OBR Daily Commentary - Colorectal

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Array BioPharma Announces Braftovi + Mektovi + Cetuximab Meet Primary Endpoints of ORR and OS in Phase 3 BEACON CRC Trial Interim Analysis for the Treatment of BRAF(V600E)-mutant Metastatic Colorectal Cancer

(Array) May 21, 2019 - Braftovi combinations showed statistically significant improvement in ORR and OS versus control. Braftovi + Mektovi + cetuximab reduced the risk of death by 48% versus control. Potential to be the first chemotherapy-free, targeted regimen for metastatic CRC patients.

Howard S. Hochster, MD (Posted: May 22, 2019)

quotesIn a long expected result, the 2nd-3rd line BEACON trial of encorafenib and binimetinib (with or without cetuximab) compared with the standard Irinotecan and cetuximab, in a 3-arm randomized trial (N=663) showed the benefit of these improved BRAF and MEK inhibitors for BRAF-mutated mCRC. These newer generation signal transduction inhibitors were expected to show improved outcomes compared with earlier inhibitors, based on prior results. The triplet showed improved RR (26 vs . 19%) compared with the standard arm and OS (9.0 vs 5.4 months), both reaching statistical significance. The triplet was better than the doublet but this did not reach statistical significance. Both of these kinase inhibitors are already approved for melanoma, and fall within the NCCN guidelines. This regimen should be considered a standard for the 8% of mCRC with BRAF mutation, following FOLFOX first line therapy. Another option is irinotecan, cetuximab and vemurafenib as shown in the S1406 trial, also chaired by Scott Kopetz. While a small subset of mCRC, this is the first "all biologic" combination therapy in CRC and a great step forward for patient therapy. quotes

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