Pfizer has shared positive survival results from a late-stage study of its Braftovi (encorafenib) regimen in patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC).
Data from the phase 3 BREAKWATER trial, which has been evaluating the drug in combination with Eli Lilly/Merck KGaA’s Erbitux (cetuximab) and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin), was presented at this year’s American Society of Clinical Oncology (ASCO) annual meeting.
The Braftovi regimen was shown to reduce the risk of disease progression or death by 47% compared to standard-of-care chemotherapy with or without bevacizumab, meeting the study’s dual primary endpoint.
Results from a second interim analysis of overall survival, a key secondary endpoint, also demonstrated that the Braftovi regimen lowered the risk of death by 51% compared to chemotherapy with or without bevacizumab.
Around 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.
Taken orally, Braftovi is a 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.
Braftovi, in combination with Erbitux and mFOLFOX6, was granted accelerated approval in the US at the end of last year to treat patients with BRAF V600E-mutant mCRC. The authorisation was based on a clinically meaningful and statistically significant improvement in confirmed objective response rate, BREAKWATER’s other dual primary endpoint.
Pfizer outlined that the BREAKWATER survival data is now being discussed with the FDA to support the potential conversion to full approval for the combination in this indication.
Johanna Bendell, chief oncology development officer at Pfizer, said: “The Braftovi combination helped significantly reduce the risk of disease progression or death, potentially altering the course of disease for people with mCRC with a BRAF V600E mutation.
“These unprecedented results from the BREAKWATER trial further establish the benefit of the Braftovi combination regimen and its potential to become a new standard of care…”
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.