Dr. Lenz on Breakthrough Designation of Encorafenib, Binimetinib, and Cetuximab in BRAF+ CRC

Heinz-Josef Lenz, MD
Published: Wednesday, Oct 17, 2018



Heinz-Josef Lenz, MD, associate director for Adult Oncology and co-leader of the Gastrointestinal Cancers Program, USC Norris Comprehensive Cancer Center, discusses the FDA breakthrough designation status of encorafenib (Braftovi), binimetinib (Mektovi), and cetuximab (Erbitux) for the treatment of patients with BRAF V600E-mutant metastatic colorectal cancer (CRC).

The FDA granted the triplet breakthrough designation status on August 7, 2018 following 1 or 2 prior lines of treatment in the metastatic setting. For BRAF-mutant patients, this is a big change in the treatment approach, says Lenz. Multiple studies have shown benefit with the triplet combination of a BRAF inhibitor in the center with a MEK inhibitor. Previously, it had been tested with PI3K inhibitors and with VEGF-receptor inhibitors. In this case, cetuximab showed very promising results. In refractory patients, response rates over 30% were seen, which is unprecedented, Lenz says.

Data presented at the 2018 World Congress on Gastrointestinal Cancer showed not only high response rates, but long progression-free survival and overall survival, notes Lenz. That is the reason that there is a trial being developed in the first-line setting. Additionally, the triplet has no cytotoxins, only targeted agents.


Heinz-Josef Lenz, MD, associate director for Adult Oncology and co-leader of the Gastrointestinal Cancers Program, USC Norris Comprehensive Cancer Center, discusses the FDA breakthrough designation status of encorafenib (Braftovi), binimetinib (Mektovi), and cetuximab (Erbitux) for the treatment of patients with BRAF V600E-mutant metastatic colorectal cancer (CRC).

The FDA granted the triplet breakthrough designation status on August 7, 2018 following 1 or 2 prior lines of treatment in the metastatic setting. For BRAF-mutant patients, this is a big change in the treatment approach, says Lenz. Multiple studies have shown benefit with the triplet combination of a BRAF inhibitor in the center with a MEK inhibitor. Previously, it had been tested with PI3K inhibitors and with VEGF-receptor inhibitors. In this case, cetuximab showed very promising results. In refractory patients, response rates over 30% were seen, which is unprecedented, Lenz says.

Data presented at the 2018 World Congress on Gastrointestinal Cancer showed not only high response rates, but long progression-free survival and overall survival, notes Lenz. That is the reason that there is a trial being developed in the first-line setting. Additionally, the triplet has no cytotoxins, only targeted agents.



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