Article Figures & Data
Figures
- Figure 1
Schematic diagram of the overall structure of this perspective.
Tables
Trial Targeted gene variations Treatment regimen Target population Outcomes Recommended by guidelines BEACON BRAF p.V600E Encorafenib + cetuximab mCRC with BRAF p.V600E mutation mOS 9.3 months, ORR 19.5% Encorafenib + cetuximab + binimetinib mOS 9.3 months, ORR 26.8% SWOG S1406 BRAF p.V600E Vemurafenib + cetuximab + irinotecan mCRC with BRAF p.V600E mutation ORR 17%, DCR 65% MyPathway HER2 amplification Trastuzumab + pertuzumab HER2-amplified mCRC ORR 32% DESTINY-CRC01 HER2 amplification Trastuzumab deruxtecan (DS8201) HER2-positive mCRC, immunohistochemistry (IHC) 3+ or IHC2+ and in-situ hybridization (ISH)-positive ORR 45.3% NAVIGATE NTRK fusion Larotrectinib CRC with NTRK gene fusion mPFS 5.3 months, mOS 33.4 months CONCUR Multiple kinases (including VEGF receptors, fibroblast growth factor receptors, platelet-derived growth factor receptors, BRAF, KIT, and RET) Regorafenib Refractory progressive mCRC mOS 8.8 months vs. 6.3 months Potential and ongoing Hong 2020 KRAS p.G12C Sotorasib (AMG-510) CRC with KRAS p.G12C mutation ORR 7.1%, DCR 73.8%, mPFS 4.0 months KRYSTAL-1 KRAS p.G12C Adagrasib CRC with KRAS p.G12C mutation ORR 22%, DCR 87%, mPFS 5.6 months Adagrasib + cetuximab ORR 43%, DCR 100% NCT05737706 KRAS p.G12D MRTX1133 CRC with KRAS p.G12D mutation Status: recruiting AMPLIFY-201 KRAS G12D, KRAS G12R ELI-002 2P CRC with KRAS/NRAS p.G12D or p.G12R mutation Status: active, not recruiting NCT04627142 pan-KRAS BI 1701963 mCRC with confirmed KRAS mutations Status: terminated STARTRK-2 NTRK1/2/3 Entrectinib (RXDX-101) mCRC with NTRK1/2/3-rearrangement (fusion) Status: active, not recruiting DCR, disease control rate; mPFS, median progression-free survival; mOS, median overall survival; ORR, objective response rate.
- Table 2
Key clinical trials of ICI-based immunotherapy in MSI-H/dMMR and/or MSS/pMMR CRC cohorts
Trial Treatment regimen Target population Number of patients Sponsor Outcomes Targeting MSI-H/dMMR CRCs KEYNOTE-016 Pembrolizumab in chemorefractory patients MSI-H/dMMR CRC; MSS/pMMR CRC 9 (MSI-H)/41 Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins ORR of MSI-H CRC 40.0% KEYNOTE-164 Pembrolizumab in chemorefractory patients MSI-H/dMMR mCRC with ≥ 1 prior line of therapy 63 Merck Sharp & Dohme LLC ORR 33%, mPFS 4.1 months CheckMate-142 Nivolumab plus ipilimumab MSI-H/dMMR mCRC with no prior treatment 45 Bristol-Myers Squibb ORR 69%, DCR 84% KEYNOTE-177 Pembrolizumab as first-line therapy MSI-H/dMMR CRC 307 Merck Sharp & Dohme LLC ORR 45.1%, mPFS 16.5 months NICHE Ipilimumab plus nivolumab; pMMR group with or without celecoxib MSI-H/dMMR or MSS/pMMR CRC 40 The Netherlands Cancer Institute ORR 100% in dMMR CRC, 27% in pMMR CRC Targeting MSS/pMMR CRCs REGONIVO Regorafenib plus nivolumab MSS/pMMR CRC with ≥ 2 previous lines of chemotherapy 25 Kohei Shitara, National Cancer Center Hospital East ORR 36%, mPFS 7.9 months REGOTORI Regorafenib plus toripalimab MSS/pMMR CRC with ≥ 2 previous lines of chemotherapy 42 Second Affiliated Hospital, School of Medicine, Zhejiang University ORR 15.2%, mPFS 2.1 months, mOS 15.5 months Fakih 2023 Regorafenib, ipilimumab and nivolumab MSS/pMMR mCRC 39 City of Hope Medical Center ORR 27.6%, mPFS 4 months, mOS 20 months KEYNOTE-651 mFOLFOX7 plus pembrolizumab MSS/pMMR mCRC with no prior treatment 31 Merck Sharp & Dohme LLC mPFS 9 months, mOS 29 months METIMMOX-2 Oxaliplatin plus nivolumab MSS/pMMR mCRC with no prior treatment 28 University Hospital, Akershus ORR 32% BBCAPX Sintilimab plus bevacizumab and oxaliplatin and capecitabine RAS-mutant and MSS/pMMR mCRC with no prior treatment 25 Second Affiliated Hospital, School of Medicine, Zhejiang University ORR 84.0%, DCR 100%, mPFS 18.2 months NIVACOR FOLFOXIRI plus bevacizumab and nivolumab RAS/BRAF-mutant mCRC 52 (MSS)/73 Gruppo Oncologico Italiano di Ricerca Clinica MSS CRC: ORR 78.9%, DCR 96.2%, mPFS 9.8 months DCR, disease control rate; mPFS, median progression-free survival; mOS, median overall survival; ORR, objective response rate.
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