Significantly longer progression-free and overall survival seen in patients with BRAF V600E mutations
FRIDAY, May 30, 2025 (HealthDay News) — For patients with BRAF V600E-mutated metastatic colorectal cancer, progression-free and overall survival are significantly longer with encorafenib plus cetuximab (EC) plus chemotherapy (oxaliplatin, leucovorin, and fluorouracil [mFOLFOX6]), according to a study published online May 30 in the New England Journal of Medicine to coincide with the annual meeting of the American Society of Clinical Oncology, held from May 31 to June 4 in Chicago.
Elena Elez, M.D., Ph.D., from Vall d”Hebron Hospital Campus in Barcelona, Spain and colleagues conducted an open-label study in which they randomly assigned patients with untreated BRAF V600E-mutated metastatic colorectal cancer to receive EC, EC+mFOLFOX6, or standard care consisting of chemotherapy with or without bevacizumab (158, 236, and 243 patients, respectively). Data on progression-free survival and an updated interim analysis of overall survival were presented.
The researchers found that progression-free survival was significantly longer with EC+mFOLFOX6 than standard care (median, 12.8 versus 7.1 months; hazard ratio for progression or death, 0.53). Overall survival was significantly longer with EC+mFOLFOX6 than with standard care in an interim analysis (median, 30.3 versus 15.1 months; hazard ratio for death, 0.49). The incidence of serious adverse events during treatment was 46.1 and 38.9 percent with EC+mFOLFOX6 and standard care, respectively; safety profiles were consistent with known profiles for each agent.
“The benefits with regard to both progression-free survival and overall survival with EC+mFOLFOX6 were observed across all the prespecified clinical subgroups, including in patients with liver metastases or with involvement of three or more organs,” the authors write.
Several authors disclosed ties to Pfizer, which funded the study, with support from Ono Pharmaceutical, Merck, and Eli Lilly.
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