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FDA Approves Cetuximab-Based Combo for Colorectal Cancer Subset
On September 29. 2021, the FDA approved cetuximab in combination with encorafenib for a subset of patients with colorectal cancer. This subset applies to treatment-naïve patients with a BRAF V600E mutation and positive metastatic disease.
Cetuximab acts as an epidermal growth factor receptor inhibitor to work in combination with encorafenib as an oral small molecule kinase inhibitor that targets the BRAF V600E mutation.
The approval was based on the results of the randomized phase 3 BEACON CRC trial. Patients with BRAF V600E-mutant metastatic colorectal cancer were enrolled to treat disease progression after 1 or 2 regimens.
Patients were randomly assigned to 1 of the following regimens: encorafenib 300 mg orally once daily in combination with cetuximab, encorafenib 300 mg orally once daily in combination with cetuximab and binimetinib, or cetuximab with either irinotecan or FOLFIRI.
The primary endpoint was overall survival (OS) with secondary endpoints being progression-free survival (PFS), objective response rate (ORR), and duration of response (DOR).
Results of the trial showed longer rates with extended OS (8.4 months vs. 5.4 months; HR = 0.6; 95% CI, 0.45-0.79), 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 patients assigned to cetuximab-encorafenib.
Significant improvements in response rates for those with a BRAF V600E mutation have allowed for cetuximab-encorafenib to be approved as an accessible treatment regimen for patients with metastatic colorectal cancer.—Alexa Stoia
