Pfizer confirms Braftovi’s survival benefit

At the recent ASCO Gastrointestinal Cancers symposium Pfizer’s Braftovi seemed headed towards a survival benefit in first-line BRAF-mutated colorectal cancer, and the company confirmed this on Monday, toplining progression-free and overall survival wins in the phase 3 Breakwater trial. Braftovi, in combination with Erbitux and chemo, gained accelerated approval in this setting in December, based on ORR data from Breakwater; PFS (a co-primary endpoint) and OS (a secondary endpoint) could support full approval. Pfizer didn’t give detailed PFS and OS results, saying these would be presented at an upcoming medical meeting. But at ASCO-GI an immature analysis found a 53% reduction in risk of death with the triplet versus the standard of care of chemo with or without Avastin. Braftovi was approved in 2020 for second-line BRAF-mutated colorectal cancer; it’s also indicated, alongside Mektovi, in BRAF-mutated melanoma and NSCLC. Braftovi originally belonged to Novartis, which handed it to Array to focus on the rival BRAF inhibitor Tafinlar; Array was later taken out by Pfizer. Novartis is ahead in terms of sales: Tafinlar made $2.1bn in 2024, versus Braftovi’s in $437m the first nine months of that year. But Pfizer’s edge in colorectal cancer now looks stronger.