Phase III BEACON CRC trial of BRAFTOVI Triplet in colorectal cancer published in NEJM.- Pfizer Inc
Pfizer Inc. announced detailed results from the interim analysis of the Phase III BEACON CRC trial evaluating the combination of Braftovi (encorafenib), Mektovi (binimetinib), and cetuximab (BRAFTOVI Triplet), in patients with advanced BRAFV600E-mutant metastatic colorectal cancer (mCRC), following one or two lines of therapy. The results show significant improvements in overall survival (OS) and objective response rates (ORR) for the BRAFTOVI Triplet and BRAFTOVI Doublet combination (Braftovi and cetuximab), compared to cetuximab plus irinotecan-containing regimens (Control), and provide analysis of the efficacy and safety of the BRAFTOVI Triplet compared to the BRAFTOVI Doublet. As previously announced, the BRAFTOVI Triplet showed a median OS of 9.0 months for patients treated with the Triplet, compared to 5.4 months for Control.
The BRAFTOVI Triplet also demonstrated a significantly improved ORR of 26% compared to 2% for Control. The study also showed improvements in secondary efficacy endpoints. As previously announced, the BRAFTOVI Doublet showed a statistically significant improvement in OS (median 8.4 months vs. 5.4 months) compared to Control. Additional analysis showed depth of responses in favor of the BRAFTOVI Triplet.
Further, the data provide additional details on the primary and secondary endpoints, including observations of response rates by number of lines of prior therapy, as well as a descriptive analysis of OS comparing the BRAFTOVI Triplet to the BRAFTOVI Doublet. Pfizer intends to submit the results of the BEACON CRC trial for marketing approval in the U.S. in the fourth quarter of 2019. These data will be presented during a late-breaking oral session at the 2019 European Society for Medical Oncology (ESMO) Congress and simultaneously published online in The New England Journal of Medicine (NEJM).
See: "Encorafenib, Binimetinib, and Cetuximab in BRAF V600E�Mutated Colorectal Cancer" Scott Kopetz et al. NEJM September 30, 2019 DOI: 10.1056/NEJMoa1908075
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