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    TEST:
    FoundationOne® Liquid CDx

    Company:
    Roche
    Type:
    FDA Approved
    Related tests:
    5d
    ExoGLIE: Clinical Relevance of Detecting Molecular Abnormalities in Glial Tumor Exosomes (clinicaltrials.gov)
    P=N/A, N=60, Recruiting, University Hospital, Limoges | Not yet recruiting --> Recruiting
    Enrollment open
    |
    FoundationOne® Liquid CDx
    28d
    Analysis of cancer multigene panel testing for osteosarcoma in pediatric and adults using the center for cancer genomics and advanced therapeutics database in Japan. (PubMed)
    "Precision medicine for rare tumors still poses challenges. In this Japanese cohort, 42.2 % of high-grade OSs had potentially actionable alterations per CKDB. Concurrent gene amplifications of KIT, KDR, and PDGFRA at 4q12, and VEGFA and CCND3 at 6p12-21, might offer promising therapeutic options for patients with recurrent/metastatic OS resistant to conventional chemotherapy."
    Journal
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx • MSK-IMPACT • OncoGuide™ NCC Oncopanel System
    1m
    U.S. Food and Drug Administration Approves FoundationOne Liquid CDx as a Companion Diagnostic for TEPMETKO (tepotinib) to Identify Patients with MET Exon 14 Skipping Alterations in Non-Small Cell Lung Cancer (Businesswire)
    "Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne Liquid CDx to be used as a companion diagnostic for TEPMETKO (tepotinib) developed by EMD Serono, the healthcare business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada....FoundationOne Liquid CDx is the first FDA-approved companion diagnostic to identify patients who may be eligible for TEPMETKO."
    FDA approval
    |
    FoundationOne® Liquid CDx
    |
    Tepmetko (tepotinib)
    1m
    Biomarker Analysis of phase II CAVE2 GOIM study of the combination of avelumab plus cetuximab as rechallenge strategy in pre-treated RAS/BRAF wild type metastatic colorectal cancer patients (AIOM 2024)
    These preliminary findings suggest that evaluation of in vitro cytotoxicity together with CD107a expression in mCRC patients derived PBMC could be a useful tool to identify early responders after only 8 weeks of treatment with cetuximab plus avelumab. In addition, we aim to further investigate the potential role of CCL5 secreted by peripheral immune cells and its cut-off as a predictive biomarker of mCRC progression in a larger cohort of patients.
    Clinical • P2 data • PD(L)-1 Biomarker • Metastases
    |
    BRAF (B-raf proto-oncogene) • RAS (Rat Sarcoma Virus) • LAMP1 (Lysosomal Associated Membrane Protein 1)
    |
    BRAF wild-type • LAMP1 expression
    |
    FoundationOne® Liquid CDx
    |
    Erbitux (cetuximab) • Bavencio (avelumab)
    1m
    Genomic profiling and clinical utility of circulating tumor DNA in metastatic prostate cancer: SCRUM-Japan MONSTAR SCREEN project. (PubMed, BJC Rep)
    This study revealed valuable findings for the clinical care of metastatic prostate cancer. Especially, predictive factors such as HRR defect in mCSPC should be validated in the future.
    Journal • Tumor mutational burden • Circulating tumor DNA • Metastases
    |
    TMB (Tumor Mutational Burden) • HRD (Homologous Recombination Deficiency)
    |
    AR mutation • AR amplification
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx
    1m
    Circulating Tumor DNA (ctDNA) Testing in TALAPRO-2 Complements Tumor Testing to Gain a Greater Understanding of the Metastatic Castration-Resistant Prostate Cancer (mCRPC) Mutational Landscape (AMP 2024)
    Introduction: TALAPRO-2 (NCT03395197) demonstrated that first-line talazoparib + enzalutamide significantly improved radiographic progression-free survival versus placebo + enzalutamide for patients with metastatic castration-resistant prostate cancer (mCRPC). These results are supportive of the ability of F1LCDx to sensitively detect alterations in HRR genes, and the likely overall modest impact of CHiP in calling HRR gene alteration status in this study. These results support the complementary benefits of ctDNA testing to tumor tissue testing in assessing current disease alteration status, particularly AR.
    BRCA Biomarker • PARP Biomarker • Circulating tumor DNA • Metastases
    |
    BRCA2 (Breast cancer 2, early onset) • AR (Androgen receptor) • HRD (Homologous Recombination Deficiency) • DNMT3A (DNA methyltransferase 1) • TET2 (Tet Methylcytosine Dioxygenase 2) • CDK12 (Cyclin dependent kinase 12) • ERG (ETS Transcription Factor ERG) • TMPRSS2 (Transmembrane serine protease 2)
    |
    BRCA2 mutation
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx
    |
    Talzenna (talazoparib) • Xtandi (enzalutamide)
    1m
    ctDNA Tumor Fraction Quantifies Tumor-Derived DNA in FoundationOne Liquid CDx (F1LCDx) (AMP 2024)
    F1LCDx TF accurately quantifies ctDNA fraction in LBx samples. Patients with elevated TF (≥1% TF) have high concordance with TBx results, providing increased confidence in LBx negative results, potentially identifying patients where reflex to TBx may be less valuable, for example, in a trial enrollment setting.
    Circulating tumor DNA
    |
    FoundationOne® Liquid CDx
    1m
    Analysis of circulating tumor DNA in treatment-naive patients with metastatic renal cell carcinoma (EMUC 2024)
    Conclusions To our knowledge, we report the most sensitive analysis in terms of ctDNA detection in mRCC pt compared to published cohorts. Longitudinal ctDNA assessments could help picture disease evolution on therapy and help refine strategies.
    Clinical • IO biomarker • Circulating tumor DNA • Metastases
    |
    TP53 (Tumor protein P53) • PTEN (Phosphatase and tensin homolog) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • PBRM1 (Polybromo 1) • BAP1 (BRCA1 Associated Protein 1) • KMT2D (Lysine Methyltransferase 2D) • CREBBP (CREB binding protein) • KDM6A (Lysine Demethylase 6A) • SETD2 (SET Domain Containing 2, Histone Lysine Methyltransferase) • EP300 (E1A binding protein p300) • STING (stimulator of interferon response cGAMP interactor 1) • KDM5C (Lysine Demethylase 5C)
    |
    TP53 mutation • PBRM1 mutation
    |
    FoundationOne® Liquid CDx
    1m
    Detection of circulating tumor DNA (ctDNA) in cerebrospinal fluid (CSF) in patients with glioblastoma treated in phase I clinical trial. (SNO 2024)
    Conclusion : We showed in this small cohort of patients that detection of CSF-ctDNA is technically feasible. The type of panel used might be optimized for this population especially to monitor patients as a potential surrogate biomarker for treatment response.
    Clinical • P1 data • Circulating tumor DNA
    |
    EGFR (Epidermal growth factor receptor) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • MTAP (Methylthioadenosine Phosphorylase)
    |
    EGFR mutation • EGFR amplification • MTAP deletion
    |
    FoundationOne® Liquid CDx
    1m
    The Current Status of Comprehensive Genomic Profiling in the Management of Metastatic Castration-Resistant Prostate Cancer: A Study from a Cooperative Hospital for Cancer Genomic Medicine in Japan. (PubMed, J Nippon Med Sch)
    Our results offer insights into the real-world application of CGP testing for patients with mCRPC at a cooperative hospital for cancer genomic medicine in Japan. Thus, urologists require a comprehensive understanding of the current status of CGP testing to enhance mCRPC management.
    Journal • BRCA Biomarker • Metastases
    |
    TP53 (Tumor protein P53) • BRCA2 (Breast cancer 2, early onset)
    |
    BRCA2 mutation
    |
    FoundationOne® Liquid CDx
    2ms
    Serial circulating tumor DNA (ctDNA) assessment to predict treatment response and identify genomic evolution in patients with metastatic breast cancer (mBC). (SABCS 2024)
    Decrease in TF, but not maxVAF, at 1-2 weeks after starting next therapy is correlated with clinical response at time of restaging and can provide an early assessment of treatment response. Genomic evolution with both emerging and disappearing alterations, including in genes clinically actionable in breast cancer as well as genes likely associated with CH, was frequently identified by serial liquid biopsies, both at time of progression and while on treatment.
    Clinical • BRCA Biomarker • Circulating tumor DNA • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • PTEN (Phosphatase and tensin homolog) • DNMT3A (DNA methyltransferase 1) • PALB2 (Partner and localizer of BRCA2)
    |
    TP53 mutation • PIK3CA mutation • ATM mutation • PTEN mutation • PALB2 mutation
    |
    FoundationOne® Liquid CDx
    2ms
    Utility of Plasma Circulating DNA Tumor Fraction in Bone-Only Metastatic Breast Cancer: A Real-world Outcomes Study (SABCS 2024)
    BO MBC Pts are as likely to have detectable circulating tumor DNA as MBC Pts with V mets, – particularly prior to 1st line of therapy when ctDNA levels would be expected to be lowest and in multivariate modeling controlling for clinicopathologic factors. There are no associations between V vs. BO mets and TF groups, and BO Pts with TF 10%.
    Clinical • Real-world evidence • Real-world • Metastases
    |
    ER (Estrogen receptor) • ALK (Anaplastic lymphoma kinase)
    |
    FoundationOne® Liquid CDx
    2ms
    Circulating Tumor DNA as a Prognostic Biomarker for CDK 4/6 Inhibitor Therapy in Metastatic Breast Cancer (SABCS 2024)
    In this study, we analyzed a subset of patients from the Dallas Metastatic Breast Cancer Study comprised of patients with HR+, HER2 non-amplified, mBC who underwent treatment with a CDK4/6 inhibitor (palbociclib, ribociclib, abemaciclib) and ET, became resistant to therapy, and had ctDNA testing (n=102). There is an urgent need to develop predictive biomarkers that capture real-time changes in tumor biology. Tissue analyses from patients resistant to CDK4/6 inhibitors have demonstrated a 14%-28% expression of CCNE1, 16% of MYC mutations, and 9%-10% expression of RB mutations. In our study, we observe a lower rate of detection in ctDNA of each gene.
    Circulating tumor DNA • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • MYC (V-myc avian myelocytomatosis viral oncogene homolog) • RB1 (RB Transcriptional Corepressor 1) • CCNE1 (Cyclin E1)
    |
    HR positive • RB1 mutation • MYC expression • MYC mutation • CCNE1 expression • HER-2 amplification + HR-positive
    |
    FoundationOne® Liquid CDx • Tempus xF Assay
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib)
    2ms
    PD-L1 Upregulation in Circulating Tumor Associated Cells Predicts for clinical outcomes in a phase I/II clinical trial using SV-BR-1-GM vaccine with the check point inhibitor retifanlimab in Metastatic Breast Cancer Patients, an Interim Analysis (SABCS 2024)
    SV-BR-1-GM treatment includes low pre-dose cyclophosphamide, intradermal inoculation of ~20 million irradiated SV-BR-1-GM cells, post-dose local interferon-α with cycles and an anti-PD-1 inhibitor (retifanlimib), with cycles every 3 weeks. In an interim analysis of heavily treated mBC patient population, we observed that treatment with the SV-BR-1-GM regimen was associated with decreases in the presence of CTCs and CAMLs in 38% of patients, which significantly correlated with better PFS and trended for better OS within 2 years. Further, SV-BR-1-GM therapy appeared to upregulate PD-L1 in n=13 patients which appeared to have better responses to combination treatment with the anti-PD-1 check point inhibitor retifanlimab.
    Clinical • Clinical data • P1/2 data • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 expression
    |
    FoundationOne® Liquid CDx
    |
    cyclophosphamide • Zynyz (retifanlimab-dlwr) • Bria-IMT (SV-BR-1-GM)
    2ms
    PLATON - Platform for Analyzing Targetable Tumor Mutations (Pilot-study) (clinicaltrials.gov)
    P=N/A, N=400, Completed, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Recruiting --> Completed
    Trial completion • Tumor mutational burden • IO biomarker
    |
    TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx
    2ms
    Detection of genomic alterations in liquid biopsies from patients with non-small cell lung cancer using FoundationOne Liquid CDx: a cost-effectiveness analysis. (PubMed, J Med Econ)
    Various limitations inherent to cost-effectiveness analyses were described. LB with F1L CDx test is a cost-effective strategy in Spain for patients with advanced NSCLC without tissue sample available for molecular diagnosis, improving the personalized treatment of these patients.
    HEOR • Journal • Cost-effectiveness • Cost effectiveness • Liquid biopsy • Biopsy
    |
    FoundationOne® Liquid CDx
    2ms
    Clinical utility of liquid-based comprehensive genomic profiling (CGP) in gastrointestinal stromal tumors (GIST) (DGHO 2024)
    55% (42/77) of liquid samples with a KIT -driver mutation had a co-occurring imatinib-resistant alteration, and a minority of cases harbored non- KIT mechanisms of resistance such as FGFR2 fusion, BRAF or EGFR alterations... Known driver and TKI-resistant mutations are identified in liquid biopsies of patients with GIST, with high concordance to tissue in the presence of elevated TF. Liquid biopsy may be valuable in the molecular classification of GIST during the medical management of advanced disease.
    Clinical • Stroma
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • FGFR2 (Fibroblast growth factor receptor 2) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha) • NF1 (Neurofibromin 1)
    |
    KIT mutation • FGFR2 mutation • FGFR2 fusion • NF1 mutation • KIT exon 13 mutation • KIT exon 17 mutation
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx
    |
    imatinib
    2ms
    Exploratory analyses of homologous recombination repair (HRR) gene subgroups and potential associations with secondary efficacy endpoints in the HRR-deficient population of TALAPRO-2 (TP-2) (DGHO 2024)
    Introduction: TP-2 (NCT03395197) demonstrated statistically significant improvement in rPFS with 1L talazoparib (TALA) + enzalutamide (ENZA) in patients (pts) with mCRPC with and without HRR gene alterations (HRRm; prospectively determined). Broad differential efficacy benefit was evident for TALA+ENZA vs PBO+ENZA across multiple molecular subgroups and was most pronounced for the BRCA1 - PALB2 - BRCA2 axis and CDK12.
    Clinical • BRCA Biomarker • PARP Biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • PALB2 (Partner and localizer of BRCA2) • CDK12 (Cyclin dependent kinase 12) • BRCA (Breast cancer early onset)
    |
    BRCA2 mutation
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx
    |
    Talzenna (talazoparib) • Xtandi (enzalutamide)
    2ms
    U.S. Food and Drug Administration Approves FoundationOneLiquid CDx as a Companion Diagnostic for Itovebi (inavolisib) to Identify Patients with Hormone Receptor-Positive, HER2-Negative Breast Cancer with a PIK3CA Mutation (Businesswire)
    "Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneLiquid CDx to be used as a companion diagnostic for Itovebi (inavolisib) in combination with palbociclib (Ibrance) and fulvestrant, a therapy developed by Genentech, a member of the Roche group, which has been contemporaneously approved for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy."
    FDA event
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    FoundationOne® Liquid CDx
    |
    Itovebi (inavolisib)
    2ms
    Real-world pan-tumor comprehensive genomic profiling sample adequacy and success rates in tissue and liquid specimens. (PubMed, Oncologist)
    In conclusion, except in CNS tumors or when accounting for liquid TF, success rates of F1CDx and F1LCDx are equivalently high. These results may guide informed decision on when to pursue tissue vs liquid testing of patients with cancer.
    Real-world evidence • Journal • Pan tumor • Real-world
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx
    3ms
    Rationale and Design of the COPERNIC Trial: A Study of On-treatment ctDNA Changes in Chemo-refractory Colorectal Cancer Patients. (PubMed, Clin Colorectal Cancer)
    P=N/A; Recruitment is open in 13 centres across Belgium and France. The study is registered with clinicaltrials.gov (NCT05487248).
    Journal • Circulating tumor DNA
    |
    FoundationOne® Liquid CDx • FoundationOne®Monitor
    3ms
    Foundation Medicine awarded contract by the U.S. Department of Veterans Affairs to provide tumor molecular profiling to Veterans with cancer (Foundation Medicine Press Release)
    "Foundation Medicine, Inc...announced it was awarded its second consecutive, five-year contract by the U.S. Department of Veterans Affairs (VA) to provide tumor molecular profiling tests and services to eligible Veterans living with cancer as part of the VA’s National Precision Oncology Program. The national contract covers Foundation Medicine’s tissue-based test FoundationOne®CDx, liquid-based test FoundationOne®Liquid CDx, tissue-based RNA sequencing test FoundationOne®RNA and FoundationOne®Heme for hematologic malignancies."
    Clinical
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx • FoundationOne® Heme CDx • FoundationOne®RNA
    3ms
    Prediction of undetectable circulating tumor DNA by comprehensive genomic profiling assay in metastatic prostate cancer: the SCRUM-Japan MONSTAR SCREEN project. (PubMed, World J Urol)
    An algorithm created in this study is helpful in determining when to undertake comprehensive genomic profiling assay using blood.
    Journal • Circulating tumor DNA • Metastases
    |
    FoundationOne® Liquid CDx
    3ms
    Nationwide survey of the secondary findings in cancer genomic profiling: survey including liquid biopsy. (PubMed)
    The percentage of cases leading to confirmatory tests has gradually increased, although challenges such as insurance coverage limitations and varied understanding of SF among patients and healthcare providers persist. With the increasing use of whole-genome analysis, our findings will provide valuable insights into establishing an effective SF disclosure system.
    Journal • Liquid biopsy • Biopsy
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    FoundationOne® CDx • FoundationOne® Liquid CDx
    3ms
    Characterising the genomic landscape of advanced non-squamous NSCLC of Chinese: A territory-wide study in Hong Kong (ESMO Asia 2024)
    Providing valuable insights into the mutational landscape of NSCLC. These findings have significant clinical implications in Hong Kong and globally.
    Tumor mutational burden • IO biomarker • Metastases
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden)
    |
    TP53 mutation • KRAS mutation • EGFR mutation • TMB-H • KRAS G12C • EGFR L858R • HER-2 mutation • EGFR exon 19 deletion • ALK fusion • KRAS G12 • KRAS deletion
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx
    4ms
    U.S. Food and Drug Administration Approves FoundationOne CDx and FoundationOne Liquid CDx as Companion Diagnostics for Lynparza (olaparib) in Combination with Abiraterone for Patients with BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer (Businesswire)
    "Foundation Medicine...announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne CDx and FoundationOne Liquid CDx to be used as companion diagnostics for AstraZeneca’s and Merck’s (known as MSD outside of the United States and Canada) Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). This decision from the FDA follows the approval of FoundationOne CDx for Lynparza to identify mCRPC patients with homologous recombination repair (HRR) gene alterations and the approval of FoundationOne Liquid CDx for Lynparza to identify patients with BRCA1, BRCA2 and/or ATM alterations in mCRPC."
    FDA approval
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx
    |
    Lynparza (olaparib)
    4ms
    Sequential therapy for hereditary leiomyomatosis and renal cell cancer-associated renal cell carcinoma: a case report and report of a new family pedigree. (PubMed, Oxf Med Case Reports)
    Here, we report a patient with HLRCC-associated RCC treated with sequential therapy, including ipilimumab plus nivolumab combination and cabozantinib, after diagnosis of HLRCC-associated RCC using FoundationOne Liquid CDx and single-site analysis. We also investigated familial FH mutations and describe a new family pedigree for HLRCC.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    FH (Fumarate Hydratase)
    |
    FoundationOne® Liquid CDx
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Cabometyx (cabozantinib tablet)
    4ms
    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; Trial completion date: Aug 2024 --> Dec 2025 | Trial primary completion date: Aug 2024 --> Dec 2025
    Trial completion date • Trial primary completion date • Tumor mutational burden • Metastases
    |
    TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • ABL1 (ABL proto-oncogene 1) • MSI (Microsatellite instability) • STK11 (Serine/threonine kinase 11) • NPM1 (Nucleophosmin 1) • POLE (DNA Polymerase Epsilon) • CCND1 (Cyclin D1) • 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) • 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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    FoundationOne® CDx • FoundationOne® Liquid CDx
    |
    Lynparza (olaparib)
    4ms
    The Rome trial from histology to target: The road to personalize targeted therapy and immunotherapy (ESMO 2024)
    P2 | "The most frequently assigned TTs were IPI/NIVO (37%), ipatasertib (16%), pemigatinib (8%), TDM1 (8%), and atezo/ipatasertib (6%). The incidence of G≥3 AEs was 35% for TT and 40% for SoC. Conclusions The ROME Trial demonstrated that a mutational-based treatment approach based on the MTB discussion of CGP results may significantly improve ORR and PFS compared to SoC in pretreated patients with metastatic solid tumors, particularly with immunotherapy."
    Late-breaking abstract
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • FGFR (Fibroblast Growth Factor Receptor)
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx
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    Pemazyre (pemigatinib) • ipatasertib (RG7440)
    4ms
    NEOPRISM-CRC: NEOadjuvant PembRolizumab In Stratified Medicine - ColoRectal Cancer (clinicaltrials.gov)
    P2; N=32 --> 78 | Trial completion date: Sep 2027 --> Dec 2028 | Trial primary completion date: Sep 2024 --> Feb 2026
    Trial completion date • Trial primary completion date • Enrollment change • Tumor mutational burden
    |
    MSI (Microsatellite instability)
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx
    |
    Keytruda (pembrolizumab)
    5ms
    Synchronous Double Primary Lung Adenocarcinomas With EGFR L858R Point Mutation and MET Exon 14 Skipping Mutation. (PubMed)
    We made a diagnosis of another primary adenocarcinoma from the left S1+2 nodule (cT1bN3M0, c-stage IIIB) with MET mutation, and changed osimertinib to capmatinib. The temporal and spatial heterogeneity reinforces the need for primary tissue biopsy if dual primaries are suspected. Temporally distinct liquid biopsies, not standard at present, may be considered.
    Journal
    |
    FoundationOne® Liquid CDx • Oncomine™ Dx Target Test
    |
    Tagrisso (osimertinib) • Tabrecta (capmatinib)
    5ms
    Profound ctDNA and radiological responses after 2 cycles of avelumab in a metastatic Merkel cell carcinoma of the head and neck. (PubMed, Oral Oncol)
    Avelumab may achieve rapid and major responses in metastatic MCC. Our study demonstrates that ctDNA mirrors radiological responses and may serve as an ideal companion for diagnosis and disease monitoring in MCC.
    Journal • PD(L)-1 Biomarker • IO biomarker • Circulating tumor DNA • Metastases
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    FoundationOne® CDx • FoundationOne® Liquid CDx
    |
    Bavencio (avelumab)
    5ms
    Tissue- and liquid-biopsy based NGS profiling in advanced non-small-cell lung cancer in a real-world setting: the IMMINENT study. (PubMed, Front Oncol)
    Conditional three-year survival probabilities increased over time for patients profiled at initial diagnosis and exceeded those of individuals tested later in their clinical history after 12 months. This study confirms that NGS-based molecular profiling of aNSCLC on tissue or blood samples offers valuable predictive and prognostic insights.
    Real-world evidence • Journal • Tumor mutational burden • Liquid biopsy • Next-generation sequencing • Real-world • Metastases • Biopsy
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    KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • STK11 (Serine/threonine kinase 11) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • RB1 (RB Transcriptional Corepressor 1) • KEAP1 (Kelch Like ECH Associated Protein 1) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B)
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx
    5ms
    Feasibility of Comprehensive Genomic Profiling for Advanced NSCLC in Public Healthcare System - The Hong Kong Experience (IASLC-WCLC 2024)
    Conclusions : The introduction of routine CGP testing in workflow of management of advanced NSCLC into public healthcare setting yields improvement in detection rate of actionable mutations at comparable turnaround time and a high success rate. While a median of additional 10 minutes is required for the additional explanation, thoracic oncologists are willing to adapt routine CGP in management of advanced NSCLC and most find the additional information provided helpful to patient management.
    Metastases
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx
    5ms
    Clinical validity of plasma DNA testing to identify BRCA-mutated (BRCA+) patients in the MAGNITUDE study (ESMO 2024)
    Background: Niraparib plus abiraterone acetate with prednisone (NIRA+AAP) is indicated for BRCA+ metastatic castration-resistant prostate cancer (mCRPC) patients (pts), as identified by an approved companion diagnostic tissue test, Foundation One®CDx (F1CDx®). Clinical efficacy of NIRA+AAP was consistent in F1LCDx-identified BRCA pts compared to CTA and tissue identified pts, demonstrating the potential clinical utility of the F1LCDx plasma assay as a non-invasive test.
    Clinical • PARP Biomarker • BRCA Biomarker • BRCA Companion diagnostic • PARP Companion diagnostic
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    BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx
    |
    Zejula (niraparib) • abiraterone acetate
    5ms
    Molecular characterization from IMfirst: Atezolizumab plus chemotherapy in extensive-stage small cell lung cancer (ES-SCLC) in Spain (ESMO 2024)
    Here, we characterized the mutational landscape at baseline and progression of SCLC patients (pts) from IMfirst (EudraCT: 2019-002784-10), a phase IIIb study that evaluates the safety of atezolizumab + carboplatin/cisplatin + etoposide in ES-SCLC in Spain. Tissue and liquid biopsies were analyzed by FoundationONE®CDx and FoundationOne®Liquid, respectively. This exploratory analysis provides a detailed profiling of the molecular alterations found in ES-SCLC pts from IMfirst, assessed by solid and liquid biopsies at baseline and progression. The potential prognostic value of the identified genes should be further validated.
    Tumor mutational burden • PD(L)-1 Biomarker
    |
    TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • PTEN (Phosphatase and tensin homolog) • DNMT3A (DNA methyltransferase 1) • RB1 (RB Transcriptional Corepressor 1) • NOTCH1 (Notch 1) • MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • KMT2D (Lysine Methyltransferase 2D) • CHEK2 (Checkpoint kinase 2) • NOTCH3 (Notch Receptor 3)
    |
    TMB-H • PTEN mutation • DNMT3A mutation • TMB-L
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx
    |
    cisplatin • Tecentriq (atezolizumab) • carboplatin • etoposide IV
    5ms
    Sequential ctDNA profiling in patients with advanced non-small cell lung cancer: An interim analysis of the COPE randomized study (ESMO 2024)
    This study highlights serial ctDNA profiling's benefits for managing advanced NSCLC, providing real-time genetic data. It offers predictive insights as potential imaging substitutes, enables dynamic treatment adjustments, and identifies resistance to therapies.
    Clinical • Circulating tumor DNA • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase) • STK11 (Serine/threonine kinase 11) • MAP2K1 (Mitogen-activated protein kinase kinase 1) • RB1 (RB Transcriptional Corepressor 1) • SMARCA4 (SWI/SNF related, matrix associated, actin dependent regulator of chromatin, subfamily A, member 4) • STAG2 (Stromal Antigen 2) • NBN (Nibrin Nijmegen Breakage Syndrome 1 (Nibrin))
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    STK11 mutation • STAG2 mutation • NBN mutation
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    FoundationOne® CDx • FoundationOne® Liquid CDx
    5ms
    Detection of circulating tumor DNA (ctDNA) in cerebrospinal fluid (CSF) in patients with glioblastoma treated in phase I clinical trial (ESMO 2024)
    We showed in this small cohort of patients that detection of CSF-ctDNA is technically feasible in clinical practice. The type of panel used might be optimized for this population especially to monitor patients as a potential surrogate biomarker for treatment response.
    P1 data • Clinical • Circulating tumor DNA
    |
    EGFR (Epidermal growth factor receptor) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • MTAP (Methylthioadenosine Phosphorylase)
    |
    EGFR amplification • MTAP deletion
    |
    FoundationOne® Liquid CDx
    5ms
    Clonal haematopoiesis of indeterminate potential (CHIP) might mislead interpretation of ATM and CHEK2 alterations detected on liquid biopsies (ESMO 2024)
    CHIP was highly prevalent in cancer patients likely due to genotoxic stress and ageing. The rate of mutations was dependant on cancer types and treatment context. The prevalence of mutated DNA repair genes CHEK2 and ATM was increased post-cisplatin exposure.
    PARP Biomarker • Liquid biopsy • Biopsy
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    ATM (ATM serine/threonine kinase) • DNMT3A (DNA methyltransferase 1) • JAK2 (Janus kinase 2) • TET2 (Tet Methylcytosine Dioxygenase 2) • CHEK2 (Checkpoint kinase 2)
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    ATM mutation • CHEK2 mutation
    |
    FoundationOne® Liquid CDx
    |
    cisplatin
    5ms
    Gene rearrangements, actionability and access to precision medicine: Results from the ARCAGEN study (ESMO 2024)
    Rearrangements in rare cancers have at least, a similar rate as in common cancers and can be targeted. However, despite identification of the alterations, treatment access remains limited.
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • FGFR2 (Fibroblast growth factor receptor 2) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    FGFR2 fusion • ALK fusion
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx • FoundationOne® Heme CDx
    5ms
    Interim analysis of prospective observational study to evaluate the impact of cancer gene panel tests on treatment decision making in metastatic or recurrent breast cancer in Japan: JBCRG-C07 REIWA study (ESMO 2024)
    The present results indicate a higher rate of accessibility for MT in breast cancer, and the impact of F1CDx/F1LCDx on treatment decision-making was significant. Prognostic analysis will be performed at the end of the observation period (planned for two years).
    Observational data • Clinical • Metastases
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    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden)
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    TMB-H • HER-2 mutation
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx
    5ms
    Assessing molecular characteristics in a large cohort of anal squamous cell carcinoma patients (ESMO 2024)
    Systematic molecular profiling of these pts's tumors will improve our understanding in this rare entity. In a significant percentage of cases, it could provide the access to molecules targeting actionable MA.
    Clinical • Tumor mutational burden
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    TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • PTEN (Phosphatase and tensin homolog) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • KMT2D (Lysine Methyltransferase 2D) • FBXW7 (F-Box And WD Repeat Domain Containing 7)
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    TP53 mutation • CDKN2A negative
    |
    FoundationOne® CDx • FoundationOne® Liquid CDx