FDA approves Braftovi with Erbitux for metastatic colorectal cancer subset
The FDA approved encorafenib in combination with cetuximab for adults with previously treated BRAF V600E-mutant metastatic colorectal cancer.
Encorafenib (Braftovi, Pfizer) is an oral small molecule kinase inhibitor that targets BRAF V600E. Cetuximab (Erbitux, Eli Lilly) is an epidermal growth factor receptor inhibitor.
The FDA based the approval on results of the randomized phase 3 BEACON CRC trial, which included patients with BRAF V600E-mutant metastatic colorectal cancer that progressed after one or two prior regimens.
Researchers randomly assigned patients 1:1:1 to one of three treatments: encorafenib dosed at 300 mg once daily in combination with cetuximab; encorafenib dosed at 300 mg once daily in combination with cetuximab and binimetinib (MEK162, Array BioPharma), an oral small molecule MEK inhibitor; or a control regimen that consisted of irinotecan with cetuximab or FOLFIRI with cetuximab.
OS served as the major efficacy outcome. Additional outcomes included PFS, overall response rate and duration of response.
As Healio previously reported, results showed patients assigned the encorafenib-cetuximab combination achieved significantly longer median OS than those in the control group (8.4 months vs. 5.4 months; HR = 0.6; 95% CI, 0.45-0.79). Researchers also reported longer median PFS (4.2 months vs. 1.5 months; HR = 0.4; 95% CI, 0.31-0.52) and a higher ORR (20% vs. 2%; P < .0001) in the encorafenib-cetuximab group vs. the control group.
The most common adverse events observed in the encorafenib-cetuximab group included fatigue, nausea, diarrhea, dermatitis acneiform, abdominal pain, decreased appetite, arthralgia and rash.
“BRAF mutations are estimated to occur in up to 15% of people with metastatic colorectal cancer and represent a poor prognosis for these patients,” Scott Kopetz, MD, PhD, FACP, associate professor of gastrointestinal medical oncology at The University of Texas MD Anderson Cancer Center, said in a Pfizer-issued press release. “As the first-and-only targeted regimen for people with BRAF V600E-mutant metastatic colorectal cancer who have received prior therapy, Braftovi in combination with cetuximab is a much-needed new treatment option for these patients.”