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    28d
    Tempus announces the clinical launch of p-MSI, its MSI-high predictive algorithm for patients with prostate cancer (Tempus Press Release)
    "Tempus...announces the clinical launch of p-MSI, a digital pathology algorithm using H&E whole slide images that is available with the company’s xT assay for patients with prostate cancer. This offering aims to identify patients who may be more likely than the average patient with prostate cancer to have a tumor that is microsatellite instability high (MSI-H), and therefore potentially eligible for immunotherapy."
    Launch
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    Tempus xT Assay
    1m
    EUS FINE NEEDLE BIOPSY OF SOLID PANCREATIC MASSES IS ADEQUATE FOR COMMERCIAL NEXT GENERATION GENOMIC PROFILING, IDENTIFIES ACTIONABLE MUTATIONS, AND IS NOT IMPROVED WITH RAPID ON-SITE EVALUATION (DDW 2024)
    EUS-FNB with ROSE was associated with significantly more procedure time and needle passes than without ROSE, but produced similar rates of specimen adequacy for genomic analysis. As such, the routine utilization of ROSE may not be warranted for the evaluation of solid pancreatic lesions.
    Biopsy
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    Tempus xT Assay
    2ms
    Molecular profiling of advanced non-small cell lung cancer in response to first-line immune checkpoint inhibitors and/or chemotherapy using multimodal real-world data (AACR 2024)
    Distinct molecular characteristics including tumor immune components and genomic alterations are associated with 1L response in advanced NSCLC. Real-world data analyses provide opportunity to explore distinct mechanisms of therapy resistance and identify potential biomarkers of therapy response for further validation in clinical studies.
    Checkpoint inhibition • Real-world evidence • Clinical • IO biomarker • Real-world • Metastases
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    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • STK11 (Serine/threonine kinase 11) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • NF1 (Neurofibromin 1) • KEAP1 (Kelch Like ECH Associated Protein 1) • TNFA (Tumor Necrosis Factor-Alpha) • CD4 (CD4 Molecule)
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    TP53 mutation • KRAS mutation • NF1 mutation • KEAP1 mutation
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    Tempus xT Assay
    2ms
    A novel combination of tissue-informed, comprehensive genomic profiling (CGP) and non-bespoke blood-based profiling for quantifying circulating tumor DNA (ctDNA) (AACR 2024)
    Here we introduce a novel sensitive and specific tumor-informed, non-bespoke approach for estimating ctDNA TF. Linearity improves with increased panel size and increased variant number. These results suggest that a tumor-informed ctDNA TF can be utilized to improve the sensitivity of existing methods for estimating tumor fraction to help in treatment decisions using Tempus' tissue and liquid comprehensive NGS genomic profiling platform.
    Circulating tumor DNA
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    Tempus xT Assay • Tempus xF Assay
    2ms
    Genetic ancestry associations with pancreatic cancer mutational profiles from a diverse 9,274-patient real-world cohort (AACR 2024)
    Race/ethnicity was associated with RTK changes in both groups, with ASN and HLN having more mutations than NHW, but the associations were not significant after correcting for multiple hypotheses. There was no association of race/ethnicity and TMB .Somatic changes in RTK genes were associated with AMR genetic ancestry; however, despite the relatively large cohort size, these results are modest, suggesting there is not a large somatic mutation component contributing to differences in pancreatic cancer outcomes by ancestry.
    Real-world evidence • Clinical • Tumor mutational burden • Real-world
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • FGFR1 (Fibroblast growth factor receptor 1)
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    Tempus xT Assay
    2ms
    Genetic ancestry associations with prostate adenocarcinoma mutational profiles: New Insights from a diverse 5,959-patient real-world cohort (AACR 2024)
    Lastly, we identified novel positive associations between AMR and driver mutations in PIK3C3A (OR=1.12, p=0.0003) as well as small NS mutations or CNAs in the PI3K/AKT/mTOR pathway genes (OR=1.03, p=0.04). By analyzing a large, diverse real-world cohort and leveraging NGS-inferred genetic ancestry, our study confirms known associations between somatic alterations in PRAD cancer genes and race and ethnicity, while unveiling novel associations in understudied populations of potential significance for understanding disparities in disease outcomes.
    Real-world evidence • Clinical • Real-world
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    TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • ERG (ETS Transcription Factor ERG) • SPOP (Speckle Type BTB/POZ Protein) • FOXA1 (Forkhead Box A1) • TMPRSS2 (Transmembrane serine protease 2) • PIK3C3 (Phosphatidylinositol 3-Kinase Catalytic Subunit Type 3)
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    TP53 mutation • PIK3CA mutation • PTEN mutation • MTOR mutation • SPOP mutation • TMPRSS2-ERG fusion • FOXA1 mutation
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    Tempus xT Assay
    2ms
    Leveraging a comprehensive genomic data library for detecting clonal hematopoiesis in liquid biopsy (AACR 2024)
    A novel classifier trained on multiple orthogonal bioinformatics features can reliably distinguish CH from tumor-derived variants using only liquid biopsy data with high accuracy, including high sensitivity and high specificity.
    Genomic data • Liquid biopsy • Biopsy
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    TP53 (Tumor protein P53) • DNMT3A (DNA methyltransferase 1) • TET2 (Tet Methylcytosine Dioxygenase 2)
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    Tempus xT Assay • Tempus xF+ Panel
    2ms
    Integration of patient-derived tumor organoids and patient clinical multimodal data to investigate the role of organoids in predicting treatment response (AACR 2024)
    These results suggest that PDOs may serve as a powerful tool for predicting patient response to treatment and aid the development of new therapies.
    Clinical
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    Tempus xT Assay
    2ms
    Clinicopathologic and Genomic Characterization of High-Grade Invasive Solid Papillary Carcinoma of the Breast (USCAP 2024)
    High-grade SPC are occasionally encountered and not well-characterized. Similar to their lower-grade counterparts, approximately half show NE differentiation. However, in contrast, these cases frequently have more aggressive features such as necrosis, LVI/nodal metastases and alterations in cellular proliferation pathways and tumor suppressor transcription factors.
    Clinical • Tumor mutational burden
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • PTEN (Phosphatase and tensin homolog) • ARID1A (AT-rich interaction domain 1A) • NRG1 (Neuregulin 1) • MLH1 (MutL homolog 1) • KMT2C (Lysine Methyltransferase 2C) • GATA3 (GATA binding protein 3) • SYP (Synaptophysin) • INSM1 (INSM Transcriptional Repressor 1)
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    PIK3CA mutation • NRG1 fusion • NRG1 mutation • NRG1 fusion
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    Tempus xT Assay • Oncotype DX Breast Recurrence Score®Test
    2ms
    Clinicopathologic and Genomic Characterization of High-Grade Invasive Solid Papillary Carcinoma of the Breast (USCAP 2024)
    High-grade SPC are occasionally encountered and not well-characterized. Similar to their lower-grade counterparts, approximately half show NE differentiation. However, in contrast, these cases frequently have more aggressive features such as necrosis, LVI/nodal metastases and alterations in cellular proliferation pathways and tumor suppressor transcription factors.
    Clinical • Tumor mutational burden
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • PTEN (Phosphatase and tensin homolog) • ARID1A (AT-rich interaction domain 1A) • NRG1 (Neuregulin 1) • MLH1 (MutL homolog 1) • KMT2C (Lysine Methyltransferase 2C) • GATA3 (GATA binding protein 3) • SYP (Synaptophysin) • INSM1 (INSM Transcriptional Repressor 1)
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    PIK3CA mutation • NRG1 fusion • NRG1 mutation • NRG1 fusion
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    Tempus xT Assay • Oncotype DX Breast Recurrence Score®Test
    2ms
    Clinicopathologic and Genomic Characterization of Breast Histiocytoid Carcinomas (USCAP 2024)
    HC is predominantly lobular phenotype but rare cases can exhibit E-cadherin expression. With ER low+/triple-negative status and low proliferation index, HC may not be responsive to chemotherapy or endocrine therapy, yet frequently recurs or metastasizes. Targeting the PI3K pathway or AR is a potential therapeutic strategy.
    Clinical
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    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) • PTEN (Phosphatase and tensin homolog) • AR (Androgen receptor) • NF1 (Neurofibromin 1) • CDH1 (Cadherin 1) • PIK3R1 (Phosphoinositide-3-Kinase Regulatory Subunit 1)
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    HER-2 negative • NF1 mutation • CDH1 expression • CDH1 mutation
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    Tempus xT Assay
    3ms
    Evaluation of the somatic and immunologic landscapes of primary and metastatic cervical cancer to better inform future clinical trial development (SGO 2024)
    Molecular and immune profiling of primary and metastatic lesions in this cervical cancer cohort revealed similar phenotypes, suggesting that predominant biologic pathways are preserved. Further interrogation of the molecular landscape across paired and serial samples is needed to better inform the development of novel therapies.
    Clinical • Tumor mutational burden • PD(L)-1 Biomarker • MSi-H Biomarker • IO biomarker • Metastases
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    PD-L1 (Programmed death ligand 1) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • ARID1A (AT-rich interaction domain 1A) • CD8 (cluster of differentiation 8) • MAP2K2 (Mitogen-activated protein kinase kinase 2) • CD4 (CD4 Molecule)
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    TMB-H
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    Tempus xT Assay
    4ms
    Imputation of race and ethnicity categories using genetic ancestry from real-world genomic testing data. (PubMed, Pac Symp Biocomput)
    Analyzing de-identified data from over 100,000 cancer patients sequenced with the Tempus xT panel, we demonstrate that both methods outperform existing geolocation and surname-based methods, with the machine learning approach achieving high recall (range: 0.859-0.993) and precision (range: 0.932-0.981) across four mutually exclusive race and ethnicity categories. This work presents a novel pathway to enhance RWD utility in studying racial disparities in healthcare.
    Real-world evidence • Journal • Real-world
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    Tempus xT Assay
    4ms
    Tempus announces participation in National Cancer Institute’s ComboMATCH trials (Tempus Press Release)
    "Tempus...announced its participation in the National Cancer Institute’s (NCI) ComboMATCH group of precision medicine trials. The ComboMATCH trials aim to pair patients with a therapy that has the potential to manage their tumor and help assist physicians in devising more effective treatment strategies for individuals with locally advanced or advanced solid tumors. Tempus is one of the NCI-designated commercial laboratories for the initiative...Oncologists at participating ComboMATCH clinical sites can leverage their patients’ results from Tempus’ signature xT assay to determine their potential suitability for the program’s treatment trials."
    Clinical
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    Tempus xT Assay
    4ms
    Comparative genomic analysis of PIK3R1-mutated and wild-type breast cancers. (PubMed)
    This is the largest investigation of the PIK3R1 mutational landscape in breast cancer patients (n = 6,009). PIK3R1 mutations were more common in triple-negative breast cancer (~ 6%) than in HER2 + or HER2-/HR + disease (approximately 2%). While alterations in the PI3K/AKT pathway are often actionable in HER2-/HR + breast cancer, our study suggests that PIK3R1 could be an important target in TNBC as well.
    Journal • Tumor mutational burden
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    Tempus xT Assay
    4ms
    Tempus Sculptor Study: Small Cell Lung Cancer (SCLC) Observational Study (clinicaltrials.gov)
    P=N/A; N=50; Recruiting; Sponsor:Tempus Labs
    Trial completion date • Trial primary completion date • Circulating tumor DNA
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    PD-L1 (Programmed death ligand 1)
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    Tempus xT Assay
    4ms
    Describing the genomic landscape of bladder cancer histologic subtypes. (ASCO-GU 2024)
    Distinct genomic alteration patterns were found among different histologic subtypes of bladder cancer and conventional UC. Assessing the genomic landscape of bladder cancer can help identify potential ‘actionable’ targets and biomarkers, and better inform clinical trial designs. Limitations include lack of clinical data annotation, tumor heterogeneity and retrospective study nature.
    Tumor mutational burden • PD(L)-1 Biomarker • MSi-H Biomarker • IO biomarker
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    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • FGFR2 (Fibroblast growth factor receptor 2) • FGFR3 (Fibroblast growth factor receptor 3)
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    PD-L1 expression • TMB-H • MSI-H/dMMR • HER-2 amplification • FGFR2 fusion
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    Tempus xT Assay
    5ms
    RNA-Based Homologous Recombination Deficiency Signature Detects Homologous Recombination Deficiency-RNA+ Patients With and Without Homologous Recombination Repair Gene Pathogenic Alterations in Men With Prostate Cancer. (PubMed, JCO Precis Oncol)
    Use of an RNA-based HRD signature significantly expands the fraction of patients with prostate cancer who may derive benefit from poly (ADP-ribose) polymerase inhibitors (PARPis) compared with using HRR gene mutations alone. Further studies are needed to evaluate functional HRD significance and inform future usage as a predictive biomarker for PARPi selection.
    Journal • PARP Biomarker • BRCA Biomarker
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    TP53 (Tumor protein P53) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • ATM (ATM serine/threonine kinase) • HRD (Homologous Recombination Deficiency)
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    HRD • HRD signature
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    Tempus xT Assay
    5ms
    Genomic and immune landscape of biliary tract cancers with ARID1A, PBRM1, and BAP1 alterations. (ASCO-GI 2024)
    This is the largest known data set exploring the genomic and immune landscape of BTC with ARID1A, PBRM1 and BAP1 alterations. Macrophages were the dominant immune cell TME and may be a target of interest. Co-alteration profile is distinct between ARID1A- vs PBRM1- and/or BAP1-altered BTC.
    Tumor mutational burden • PD(L)-1 Biomarker • MSi-H Biomarker • IO biomarker
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    PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • NRAS (Neuroblastoma RAS viral oncogene homolog) • MSI (Microsatellite instability) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • ARID1A (AT-rich interaction domain 1A) • CD8 (cluster of differentiation 8) • PBRM1 (Polybromo 1) • BAP1 (BRCA1 Associated Protein 1) • SMAD4 (SMAD family member 4) • CD4 (CD4 Molecule) • ARID2 (AT-Rich Interaction Domain 2)
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    MSI-H/dMMR • PBRM1 mutation • BAP1 mutation
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    Tempus xT Assay • Tempus xR
    5ms
    Comprehensive clinico-molecular profile and efficacy of anti-HER2 therapy for HER2-amplified biliary tract cancer. (ASCO-GI 2024)
    HER2 amplifications were found in 10% of advanced BTC and did not represent an independent predictive factor for OS. Of clinical significance, patients with HER2-amplified BTC derive a significant benefit from anti-HER2 therapy.
    Clinical
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    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TP53 (Tumor protein P53)
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    TP53 mutation • BRAF mutation • HER-2 amplification • BRAF amplification • TP53 amplification
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    FoundationOne® CDx • Guardant360® CDx • FoundationOne® Liquid CDx • Tempus xT Assay
    5ms
    A Retrospective Review Assessing the Development of Myelodysplastic Syndromes in Patients with Plasma Cell Dyscrasias (ASH 2023)
    The identification of both morphologic and molecular abnormalities in our cohort may inform therapeutic considerations as well as vigilance for the discovery or evolution of myeloid disorders during follow-up , in particular when unexpected cytopenias or new clinical concerns emerge. We expect to design future prospective studies, based on our observations, to further inform of the risk of myeloid disorders in our plasma cell disorder patient cohorts, as well as understand its impact on therapies such as immunomodulatory agents, alkylators and/or autologous stem cell transplant.
    Retrospective data • Review
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    DNMT3A (DNA methyltransferase 1) • SF3B1 (Splicing Factor 3b Subunit 1) • ASXL1 (ASXL Transcriptional Regulator 1) • TET2 (Tet Methylcytosine Dioxygenase 2)
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    DNMT3A mutation • ASXL1 mutation • SF3B1 mutation
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    Tempus xT Assay
    5ms
    Tempus announces Medicare coverage for Tempus|xT across solid tumor and hematologic malignancies (Tempus Press Release)
    "Tempus...announced that Palmetto GBA, a Medicare Administrative Contractor, and the Molecular Diagnostics Services Program (MolDx) has approved coverage for Tempus|xT, Tempus’ 648-gene DNA sequencing panel, for use in solid tumor and hematologic malignancies, performed in Tempus’ CAP/CLIA laboratory located in Research Triangle Park in North Carolina."
    Medicare • Reimbursement
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    Tempus xT Assay
    6ms
    Mapping inter- and intra-tumor heterogeneity in Ductal Carcinoma in situ and invasive breast cancer using integrative multi-omic profiling (SABCS 2023)
    Integrative multi-modal analysis helps us better understand tumor progression at multiple levels of biomolecular dysregulation and shows the complex interplay among genome alterations, gene expression reprogramming and tissue morphology. Such approaches may yield future biomarker signatures that better encapsulate the diverse mechanisms by which DCIS lesions evolve.
    MCL1 (Myeloid cell leukemia 1) • TCF4 (Transcription Factor 4) • HSF4 (Heat Shock Transcription Factor 4)
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    Tempus xT Assay
    6ms
    ESR1 mutations drive resistance to CDK4/6 inhibitors in ER+ Breast Cancer. (SABCS 2023)
    When treated with palbociclib + fulvestrant or palbociclib + estrogen-free medium (mimicking estrogen suppression in patients treated with aromatase inhibitors), cells harboring the Y537S and D538G mutations displayed an 11.2 to 46.9-fold increase in the IC50 of palbociclib. ESR1 mutations are enriched following treatment with CDK4/6i in a cohort of 3,958 patients with ER+/HER2- metastatic breast cancer. Mutations in ESR1 in ER+ breast cancer cells directly promote resistance to CDK4/6i alone or CDK4/6i + antiestrogens in vitro and in vivo.
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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    HER-2 negative • HER-2 mutation • ER mutation • ER Y537S • ER D538G • ESR1 mutation • CDK4 mutation
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    Tempus xT Assay • Tempus xF Assay
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    Ibrance (palbociclib) • fulvestrant
    6ms
    Real-world clinical genomics study of HR+/HER2- metastatic breast cancers treated by CDK4/6i plus endocrine therapies revealed a drug resistant tumor segment characterized by ER independence (SABCS 2023)
    Conclusions Our real-world clinical genomics study identified a comprehensive list of biomarkers associated with resistance to CDK4/6i plus ET and estimated patient prevalence for these markers in the post-treatment setting. Integrated and machine-learning analyses identified a subset of aggressive tumors with estrogen independence characteristics that are implicated in CDK4/6i resistance and suggested new therapeutic strategies.
    Real-world evidence • Clinical • Genomic study • BRCA Biomarker • Real-world • Metastases
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • TP53 (Tumor protein P53) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • RB1 (RB Transcriptional Corepressor 1) • CCNE1 (Cyclin E1) • CDK4 (Cyclin-dependent kinase 4) • CDK2 (Cyclin-dependent kinase 2)
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    TP53 mutation • HR positive • HER-2 negative • RB1 mutation • MYC expression • PGR expression • CCNE1 expression
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    Tempus xT Assay
    6ms
    The Landscape of Somatic Genetic Alterations in Breast Cancers from Carriers of Germline Pathogenic Variants in DNA-repair Genes (SABCS 2023)
    The observed differences in the frequencies of CCND1, ESR1, PIK3CA, TP53, and other key genetic alterations between incidental hereditary and sporadic breast cancer highlight the unique tumor biology of breast cancer in germline PV carriers and have significant implications for understanding tumorigenesis and identifying therapeutic strategies for the management of hereditary breast cancer.
    BRCA Biomarker
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    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) • FGFR1 (Fibroblast growth factor receptor 1) • CCND1 (Cyclin D1) • PALB2 (Partner and localizer of BRCA2) • CHEK2 (Checkpoint kinase 2)
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    TP53 mutation • HER-2 amplification • HER-2 negative • ATM mutation • ER mutation • ESR1 mutation
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    Tempus xT Assay
    7ms
    Pathway Mutations are Associated with Clinical Outcomes in Localized Pancreatic Cancer Treated with Neoadjuvant Chemoradiation Followed by Surgery. (PubMed, Int J Radiat Oncol Biol Phys)
    For pancreatic cancer patients that undergo neoadjuvant chemoradiation followed by oncologic resection of the primary tumor, mutations in key biological pathways are associated with OS and PFS. Characterizing the importance of common pathway mutations may become increasingly valuable to help categorize less commonly mutated genes assayed by NGS.
    Journal • Clinical data • Surgery
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    Tempus xT Assay
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    gemcitabine • 5-fluorouracil
    7ms
    PPARG amplification is associated with lack of response to anti-PD1 in muscle-invasive urothelial cancer (SITC 2023)
    FX-909, a first-in-class covalent PPARG inverse agonist that will be evaluated in a Ph1 trial this year, will offer an opportunity to investigate the impact of PPARG inhibition on the TME of MIUC patients. FX-909 combination with ICI therapy potentially provides a ‘one-two punch’ strategy to overcome resistance to immunotherapy in MIUC patients with high PPARG expression.
    PD(L)-1 Biomarker • IO biomarker
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    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • PPARG (Peroxisome Proliferator Activated Receptor Gamma)
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    PD-L1 expression • PD-L1 negative • PD-L1-L
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    PD-L1 IHC 22C3 pharmDx • Tempus xT Assay
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    FX-909
    7ms
    A multi-modal, pan-cancer atlas of tumor-immune states across primary and metastatic disease using a large, real-world database (SITC 2023)
    Conclusions In the largest pan-cancer analysis to date, significant differences in tumor immune states were observed by primary and metastatic sites, and by indication, with important implications for IO-treatment strategies. These data provide valuable and timely insights for IO research, where simultaneous assessment of molecular, immune, and clinical traits is required.
    Real-world evidence • Clinical • Tumor mutational burden • IO biomarker • Pan tumor • Real-world • Metastases
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    Tempus xT Assay
    7ms
    Interrogating real world tumor-infiltrating T-cell repertoires to identify antigen enriched TCRs in a large pan-cancer clinical cohort (SITC 2023)
    Analysis of this resource – encompassing a diverse collection of cancer types, HLA genotypes, and mutational/viral contexts – revealed a subset of TCRs enriched with allele-specific neo-antigens. This dataset is a valuable resource for TCR therapeutic discovery, and can help identify naturally occuring TCRs that may minimize on-target, off-tumor toxicity.
    Real-world evidence • Clinical • Pan tumor • Real-world
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    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53)
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    KRAS Q61H
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    Tempus xT Assay • Tempus xR
    7ms
    Novel EWSR-PBX3 chromosomal rearrangement in a melanoma (ASDP 2023)
    Surveillance imaging in the year after diagnosis remained negative. Poster type: Poster Defense
    Tumor mutational burden
    |
    TMB (Tumor Mutational Burden) • EWSR1 (EWS RNA Binding Protein 1) • SOX10 (SRY-Box 10) • MLANA (Melan-A) • TP63 (Tumor protein 63) • GFAP (Glial Fibrillary Acidic Protein) • PBX3 (PBX Homeobox 3)
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    BRAF V600E
    |
    Tempus xT Assay
    8ms
    A retrospective assessment of biologically relevant genomic perturbations and variants of unknown significance in a cohort of plasma cell disorder at our institution; a single center experience (IMW 2023)
    We herein report the genomic profile of plasma cell disorders using a commercially available assay at the time of diagnosis. Higher TMB and number of VUS per patient trended towards malignant disease states, suggesting that estimation of the known and unknown genomic burden can inform transformation potential. Pathway analysis of VUS genes can also be informative of their biological relevance if truly differentially expressed.
    Retrospective data • Tumor mutational burden
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    KRAS (KRAS proto-oncogene GTPase) • TMB (Tumor Mutational Burden) • DNMT3A (DNA methyltransferase 1) • NOTCH1 (Notch 1) • KMT2D (Lysine Methyltransferase 2D) • ARID1B (AT-Rich Interaction Domain 1B)
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    KRAS mutation • TMB-H • DNMT3A mutation
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    Tempus xT Assay
    8ms
    Early outcomes and therapy modification strategies in Multiple Myeloma patients treated with teclistamab, CD3XBCMA BITE; a single center experience. (IMW 2023)
    In our limited patient dataset, 6 (66.7%) patients had achieved an early best response of PR or higher, consistent with clinical trial data. Despite treatment frequency modification, two patients achieved a CR with one patient achieving a stringent CR at the 3-month evaluation. Further studies are needed to assess response adapted treatment frequency modification as well as study genomic perturbations that can alter the function of immune cells (T cells) and impact response to BITE.
    Clinical
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    DNMT3A (DNA methyltransferase 1) • CD8 (cluster of differentiation 8) • TET2 (Tet Methylcytosine Dioxygenase 2) • CHEK2 (Checkpoint kinase 2) • CD4 (CD4 Molecule)
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    DNMT3A mutation • TET2 mutation • CHEK2 mutation
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    clonoSEQ • Tempus xT Assay
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    Tecvayli (teclistamab-cqyv)
    8ms
    Thrombotic Significance in Plasma Cell Disorders: Do associated clonal hematopoiesis of indeterminate potential (CHIP) mutations increase the risk? (IMW 2023)
    In this analysis of 64 patients, we identified a proportion of patients with CHIP mutations that affect platelet function and/or count as well as thrombo-embolic events around the time of their diagnosis or later however a clear association could not be established between them. Further studies are needed to inform of the thrombotic risk and the initiation of prophylactic anticoagulation in these disorders.
    DNMT3A (DNA methyltransferase 1) • JAK2 (Janus kinase 2)
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    Tempus xT Assay
    8ms
    Novel BAP1 Mutation Arising in the Salivary Duct Carcinoma Component of an Intracapsular Carcinoma Ex Pleomorphic Adenoma (CAP 2023)
    In conclusion, we present the first reported case of a BAP1 mutation arising in CXPA and immunohistochemical evidence of BAP1 loss limited to the SDC component of the neoplasm. As BAP1 mutations have prognostic and genetic implications, additional evaluation for BAP1 status in CXPA and SDC as well as correlation with clinical outcomes is warranted and will be performed in future studies.
    BRCA Biomarker
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • BRCA2 (Breast cancer 2, early onset) • AR (Androgen receptor) • BAP1 (BRCA1 Associated Protein 1) • PLAG1 (PLAG1 Zinc Finger) • FBXO32 (F-Box Protein 32)
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    PIK3CA mutation • BAP1 mutation
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    Tempus xT Assay
    8ms
    Pathway Mutations are Associated with Clinical Outcomes in Localized Pancreatic Cancer Treated with Neoadjuvant Chemoradiation Followed By Surgery (ASTRO 2023)
    Patients were typically treated with neoadjuvant chemotherapy (either 5-fluorouracil-based or gemcitabine-based) followed by radiation. For pancreatic cancer patients that undergo neoadjuvant chemoradiation followed by oncologic resection of the primary tumor, mutations in key biological pathways are associated with OS and PFS. Characterizing the importance of common pathway mutations may become increasingly valuable to help categorize less commonly mutated genes assayed by NGS.
    Clinical data • Clinical • Surgery
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    Tempus xT Assay
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    gemcitabine • 5-fluorouracil
    8ms
    GENOMIC CHARACTERIZATION OF CHONDROSARCOMA: A RARE SARCOMA WITH CLINICAL RESPONSES TO IMMUNE CHECKPOINT INHIBITION (CTOS 2023)
    These findings reinforce current therapeutic efforts to target IDH signaling in chondrosarcoma and provide insight into why some subpopulations of patients may respond to immune checkpoint inhibitors. Biomarker-driven trials are needed to understand the significance and potential applications of these results in clinical practice.
    Checkpoint inhibition • Clinical • Tumor mutational burden • PD(L)-1 Biomarker • MSi-H Biomarker • IO biomarker
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    PD-L1 (Programmed death ligand 1) • TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • MTAP (Methylthioadenosine Phosphorylase) • PDGFRB (Platelet Derived Growth Factor Receptor Beta) • KMT2D (Lysine Methyltransferase 2D) • LRP1B (LDL Receptor Related Protein 1B) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B) • KMT2C (Lysine Methyltransferase 2C) • RBM10 (RNA Binding Motif Protein 10) • EMSY (EMSY Transcriptional Repressor BRCA2 Interacting) • PRKDC (Protein Kinase, DNA-Activated, Catalytic Subunit) • HEY1 (Hes Related Family BHLH Transcription Factor With YRPW Motif 1) • NCOA2 (Nuclear Receptor Coactivator 2)
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    PD-L1 expression • MSI-H/dMMR • IDH2 mutation
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    Tempus xT Assay
    8ms
    M2 MACROPHAGE INFILTRATION IS ASSOCIATED WITH EARLY DISEASE RECURRENCE FOLLOWING CURATIVE INTENT SURGICAL RESECTION IN SOFT-TISSUE SARCOMAS (CTOS 2023)
    Prior studies have associated STS with cold immune environments; however, with the high infiltration present in a small number of tumors in this dataset, it is possible that there may still be a spectrum of immune environments in STS. We identified a M2 macrophage dominant, pro-tumor TIME in high-risk disease. Taken together, this data may help to identify patients receiving curative intent surgical resections for intra-abdominal STS who are at the highest risk of recurrence, while presenting the potential target for immunotherapy in a subset of high-risk STS.
    IO biomarker
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    Tempus xT Assay
    9ms
    Comparative analysis of the tumor immune microenvironment (TIME) in primary and metastatic sites of microsatellite stable (MSS) and microsatellite instability-high (MSI) colorectal cancer (ESMO 2023)
    Conclusions MSI LM and PM have a more favorable TIME than respective MSS metastases, explaining the discordance in response to checkpoint inhibitors (CPI) and reported CPI benefits in MSI cases across all metastatic sites. MSS LuM have a comparable TIME to MSI metastatic sites, explaining the recently reported benefits from CPI therapy in this group.
    Microsatellite instability • Tumor mutational burden • PD(L)-1 Biomarker • MSi-H Biomarker • IO biomarker • Metastases
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    PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
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    PD-L1 expression • MSI-H/dMMR
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    Tempus xT Assay
    9ms
    Real-world data analysis of genomic profiling-matched targeted therapy outcomes in patients with fusion-positive NSCLC (ESMO 2023)
    More importantly, CGP-matched guideline-recommended treatment is associated with improved rwOS. Future studies are needed to understand the gap in compliance with matched targeted therapy.
    Real-world evidence • Clinical • Real-world
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    ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
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    ALK positive • RET fusion • ALK fusion • ROS1 fusion • ALK-ROS1 fusion • NTRK fusion
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    Tempus xT Assay
    9ms
    Genomic characterization of sporadic MET amplified non-small cell lung cancer (NSCLC) and association with real-world outcomes (ESMO 2023)
    Conclusions The majority of treatment-naive patients with sporadic MET CNAs are EGFR mutation-negative and enriched with biomarkers that are predictive of immune therapy benefit (PD-L1-H and TMB-H). Future clinical trials evaluating MET targeted therapy should account for this genomic heterogeneity and immunogenic therapeutic potential.
    Real-world evidence • Clinical • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker • Real-world
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    TMB (Tumor Mutational Burden) • MET (MET proto-oncogene, receptor tyrosine kinase)
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    TMB-H • MET amplification • MET exon 14 mutation • MET mutation
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    Tempus xT Assay
    9ms
    ALK fusion detection by RNA next-generation sequencing (NGS) compared to DNA in a large, real-world non-small cell lung cancer (NSCLC) dataset (ESMO 2023)
    This increase is likely to translate to a larger number of patients matched to and receiving targeted therapy. Consequently, RNA NGS should be considered for more widespread adoption in the clinic.
    Real-world evidence • Clinical • Next-generation sequencing • Real-world
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    ALK (Anaplastic lymphoma kinase) • EML4 (EMAP Like 4) • KIF5B (Kinesin Family Member 5B) • KLC1 (Kinesin light chain 1)
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    ALK rearrangement • EML4-ALK fusion • ALK fusion
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    Tempus xT Assay