Pfizer announced positive results from a phase 3 trial evaluating its Braftovi capsules in combination with Eli Lilly’s Erbitux (cetuximab) and a chemotherapy regimen known as mFOLFOX6 in patients with metastatic colorectal cancer with a BRAF V600E mutation.
The FDA granted accelerated approval to the combination as a first-line treatment option for BRAF V600E-mutant mCRC last month, with continued approval contingent upon verification of clinical benefit, which the BREAKWATER study continues to deliver.
According to Pfizer, clinically meaningful and statistically significant results from the BREAKWATER trial show objective response rate of 61% with the Braftovi combination regimen compared to 40% with investigator’s choice of chemotherapy, representing a doubling of the odds of achieving an objective response.
“These data from the BREAKWATER study show the potential for this targeted treatment regimen to become the new standard of care for people with BRAF V600E -mutant metastatic colorectal cancer, for whom long-term disease control is critical,” said Scott Kopetz, professor and deputy chair of Gastrointestinal Medical Oncology at MD Anderson Cancer Center and co-principal investigator of the BREAKWATER trial.
Braftovi capsules were first approved in 2018 in combination with Pfizer’s Mektovi tablets for unresectable or metastatic melanoma with BRAF mutations. Braftovi, a kinase inhibitor, also has approvals in non-small cell lung cancer with BRAF mutations.
The recent BRAF V600E-mutant mCRC approval was among the first in the industry to be conducted under the FDA’s Project FrontRunner, a new framework designed to encourage drugmakers to develop and seek approval of cancer drugs for advanced or metastatic disease in an earlier clinical setting.
The BREAKWATER data are also being discussed with other regulatory authorities around the world to support potential future additional license applications for the Braftovi combination regimen in this indication.