Pfizer (PFE) announced on Tuesday that its colorectal cancer therapy, Braftovi, as part of a combination regimen, improved patient survival, reaching a key secondary endpoint in a late-stage trial.
Citing topline data from Cohort 3 of its pivotal BREAKWATER trial, PFE said that the oral kinase inhibitor it markets for Ono Pharmaceutical (OPHLF) (OPHLY) in Japan and Korea improved progression-free survival with a statistically significant and clinically meaningful effect.
Cohort 3 was designed to evaluate Braftovi with cetuximab, marketed by Merck KGaA (MKGAF) (MKKGY) as Erbitux, with the chemotherapy regimen Folfiri.
According to the company, the Braftovi combo led to a clinically meaningful benefit in overall survival, another secondary endpoint in the study that enrolled patients with newly diagnosed metastatic colorectal cancer with a BRAF V600E mutation.
There were no new safety signals, and Braftovi with cetuximab and Folfiri indicated a tolerability profile consistent with the already established safety findings of individual treatments.
In December 2024, the FDA granted accelerated approval for Braftovi as part of a combination regimen for BRAF V600E-mutant mCRC.
Pfizer (PFE) plans to submit Cohort 3 data from BREAKWATER seeking FDA approval of the oral kinase inhibitor for BRAF V600E-mutant mCRC in combination with cetuximab and Folfiri.