Braftovi, Mektovi, cetuximab – pro
The NCCN added a new precision cancer medicine treatment regimen to their treatment guidelines for colon cancer with the BRAFV600 genetic mutation. The new treatment combines 3 drugs; the BRAF and MEK inhibitors Braftovi™(encorafenib), and Mektovi® (binimetinib) and cetuximab. (1) Study results were updated at ESMO and in the J Clin Oncol. March, 2019, (2,3) leading to US Food and Drug Administration approval in April 2020. The V600E mutation in the BRAF gene is found in about 10% of metastatic colorectal cancers and is associated with especially poor outcomes. he trial investigators compared both a three-drug combination of encorafenib, cetuximab, and binimetinib (Mektovi) and a two-drug combination of encorafenib and cetuximab with standard chemotherapy plus cetuximab (the control arm). Both combinations were superior to standard treatment, and the two-drug combination was just as effective as the three-drug regimen.
Patients who received encorafenib and cetuximab had a median overall survival of 8.4 months compared with 5.4 months for patients in the control arm. Also, more patients who received the two-drug combination had reductions in the size of their tumors (a tumor response) than patients in the control arm: 20% versus 2%.
Kopetz S, Grothey A, Yaeger R, Van Cutsem E, Desai J, Yoshino T, Wasan H, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Pfeiffer P, Orlov S, Lonardi S, Elez E, Kim TW, Schellens JHM, Guo C, Krishnan A, Dekervel J, Morris V, Calvo Ferrandiz A, Tarpgaard LS, Braun M, Gollerkeri A, Keir C, Maharry K, Pickard M, Christy-Bittel J, Anderson L, Sandor V, Tabernero J. Encorafenib, Binimetinib, and Cetuximab in BRAF V600E–Mutated Colorectal Cancer. N Engl J Med. 2019 Oct 24;381(17):1632-1643.
NCCN Colon Cancer 2020
Braftovi Prescribing Information 2020