Triplet Therapy for BRAF V600E–Mutant Metastatic Colorectal Cancer
Posted: Thursday, April 25, 2019
The safety lead-in to the phase III BEACON Colorectal Cancer trial, published in the Journal of Clinical Oncology, showed evidence of a reasonable safety profile and activity with the triple therapy of encorafenib, binimetinib, and cetuximab for BRAF V600E–mutant metastatic colorectal cancer. The study was conducted by Eric Van Cutsem, MD, PhD, of the University of Leuven, Belgium, and international colleagues.
“The observed efficacy is promising compared with available therapies and, if confirmed in the randomized portion of the trial, could establish this regimen as a new standard of care for previously treated BRAF V600E–mutant [metastatic colorectal cancer],” they concluded.
Before randomization, 30 patients were enrolled in the safety lead-in phase. The patients, who had BRAF V600E–mutant metastatic colorectal cancer, had not responded to or no longer responded to 1 or 2 prior therapies. The triple therapy included encorafenib (300 mg daily), binimetinib (45 mg twice daily), and cetuximab (400 mg/m2 followed by 250 mg/m2 in 28-day cycles).
Of the 30 patients, 5 experienced dose-limiting toxicities. The most common adverse events of any grade were diarrhea (77%), dermatitis acneiform (67%), fatigue (63%), and nausea (63%). The most common grade 3 or 4 adverse events were fatigue, anemia, and increased aspartate aminotransferase.
The median duration of follow-up was 18.2 months, and the median time on study drug was 7.9 months. Of 29 evaluable patients, the confirmed overall response rate was 48%, and the median overall survival was 15.3 months.
Disclosure: The study authors’ disclosure information may be found at ascopubs.org.