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6d
EVOLVE-BDT: Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies (clinicaltrials.gov)
P2, N=700, Not yet recruiting, UNC Lineberger Comprehensive Cancer Center
New P2 trial
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Tempus xR
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everolimus • capecitabine • Verzenio (abemaciclib)
2ms
Impact of RAS/BRAF V600E mutations on the tumor immune microenvironment in mismatch repair deficient /microsatellite instability colorectal cancers. (PubMed, Clin Cancer Res)
Our data suggest that MSI/dMMR CRCs harboring RASmut are less immunogenic and TiME contains a lower inflammatory profile than wild-type or BRAFV600E tumors. Further analysis and validation are required to confirm these findings.
Journal • Mismatch repair • Tumor mutational burden • Microsatellite instability • PD(L)-1 Biomarker • IO biomarker • dMMR
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PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • CD8 (cluster of differentiation 8) • RAS (Rat Sarcoma Virus)
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BRAF V600E • MSI-H/dMMR • BRAF V600 • BRAF wild-type • RAS mutation • RAS wild-type • BRAF V600 wild-type
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Tempus xT Assay • Tempus xR
4ms
Tempus Receives U.S. FDA 510(k) Clearance for Tempus xR IVD, its RNA NGS In Vitro Diagnostic Device (Tempus Press Release)
"Tempus AI, Inc...today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its RNA-based Tempus xR IVD device. xR IVD will be offered as a life sciences tool to support drug development programs."
FDA approval
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Tempus xR
6ms
Comprehensive Comparison of Somatic, Germline, and Immune Cell Profiles in Upper Tract and Bladder Urothelial Carcinoma. (PubMed, JCO Precis Oncol)
By comprehensive molecular characterization of UC, we observed distinct genomic alterations and tumor microenvironment patterns in UTUC and UCB. Further research is warranted to elucidate the clinical implications of these findings. We compared the genetic and immune features of upper tract and bladder cancers. Our study found key differences that could affect treatment decisions, such as specific gene changes and immune markers. These insights may help doctors personalize therapies and improve patient care.
Clinical • Retrospective data • Journal • Tumor mutational burden • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker
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HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • FGFR3 (Fibroblast growth factor receptor 3) • RB1 (RB Transcriptional Corepressor 1) • MLH1 (MutL homolog 1) • KMT2D (Lysine Methyltransferase 2D) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B) • PMS2 (PMS1 protein homolog 2) • CD4 (CD4 Molecule) • CDKN1A (Cyclin-dependent kinase inhibitor 1A)
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MSI-H/dMMR
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Tempus xT Assay • Tempus xR
8ms
Journal • Checkpoint inhibition • Real-world evidence • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
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PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability)
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Tempus xT Assay • Tempus xR
11ms
DNA damage repair gene alterations influence the tumor immune microenvironment in advanced non-small cell lung cancer. (PubMed, Lung Cancer)
Among patients with metastatic NSCLC, 37% present with DDRmt tumors characterized by higher TMB, frequency of MSI-H, and changes in immune cell infiltrates. These findings provide insight into the immunogenic landscape of DDR-altered NSCLC and may inform biomarker selection and therapeutic strategies.
Journal • Tumor mutational burden • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker
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TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • CD8 (cluster of differentiation 8)
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TMB-H • MSI-H/dMMR
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Tempus xT Assay • Tempus xR
1year
A Comprehensive Whole Genome Sequencing Assay Provides Robust Characterization of Clinically Relevant Genomic Alterations across Myeloid Malignancies Concordant with Matched Results from Targeted DNA, Whole Transcriptome RNA and Cytogenetic Profiling (ASH 2024)
Additionally, WGS can identify unique SVs that may be missed by conventional methods and enables clinical benefits such as HLA typing for potential transplant (alloHCT) or diagnostic refinement by retroviral insertion (e.g. HTLV-1). These findings demonstrate the potential for integration of WGS into clinical practice to enhance personalized treatment strategies.
Clinical • Discordant • Whole genome sequencing
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FLT3 (Fms-related tyrosine kinase 3) • RUNX1 (RUNX Family Transcription Factor 1) • RUNX1T1 (RUNX1 Partner Transcriptional Co-Repressor 1)
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Tempus xT Assay • Tempus xR
1year
Tempus Announces Nine Abstracts Accepted for Presentation at the 2024 Society for Immunotherapy of Cancer Annual Meeting (Businesswire)
"This study aimed to predict patient outcomes to immune checkpoint inhibitors (ICI) by developing an integrated DNA/RNA ICI biomarker. A de-identified pan-cancer cohort from the Tempus multimodal real-world database was utilized to develop and validate the Immune Profile Score (IPS) algorithm that leverages Tempus xT (DNA sequencing) and xR (RNA sequencing). The researchers found that IPS status can be used to stratify patient cohorts and prognosticate ICI-treatment response....The team analyzed real-world imaging patterns from a cohort of 4,147 advanced cancer patients treated with immune checkpoint inhibitors (ICI) across five solid tumor types....Incorporating these patterns into a microsimulation model, the team demonstrated that using the molecular biomarker in conjunction with CT imaging provided substantial cost savings and reduced inappropriate therapy compared to imaging alone, with the most benefit observed in small cell lung cancer (SCLC) treated with ICI-chemotherapy."
Real-world evidence • Clinical data
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Tempus xT Assay • Tempus xR
1year
Low-level Aurora kinase A (AURKA) amplification as a novel personalized biomarker of CDK4/6 inhibitor (CDK4/6i) resistance in patients with hormone-receptor positive (HR+) metastatic breast cancer (SABCS 2024)
In this large, real-world translational research cohort of pts with HR+ MBC, low-level AURKA copy number gain was common. These data report the first evidence suggesting that low-level amplifications in AURKA, which conventional sequencing platforms miss, can provoke meaningful changes in gene expression as assessed via RNA transcriptome analysis. Further, low-level AURKA amplifications predict inferior outcomes on CDK4/6i for pts with HR+ MBC.
Clinical • Metastases
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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) • RB1 (RB Transcriptional Corepressor 1) • CDK4 (Cyclin-dependent kinase 4) • CDK6 (Cyclin-dependent kinase 6) • AURKA (Aurora kinase A)
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HR positive • HER-2 negative • RB1 mutation
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Tempus xT Assay • Tempus xR
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alisertib (MLN8237)
over1year
CLINICAL VALIDATION OF A NOVEL MULTI-OMIC ALGORITHM FOR STRATIFYING OUTCOMES IN A REAL-WORLD COHORT OF METASTATIC SOLID CANCER PATIENTS TREATED WITH IMMUNE CHECKPOINT INHIBITORS (SITC 2024)
"Ethics Approval Tempus AI, Inc. has been granted an IRB exemption (Advarra Pro00072742) permitting the use of de-identified clinical, molecular, and multimodal data in order to derive or capture results, insights, or discoveries."
Clinical • Checkpoint inhibition • Real-world evidence
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PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden)
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PD-L1 negative • TMB-L
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Tempus xT Assay • Tempus xR
over1year
Tumor immune microenvironment characterization from pre- and post-dose tumors collected from a phase 1/2 study of NDI-101150, a hematopoietic progenitor kinase 1 (HPK1) inhibitor (SITC 2024)
Background NDI-101150, an oral, selective, small molecule inhibitor of HPK1, is being studied as monotherapy and in combination with pembrolizumab. Ethics Approval This multicenter study was approved by the relevant Ethics Board at each study site. All participants gave informed consent before taking part.
P1/2 data • PD(L)-1 Biomarker • IO biomarker
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CD8 (cluster of differentiation 8) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C) • GZMB (Granzyme B)
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Tempus xR
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Keytruda (pembrolizumab)
over1year
NUT Thyroid Carcinoma: a Case Report of Rare Malignancy (ATA 2024)
"Given updated diagnosis, definitive concurrent chemoradiation (CRT, 7000 cGy in 35 fractions) with weekly cisplatin was administered...NUT IHC staining was negative, as has been reported due to tissue fixation. With inconsistent diagnostic tools for an already rare malignancy, our case highlights the role early NGS can play in diagnosis of unique cases that can alter management."
Late-breaking abstract • Clinical • Case report
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NSD3 (Nuclear Receptor Binding SET Domain Protein 3)
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Tempus xR
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cisplatin