People with metastatic colorectal cancer and what are known as BRAF mutations benefited from improved overall survival time when treated with a three-drug combination of Braftovi (encorafenib), Mektovi (binimetinib) and Erbitux (cetuximab) in a recent study.
Scott Kopetz, MD, an associate professor of gastrointestinal medical oncology at the University of Texas MD Anderson Cancer Center led the international research team behind the Phase III BEACON CRC study of BRAF-MEK combination targeted therapy among 665 people with metastatic colorectal cancer and the BRAF V600E mutation. Kopetz presented findings from the trial at the ESMO World Congress on Gastrointestinal Cancer this month in Barcelona.
Approximately 15% of those with metastatic colorectal cancer have BRAF mutations, the most
common of which is known as V600, which is linked to a poor prognosis.
In August 2018, the Food and Drug Administration (FDA) granted a breakthrough therapy designation to Braftovi in combination with Mektovi and Erbitux for people with previously treated BRAF V600E-mutant metastatic colon cancer.
The study participants had all seen their disease progress following the use of one or two prior treatments for metastatic cancer. They were randomized into three even groups:
- Triple therapy with Braftovi, Mektovi and Erbitux
- Double therapy with Braftovi and Erbitux
- The trial investigator’s choice of either irinotecan or FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy plus Erbitux.
The median overall survival time was 9.0 months for those who received the triple treatment compared with 5.4 months for those who received the investigator-chosen standard of care therapy. The objective response rates for each treatment were a respective 26% and 2%.
The study was not intended to compare the triple therapy with the double therapy. Nevertheless, future analyses will try to determine which individuals stand the greatest chance of benefiting from the triple treatment over the double.
The triple combo proved generally well tolerated; participants experienced no unexpected toxicities. Of those who received triple therapy, 58% experienced Grade 3 or higher adverse events, as did 50% of those in the double group and 61% of those in the investigator-chosen standard therapy group.
Findings from the BEACON CRC trial have been provided to the FDA to support approval of the triple combination for this patient population.
“This targeted therapy combination should be a new standard of care for this patient group,” Kopetz said in a press release. “Further investigation is needed to determine if this combination may also benefit those with less advanced disease or as a first-line treatment.”
To read the study abstract, click here.
To read a press release about the study, click here.