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3d
Phase II Trial of First-Line Durvalumab and Chemotherapy in Patients With Extra-Pulmonary Small Cell Carcinoma. (PubMed, JTO Clin Res Rep)
This single-arm phase II trial enrolled patients with EPSCC to investigate the activity of first-line durvalumab (1500 mg every 3 wk) and 4 to 6 cycles of chemotherapy (either cisplatin or carboplatin) with etoposide, followed by maintenance durvalumab 1500 mg every 4 weeks until disease progression. This study reveals that durvalumab plus chemotherapy is safe and has some activity in rare small cell cancers outside the lung, but benefits are modest and short lived. Current treatment remains largely chemotherapy based, highlighting the urgent need for larger, collaborative research efforts to find more effective options for these patients.
P2 data • Journal • Tumor mutational burden • PD(L)-1 Biomarker
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TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • RB1 (RB Transcriptional Corepressor 1)
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TP53 mutation
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TruSight Oncology 500 Assay • TruSight Tumor 170 Assay
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cisplatin • carboplatin • Imfinzi (durvalumab) • etoposide IV
3ms
MET fusions and splicing variants in glioma: a landscape integrating clinical, pathological, and survival features. (PubMed, J Pathol Clin Res)
ZM fusion was associated with a worse prognosis in both astrocytoma (OS p < 0.001, PFS p < 0.001) and glioblastoma (OS, p = 0.252; PFS, p = 0.010) patients. We highlight the utmost relevance of ZM fusion as an adverse prognostic factor in astrocytoma (11/382, 2.88%) and glioblastoma grade 4 (11/401, 2.74%) patients and suggest that the grading of these tumors should be refined.
Journal
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MET (MET proto-oncogene, receptor tyrosine kinase) • PTPRZ1 (Protein Tyrosine Phosphatase Receptor Type Z1)
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MET expression
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TruSight Tumor 170 Assay
7ms
A signal-seeking phase 2 study of tremelimumab in advanced cancers with high tumour mutational burden. (PubMed, NPJ Precis Oncol)
Seven tremelimumab-related serious adverse events (grade 2-3) occurred in 5 patients. While the primary PFS6 endpoint was not met, there were two durable objective responses in rare cancers and a favourable change in disease trajectory for an additional five patients based on TTP ratio 1.3.
P2 data • Journal • Tumor mutational burden
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TMB (Tumor Mutational Burden)
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TMB-H
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FoundationOne® CDx • TruSight Oncology 500 Assay • TruSight Tumor 170 Assay
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Imjudo (tremelimumab-actl)
10ms
Development and Performance Validation of a Comprehensive Liquid Biopsy Genotyping Panel for Pan-cancer Analysis. (PubMed, Ann Lab Med)
Its sensitivity for low-frequency variants enables real-time treatment adaptation, supporting precision oncology. Its comprehensive design is particularly valuable for challenging diagnoses and clonal evolution monitoring.
Journal • Liquid biopsy • Pan tumor
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TruSight Oncology 500 Assay • TruSight Tumor 170 Assay
10ms
Real-World Evaluation of Microsatellite Instability Detection via Targeted NGS Panels in Routine Molecular Diagnostics. (PubMed, Int J Mol Sci)
Within this range, the integration of TMB into the MSI classification workflow significantly improves diagnostic accuracy. For samples that remain inconclusive, orthogonal confirmation using MSI-PCR is advised to ensure accurate MSI classification.
Journal • HEOR • Real-world evidence • Next-generation sequencing • Tumor mutational burden • Microsatellite instability • MSi-H Biomarker • IO biomarker
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MSI (Microsatellite instability)
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MSI-H/dMMR
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TruSight Oncology 500 Assay • TruSight Tumor 170 Assay
over1year
Implementation of Liquid Biopsy for Clinical Somatic Variant Testing of Solid Tumors (AMP 2024)
This study demonstrates the feasibility of implementing cfDNA tumor profiling from blood in our laboratory. This assay provides sensitive detection of genomic variants in a cfDNA sample . Initially, the reporting will be performed for 64 genes covering only SNVs and insertions/deletions.
Clinical • Liquid biopsy • Biopsy
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CDKN2A (Cyclin Dependent Kinase Inhibitor 2A)
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TruSight Tumor 170 Assay
over1year
Novel Nanopore-Based Copy Number Analysis for Ultrafast Renal Tumor Classification (AMP 2024)
In this study, we applied the iSCORED pipeline for ultrafast, genome-wide CNV information of renal tumors with results showing complete concordance with established CNV analysis methods. This method could facilitate pathological diagnosis and potentially inform targeted treatment in less than 2 hours. Future directions include expanding analyzed tumor types and integrating methylation classification into the pipeline.
OncoScan™ CNV Assay • TruSight Tumor 170 Assay
over1year
Homologous recombination deficiency (HRD) in biliary carcinomas: clinical significance and correlation with platinum response (DGHO 2024)
In second-line treatment, no difference between an Irinotecan-based regimen and re-exposure to platinum-based agents (12.36 vs 10.13 months; HR 0.92; P=0.85) could be observed (HR 1.45; P=0.35). HRRm BTC patients showed a potential advantage in OS following platinum-based first-line chemotherapy, presumably attributed to enhanced opportunities for targetable co-alterations. Further investigation is needed to delineate HRD in the context of personalizing systemic therapies of BTC.
Clinical
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HRD (Homologous Recombination Deficiency) • ARID1A (AT-rich interaction domain 1A) • BAP1 (BRCA1 Associated Protein 1)
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HRD
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FoundationOne® CDx • Archer® FusionPlex® Comprehensive Thyroid & Lung (CTL) Kit • TruSight Tumor 170 Assay
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irinotecan
over1year
Analytical and Clinical Validation of the Oncomine Dx Target Test to Assess HER2 Mutation Status in Tumor Tissue Samples From Patients With Non-Small Cell Lung Cancer Treated With Trastuzumab Deruxtecan in the DESTINY-Lung01 and DESTINY-Lung02 Studies. (PubMed, Arch Pathol Lab Med)
Response duration was 12.0 and 9.3 months for patients identified by the ODxT Test and CTAs, respectively, in DESTINY-Lung01. The ODxT Test detected HER2 mutations in NSCLC with high analytical and clinical accuracy and identified HER2m populations with response rates similar to populations identified by CTAs, supporting clinical utility of the ODxT Test to inform treatment decisions for HER2m NSCLC.
Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 mutation
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Oncomine™ Dx Target Test • TruSight Tumor 170 Assay
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Enhertu (fam-trastuzumab deruxtecan-nxki)
almost2years
Trial completion • Metastases
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CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
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FoundationOne® CDx • TruSight Oncology 500 Assay • TruSight Tumor 170 Assay
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Imjudo (tremelimumab-actl)
2years
Homologous recombination repair (HRR) deficiency in biliary tract cancers: Clinical implications in subsequent therapy lines and correlation with platinum sensitivity (ESMO-GI 2024)
A trend for a clinical benefit of second-line therapy with re-exposure to platinum-based agents as compared to irinotecan-based regimens was observed (HR= 0.79, 95%CI 0.34-1.8, P= 0.56)... Platinum-based chemotherapy associates with more favorable outcomes in HRRm BTC patients. Further investigation is needed to delineate HRD in the context of personalizing systemic therapies of BTC.
Clinical
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HRD (Homologous Recombination Deficiency)
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FoundationOne® CDx • AmoyDx® HRD Focus Panel • Archer® FusionPlex® Comprehensive Thyroid & Lung (CTL) Kit • TruSight Tumor 170 Assay
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irinotecan
over2years
First NGS-based companion diagnostic to aid in selecting non-small cell lung cancer patients with ERBB2 (HER2) activating mutations for treatment with trastuzumab deruxtecan (AACR 2024)
The 6 AV studies met the necessary product requirements and acceptance criteria to detect clinical samples with ERBB2 mutations. Additionally, the CV study clinical accuracy and clinical efficacy results demonstrated the safety and effectiveness of the use of the ODxTT in FFPE samples as an aid to identify NSCLC patients eligible for treatment with the Daiichi Sankyo lung cancer therapeutic T-DXd.
Clinical • Next-generation sequencing • Companion diagnostic
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 mutation • MET mutation
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Oncomine™ Dx Target Test • TruSight Tumor 170 Assay
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Enhertu (fam-trastuzumab deruxtecan-nxki)