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. 2023 Jan 16;15:17588359221148540. doi: 10.1177/17588359221148540

Table 2.

Selected past and ongoing prospective clinical trials on targeted therapy and immunotherapy in BRAF V600E metastatic CRC.

Trial Phase Sample size Treatment arm(s) Line of treatment (and MSI status) ORR (%) mPFS (months) mOS (months)
Combined BRAF, EGFR ± MEK inhibition
 Yaeger et al.84 I 15 Vemurafenib + panitumumab ⩾2L 13 3.2 7.6
 Corcoran et al.89 I 20 Dabrafenib + panitumumab ⩾1L 10 3.5 13.2
91 Dabrafenib + panitumumab + trametinib ⩾1L 21 4.2 9.1
 BEACON CRC85 III 220 Encorafenib + cetuximab (versus cetuximab + irinotecan-based chemotherapy) ⩾2L 19.5 (versus 1.8) 4.3 (versus 1.5) 9.3 (versus 5.9)
224 Encorafenib + cetuximab + binimetinib (versus cetuximab + irinotecan-based chemotherapy) ⩾2L 26.8 (versus 1.8) 4.5 (versus 1.5) 9.3 (versus 5.9)
 ANCHOR CRC87 (NCT03693170) II 92 Encorafenib + cetuximab + binimetinib 1L 47.8 5.8 17.2
 BREAKWATER (NCT04607421) III 765 (in 3 arms) Encorafenib + cetuximab versus encorafenib + cetuximab + FOLFOX (versus bevacizumab + FOLFOX/FOLFIRI/XELOX) 1L
Immunotherapy plus BRAF doublet inhibition
 Corcoran et al.92 II 20 Dabrafenib + trametinib + spartalizumab Unspecified (MSI-unselected) 35
 Morris et al.93 II 23 Encorafenib + cetuximab + nivolumab ⩾2L (MSS patients) 48 7.4 15.1
 SWOG 2107 (NCT05308446) II 84 (in 2 arms) Encorafenib + cetuximab + nivolumab (versus encorafenib + cetuximab) ⩾2L (MSS patients)
 SEAMARK (NCT05217446) II 104 (in 3 arms) Encorafenib + cetuximab + pembrolizumab (versus pembrolizumab alone) 1L (MSI-high patients)
Combined BRAF, EGFR and PI3K inhibition
 Tabernero et al.94 II 52 Encorafenib + cetuximab + alpelisib (versus encorafenib + cetuximab) ⩾2L 27 (versus 22) 5.4 (versus 4.2) 15.2 (versus not reached)
BRAF and EGFR inhibition plus irinotecan
 SWOG S140690 II 50 Vemurafenib + cetuximab + irinotecan versus cetuximab + irinotecan 2L/3L 17 (versus 4) 4.2 (versus 2.0) 9.6 (versus 5.9)

BRAF, serine/threonine-protein kinase B-Raf; CRC, colorectal cancer; EGFR, epidermal growth factor receptor; MEK, mitogen-activated protein kinase kinase; mOS, median overall survival; mPFS, median progression-free survival; MSI, microsatellite instability; MSS, microsatellite stability; ORR, objective response rate; PI3K, phosphoinositide 3-kinase.