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    TEST:
    FoundationOne® CDx

    Company:
    Roche
    Type:
    FDA Approved (PMA)
    Related tests:
    7d
    Refining Tumor Mutational Burden as a Predictive Biomarker for Pembrolizumab: A Real-World Analysis in Japanese Patients. (PubMed, Cancer Sci)
    These findings support the clinical utility of TMB as a biomarker for predicting ICI response in routine oncology practice. In particular, excluding hotspot mutations from TMB calculations may improve response prediction in patients whose TMB values are near the threshold.
    Journal • Real-world evidence • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
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    TMB (Tumor Mutational Burden)
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    TMB-H • TMB-L
    |
    FoundationOne® CDx • OncoGuide™ NCC Oncopanel System
    |
    Keytruda (pembrolizumab)
    8d
    A Study to Investigate the Effects of Multiple Doses of Rezatapopt on the Pharmacokinetics of Metformin, Rosuvastatin, Repaglinide, and Midazolam in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation. (clinicaltrials.gov)
    P1, N=14, Not yet recruiting, PMV Pharmaceuticals, Inc
    New P1 trial
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation • TP53 Y220C
    |
    FoundationOne® CDx • MSK-IMPACT • MSK-ACCESS
    |
    metformin • rezatapopt (PC14586) • midazolam hydrochloride
    10d
    NCI-2017-00831: Poziotinib in EGFR Exon 20 Mutant Advanced NSCLC (clinicaltrials.gov)
    P2, N=93, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2027
    Trial completion date • Trial primary completion date
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR mutation • EGFR exon 20 insertion • HER-2 exon 20 insertion • EGFR exon 20 mutation
    |
    FoundationOne® CDx • Guardant360® CDx • cobas® EGFR Mutation Test v2 • therascreen® EGFR RGQ PCR Kit
    |
    Pozenveo (poziotinib)
    10d
    A case of thymic carcinoma harboring an FGFR3 S249C mutation with durable disease control on lenvatinib. (PubMed, Int Cancer Conf J)
    We herein present a case of 67-year-old man with advanced thymic carcinoma who was treated with carboplatin plus paclitaxel as first-line therapy. Furthermore, the presence of oncogenic mutations in lenvatinib-targeted genes may serve as predictive biomarkers for durable disease control. Given the limited availability of methods to detect oncogenic mutations, including FGFR3, in patients with thymic carcinoma, early implementation of CGP testing-even in the frontline setting-may be warranted in the future.
    Journal
    |
    FGFR3 (Fibroblast growth factor receptor 3)
    |
    FGFR3 mutation
    |
    FoundationOne® CDx
    |
    carboplatin • paclitaxel • Lenvima (lenvatinib)
    10d
    NTRK-rearranged soft tissue sarcoma that originated from the head and neck with a robust response to the TRK inhibitor larotrectinib. (PubMed, Int Cancer Conf J)
    Concurrent comprehensive genome profiling (FoundationOne® CDx) confirmed the LMNA-NTRK1 fusion, and treatment with the TRK inhibitor larotrectinib was started. With larotrectinib treatment, the tumor shrank in size at an early stage, and the response has been maintained for > 2 years.
    Journal
    |
    NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • LMNA (Lamin A/C) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    NTRK positive • NTRK fusion
    |
    FoundationOne® CDx
    |
    Vitrakvi (larotrectinib)
    15d
    Prospective tumour mutation burden and neoantigen profiling predicts immunotherapy response in metastatic melanoma. (PubMed, NPJ Precis Oncol)
    Mutations in NF1 and ROS1 that produce a neoantigen were also linked to improved outcomes. These results support the reproducibility of TMB estimation and highlight the added value of neoantigen profiling in predicting immunotherapy benefits in melanoma.
    Journal • Tumor mutational burden • IO biomarker
    |
    BRAF (B-raf proto-oncogene) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • HRAS (Harvey rat sarcoma viral oncogene homolog) • NF1 (Neurofibromin 1)
    |
    TMB-H • BRAF mutation • PIK3CA mutation • HRAS mutation
    |
    FoundationOne® CDx • TruSight Oncology 500 Assay
    17d
    Fanconi Anemia Complementation Group C Gene (FANCC) Association with Hereditary and Sporadic Renal Tumors. (PubMed, Oncologist)
    Somatic and germline mutations in FANCC occur in an exceedingly small subset of clinically advanced RT but at similar rate to other cancers, and genomic landscape does not appear to be different from RT with wild-type FANCC. Germline testing is warranted, as we see high frequency of germline FANCC mutations.
    Journal • MSi-H Biomarker
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    MSI (Microsatellite instability) • DRD (DNA Repair Deficiency) • FANCC (FA Complementation Group C)
    |
    MSI-H/dMMR • DDR
    |
    FoundationOne® CDx
    21d
    InavoPC: A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=100, Recruiting, Hoffmann-La Roche | Not yet recruiting --> Recruiting
    Enrollment open
    |
    FoundationOne® CDx
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • Itovebi (inavolisib)
    25d
    NCI-2017-02296: Testing Olaparib in Patients With Advanced or Metastatic (Cancer That Has Spread) Bladder Cancer and Other Genitourinary Tumors With DNA-Repair Genetic Changes (clinicaltrials.gov)
    P2, N=60, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date • Tumor mutational burden
    |
    TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • ABL1 (ABL proto-oncogene 1) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • STK11 (Serine/threonine kinase 11) • NPM1 (Nucleophosmin 1) • POLE (DNA Polymerase Epsilon) • CCND1 (Cyclin D1) • BAP1 (BRCA1 Associated Protein 1) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • ATRX (ATRX Chromatin Remodeler) • CHEK2 (Checkpoint kinase 2) • SMARCB1 (SWI/SNF Related, Matrix Associated, Actin Dependent Regulator Of Chromatin, Subfamily B, Member 1) • RAD51 (RAD51 Homolog A) • FANCA (FA Complementation Group A) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • POLD1 (DNA Polymerase Delta 1) • CHEK1 (Checkpoint kinase 1) • BARD1 (BRCA1 Associated RING Domain 1) • FANCL (FA Complementation Group L) • BRD4 (Bromodomain Containing 4) • DOT1L (DOT1 Like Histone Lysine Methyltransferase) • FANCE (FA Complementation Group E) • FANCG (FA Complementation Group G) • IKBKE (Inhibitor Of Nuclear Factor Kappa B Kinase Subunit Epsilon) • FANCC (FA Complementation Group C)
    |
    PALB2 mutation • BRIP1 mutation
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx
    |
    Lynparza (olaparib)
    27d
    Genetic Landscape of Solid Malignant Tumors in a Russian Cohort of Patients. (PubMed, Diagnostics (Basel))
    This study reveals the distinct genomic characteristics of solid tumors in a Russian cohort and confirms the high clinical utility of CGP for identifying actionable targets. Implementing CGP early in the diagnostic process is a necessary step towards realizing personalized treatment strategies for cancer patients.
    Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • APC (APC Regulator Of WNT Signaling Pathway)
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    PD-L1 expression • TP53 mutation • KRAS mutation
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx
    29d
    Genomic Profile and Resistance to Anti-Epidermal Growth Factor Receptor Antibody in RAS-Amplified Colorectal Cancer: A Study Based on a Japanese Cancer Genome Database. (PubMed, JCO Precis Oncol)
    RAS amplification is a rare alteration that may confer resistance to anti-EGFR antibodies. Assessing RAS amplification status may help guide the appropriate use of anti-EGFR antibodies in clinical practice.
    Observational data • Retrospective data • Journal
    |
    EGFR (Epidermal growth factor receptor) • RAS (Rat Sarcoma Virus)
    |
    RAS mutation • RAS wild-type
    |
    FoundationOne® CDx
    |
    Avastin (bevacizumab)
    1m
    COPERNIC: A Study of On-treatment ctDNA Changes in Chemo-refractory Colorectal Cancer Patients (clinicaltrials.gov)
    P=N/A, N=103, Active, not recruiting, Jules Bordet Institute | Recruiting --> Active, not recruiting
    Enrollment closed • Circulating tumor DNA
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx