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    TEST:
    FoundationOne® CDx

    Company:
    Roche
    Type:
    FDA Approved (PMA)
    Related tests:
    10d
    Tumor-Agnostic Landscape with HER2 Amplification in Japan: Real-World Prevalence and Implications for Targeting HER2. (PubMed, Curr Oncol)
    Substantial differences were observed in the mutation frequencies of multiple genes between HER2 amplified and HER2 non-amplified tumors. The results highlight that HER2 amplification extends beyond conventional tumor types and enables the identification, via CGP testing, of non-traditional tumor subsets (cancers other than breast and gastric cancer), including rare cancers, that could be candidates for HER2-targeting therapy such as trastuzumab deruxtecan in Japan.
    Observational data • Retrospective data • Journal • Real-world evidence • Pan tumor
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 amplification
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    FoundationOne® CDx
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    Enhertu (fam-trastuzumab deruxtecan-nxki)
    17d
    Foundation Medicine Expands Existing Collaboration with Bristol Myers Squibb to Develop a Next-Generation Sequencing Companion Diagnostic to Identify Patients with Homozygous MTAP Deletion (Foundation Medicine Press Release)
    ''Foundation Medicine, Inc...today announced an expansion to its collaboration with Bristol Myers Squibb (NYSE: BMY) to develop FoundationOne®CDx as a next-generation sequencing-based companion diagnostic to identify patients with homozygous MTAP deletion in multiple indications for an investigational targeted therapy.''
    Clinical
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    FoundationOne® CDx
    13d
    COTESARC: MEK Inhibitor and a PDL1 Inhibitor Patients With Locally Advanced and/or Metastatic Soft Tissue Sarcoma (clinicaltrials.gov)
    P1/2, N=229, Completed, Centre Leon Berard | Active, not recruiting --> Completed
    Trial completion • Tumor mutational burden
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    TMB (Tumor Mutational Burden)
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    FoundationOne® CDx
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    Tecentriq (atezolizumab) • Cotellic (cobimetinib)
    18d
    CALYPSO: Final Results of Savolitinib and Durvalumab Combination in Metastatic Papillary Renal Cancer. (PubMed, J Clin Oncol)
    Savolitinib plus durvalumab shows OS in MET-driven PRC, supporting the ongoing SAMETA RIII trial (ClinicalTrials.gov identifier: NCT05043090). ctDNA may be a useful predictive biomarker.
    Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
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    PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden)
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    MET mutation
    |
    FoundationOne® CDx
    |
    Imfinzi (durvalumab) • Orpathys (savolitinib)
    19d
    HER-2 gene alterations as biomarker in patients with metastatic colorectal cancer treated with FOLFIRI + cetuximab: findings from the CAPRI-2 GOIM study. (PubMed, ESMO Gastrointest Oncol)
    Of note, 6/7 cases with HER-2 mutations exhibited limited benefit from treatment with FOLFIRI plus cetuximab with PFS inferior to 8 months. Taken together, these results highlight the need to test HER-2 gene alterations for patients with RAS/BRAF V600 WT, MSS mCRC, who are candidates for anti-epidermal growth factor receptor therapies.
    Journal
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    HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene)
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    HER-2 positive • HER-2 overexpression • BRAF mutation • HER-2 amplification • HER-2 negative • BRAF V600 • HER-2 mutation • BRAF wild-type • HER-2 positive + HER-2 overexpression
    |
    FoundationOne® CDx
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    Erbitux (cetuximab) • 5-fluorouracil • irinotecan • leucovorin calcium
    20d
    NEOPRISM-CRC: NEOadjuvant PembRolizumab In Stratified Medicine - ColoRectal Cancer (clinicaltrials.gov)
    P2, N=88, Recruiting, University College, London | Trial completion date: Dec 2028 --> Jul 2029 | Trial primary completion date: Feb 2026 --> Jul 2026
    Trial completion date • Trial primary completion date • Tumor mutational burden • dMMR
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    MSI (Microsatellite instability)
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    MSI-H/dMMR
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx
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    Keytruda (pembrolizumab)
    23d
    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, Suspended, National Cancer Institute (NCI) | Recruiting --> Suspended
    Trial suspension • Tumor mutational burden
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    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)
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    PALB2 mutation • BRIP1 mutation
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    FoundationOne® CDx • FoundationOne® Liquid CDx
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    Lynparza (olaparib)
    24d
    Second Line Treatment Decision as Per Standard of Care or Foundation Medicine in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer. (PubMed, Cancer Med)
    Using FMI data, clinicians were able to direct patients toward clinical trials and to modify SOC clinical management for several NSCLC patients. These results demonstrate the benefit of FMI genomic profiling in identifying actionable driver mutations that would otherwise be missed by SOC methodology. The findings suggest that CGP is a promising and robust tool for improving personalized medicine in NSCLC treatment in Spain.
    Journal
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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    EGFR mutation • BRAF mutation • HER-2 mutation • ALK mutation
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    FoundationOne® CDx • FoundationOne® Liquid CDx
    27d
    Clinicogenomic Landscape and Function of PIK3CA, AKT1, and PTEN Mutations in Breast Cancer. (PubMed, JCO Precis Oncol)
    Here, we present the landscape of PIK3CA, AKT1, and PTEN alterations in, to our knowledge, the largest clinical cohort examined to date. The functional complexity of rare PTEN variants underscores the need for functional validation by tools such as DMS. Rare AKT pathway variants may predict clinical benefit from AKT inhibitors and warrant further clinical investigation.
    Journal
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    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • AKT1 (V-akt murine thymoma viral oncogene homolog 1)
    |
    PIK3CA mutation • PTEN mutation • AKT1 mutation
    |
    FoundationOne® CDx
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    fulvestrant • Truqap (capivasertib)
    1m
    Molecular Profiling across 80,000 Patients with Lung Cancer. (PubMed, J Thorac Oncol)
    This is the largest NSCLC dataset analyzed for biomarker distribution across histologies, age, sex and genetic ancestry. This dataset confirms sufficient enough biomarker prevalence across many histological subtypes of NSCLC, providing reassurance that all NSCLC cases should be considered for biomarker workup.
    Journal • Tumor mutational burden
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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    KRAS G12C • HER-2 amplification • MET amplification • ALK rearrangement • TMB-L • ROS1 rearrangement • RET rearrangement • KRAS G12
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    FoundationOne® CDx
    1m
    Gemcitabine/nab-paclitaxel plus S-1 combination compared with gemcitabine/nab-paclitaxel in advanced pancreatic ductal adenocarcinoma: a retrospective study. (PubMed, Ther Adv Med Oncol)
    No treatment-related mortality was found. The S-1 could be combined with GA as another potential triplet combination treatment option for advanced PDAC.
    Retrospective data • Journal
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    FoundationOne® CDx
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    gemcitabine • albumin-bound paclitaxel • Teysuno (gimeracil/oteracil/tegafur)
    1m
    Limited reliability of H3K27M detection using a commercially available blood-based comprehensive genomic profiling test in patients with diffuse midline gliomas: analysis of the nationwide C-CAT database in Japan. (PubMed, Int J Clin Oncol)
    Our findings indicate a critical limitation of F1 Liquid in detecting the H3K27M and other significant mutations in diffuse midline glioma.
    Journal
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    TP53 (Tumor protein P53) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha) • NF1 (Neurofibromin 1)
    |
    IDH wild-type
    |
    FoundationOne® CDx • Guardant360® CDx • FoundationOne® Liquid CDx • OncoGuide™ NCC Oncopanel System