drug Administration (FDA) in December 2024 for its use in treatment-naïve patients with BRAFV600E-mutant mCRC.
The approval is based on a significant improvement in the confirmed objective response rate (ORR), one of the study’s other dual primary endpoints.
The ORR analysis showed that the safety profile of Braftovi, in combination with cetuximab and mFOLFOX6, remained consistent with the known safety profiles of each drug.
No new safety signals were identified. Detailed results will be submitted for presentation at a future medical meeting.
Pfizer plans to share the latest results with the FDA to support full approval of Braftovi in combination with cetuximab and mFOLFOX6 for mCRC patients with a BRAF V600E mutation.
The BREAKWATER data are also being discussed with global regulatory authorities for potential additional licence applications.
