The investigational treatment encorafenib (Braftovi) has received Breakthrough Therapy Designation as combination therapy with binimetinib (Mektovi) and cetuximab for patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC), after failure of 1 to 2 prior lines of therapy for metastatic disease.

Encorafenib (Array BioPharma), an oral small molecule BRAF kinase inhibitor, and binimetinib, an oral small molecule MEK inhibitor, target key enzymes in the MAPK signaling pathway (RAS-RAF-MEK-ERK). The combination of encorafenib and binimetinib is already approved in the US to treat unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation. 

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The Company announced early data from their Phase 3 randomized, open-label trial (BEACON CRC) of encorafenib, binimetinib, and cetuximab in 29 patients with BRAFV600E-mutant mCRC. Encorafenib in combination with cetuximab with or without binimetinib is being compared to cetuximab and irinotecan-based therapy. The primary endpoint of the trial will be overall survival (OS) of the triplet combination compared to the control arm. 

At the time of analysis, 1-year OS rate was 62% with median progression-free survival (mPFS) of 8 months (95% CI, 5.6-9.3). Confirmed overall response rate (ORR) was 48% and among the patients who received only 1 prior line of therapy (n=17), the ORR was 62%. In general, the triple therapy was well-tolerated with no unexpected toxicities. 

“As there are no regimens approved specifically for BRAFV600E-mutant mCRC, this designation provides us with the opportunity to work closely with the FDA to potentially accelerate our effort to bring an important treatment option to these patients in critical need,” said Victor Sandor, MD, CMO of Array BioPharma.

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