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FDA Grants Breakthrough Therapy Designation for Encorafenib Plus Binimetinib and Cetuximab in BRAF V600E–Mutant Metastatic Colorectal Cancer

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The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for encorafenib (Braftovi) in combination with binimetinib (Mektovi) and cetuximab (Erbitux) for the treatment of patients with BRAF V600E–mutant metastatic colorectal cancer (mCRC), as detected by an FDA-approved test, after failure of one to two prior lines of therapy for metastatic disease. BRAF V600E–mutant mCRC patients have a mortality risk more than double that of mCRC patients without the mutation, and currently there are no therapies specifically approved for this high unmet need population.

As presented at the ESMO 20th World Congress on Gastrointestinal Cancer in June 2018, the results from the safety lead-in of the ongoing randomized phase III BEACON CRC trial showed that, at the time of analysis, the overall survival (OS) data were fully mature through 12.6 months and that the median OS had not yet been reached.

The 1-year OS rate for this cohort was 62%. Median progression-free survival for patients treated with the triplet was 8 months (95% confidence interval [CI] = 5.6–9.3) and is similar between patients receiving one prior line of therapy and patients receiving two prior lines of therapy. The confirmed overall response rate (ORR) was 48%, and among the 17 patients who received only one prior line of therapy, the ORR was 62%.

The triplet combination was generally well tolerated with no unexpected toxicities. The most common grade 3 or 4 adverse events seen in at least 10% of patients were fatigue (13%), anemia (10%), increased blood creatine kinase (10%) and increased aspartate aminotransferase (10%).

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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