BRAFTOVI combinations showed statistically significant improvement in OS and ORR versus control – – Data supports potential to be the first chemotherapy-free, targeted regimen for BRAF-mutant mCRC patients – – Results were presented in an oral presentation today, July 6, 2019
Array BioPharma Inc. (Nasdaq: ARRY) today announced the presentation of results from the Phase 3 BEACON CRC trial evaluating the combination of BRAFTOVI® (encorafenib), a BRAF inhibitor, MEKTOVI® (binimetinib), a MEK inhibitor, and ERBITUX® (cetuximab), an anti-EGFR antibody (BRAFTOVI Triplet), in patients with advanced BRAFV600E-mutant metastatic colorectal cancer (mCRC), following one or two lines of therapy. Data presented included primary and secondary endpoints, waterfall plots describing tumor reduction, subgroup analyses, and exploratory analyses comparing overall survival (OS) of the BRAFTOVI Triplet and BRAFTOVI Doublet (BRAFTOVI and cetuximab) in a subset of patients with mature follow-up, including the first 331 randomized patients, as well as safety and tolerability.
Results showed that BRAF-mutant mCRC patients treated with the BRAFTOVI Triplet combination demonstrated a statistically significant improvement in OS (9.0 months vs. 5.4 months, [HR 0.52, (95% CI 0.39-0.70), p<0.0001]) and objective response rate (ORR) (26.1% vs. 1.9%, p<0.0001, as assessed by Blinded Independent Central Review (BICR)) compared to cetuximab plus irinotecan-containing regimens (Control). Median progression-free survival (mPFS) for patients treated with the BRAFTOVI Triplet was 4.3 months [HR 0.38, (95% CI 0.29, 0.49), p<0.0001] compared to 1.5 months observed with the Control arm.
These data were presented in an oral presentation on Saturday, July 6, at the ESMO 21st World Congress on Gastrointestinal Cancer in Barcelona, Spain.
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