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Investigators Test Breakthrough-Designated Triplet in First-Line CRC

Rachel Narozniak, MA
Published: Friday, Jan 17, 2020
Rona D. Yaeger, MD

Rona D. Yaeger, MD

Investigators hope to answer a potentially paradigm-changing question in the phase II ANCHOR-CRC study (NCT03693170) of BRAF V600E–mutant colorectal cancer (CRC): Can the benefit observed with a targeted triplet in latestage disease extend to the first line?

“We anticipate that if patients responded to the regimen in later lines, they would also respond in the first line,” said Rona Yaeger, MD, an expert in CRC and gastrointestinal (GI) malignancies and the principal investigator for ANCHORCRC at Memorial Sloan Kettering Cancer Center in New York, New York.

Figure. (Click to Enlarge)



In CRC and other disease settings, targeted treatments are generally given with chemotherapy. Encorafenib, binimetinib, and cetuximab offer a chemotherapy- free alternative to this therapeutic standard and can spare patients some of the adverse events (AEs) associated with chemotherapy inclusive regimens.2 Findings from BEACON CRC showed that the triplet not only had an acceptable safety profile but also led to longer overall survival (OS) and higher response rates than standard therapy in advanced-stage disease.3 Data from the safety lead-in phase of BEACON CRC led to the triplet regimen’s breakthrough therapy designation in August 2018.4 In addition to breakthrough therapy status, the combination has received a National Comprehensive Cancer Network category 2a treatment recommendation for patients with BRAF V600E–mutant metastatic (m) CRC after failure of 1 or 2 lines of therapy.4-6 Most recently, encorafenib and cetuximab received a priority review designation for the treatment of adult patients with advanced BRAF V600E–mutant mCRC following up to 2 prior lines of treatment. The December 2019 decision was based on OS and overall response rate data from BEACON CRC. The FDA is scheduled to make a decision on the doublet therapy’s supplemental new drug application in April 2020.7

BEACON CRC enrolled 665 patients with BRAF V600E–mutant mCRC who had experienced disease progression on prior therapy. Patients were randomized 1:1:1 to receive the triplet, a doublet consisting of encorafenib and cetuximab, or investigator’s choice of either cetuximab with irinotecan or cetuximab with folinic acid, fluorouracil, and irinotecan (FOLFIRI; control group).3

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