Pfizer has announced that its Braftovi (encorafenib) regimen significantly improved both progression-free and overall survival in a late-stage colorectal cancer (CRC) study.
The ongoing phase 3 BREAKWATER trial has been evaluating the drug in combination with Eli Lilly/Merck KGaA’s Erbitux (cetuximab) and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) in patients with previously untreated BRAF V600E-mutant metastatic CRC.
The Braftovi regimen demonstrated statistically significant and clinically meaningful improvements in the dual primary endpoint of progression-free survival and the key secondary endpoint of overall survival compared chemotherapy with or without bevacizumab.
Approximately 154,270 people are expected to be diagnosed with cancer of the colon or rectum in the US this year. BRAF mutations are estimated to occur in up to 12% of those with metastatic cases of the disease and are associated with a poor prognosis.
Braftovi is an oral small molecule kinase inhibitor designed to target the most common BRAF mutation, BRAF V600E, which more than doubles patients’ risk of death compared to those with no known mutation present.
The drug was granted accelerated approval by the US Food and Drug Administration (FDA) in December in combination with Erbitux and mFOLFOX6 for treatment-naïve patients with BRAF V600E-mutant metastatic CRC based on a clinically meaningful and statistically significant improvement in confirmed objective response rate, BREAKWATER’s other dual primary endpoint.
Pfizer said it will now be sharing the new trial results with the FDA to support the potential conversion to full approval for the combination in this indication, adding that the data is also being discussed with other regulatory authorities globally.
Pfizer’s 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 metastatic CRC with a BRAF V600E mutation. We look forward to discussing this data with global health authorities to bring this treatment to more patients around the world, as soon as possible.”
Pfizer has exclusive rights to Braftovi in the US, Canada, Latin America, the Middle East and Africa, while licences are also held by Ono Pharmaceutical, Medison and Pierre Fabre.