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2d
A Phase 1/2 Study of D3S-002 as Monotherapy or Combination Therapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations (clinicaltrials.gov)
P1/2, N=67, Recruiting, D3 Bio (Wuxi) Co., Ltd | Active, not recruiting --> Recruiting | Trial completion date: Apr 2028 --> Aug 2028 | Trial primary completion date: Apr 2028 --> Aug 2028
Enrollment open • Trial completion date • Trial primary completion date • First-in-human
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EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2)
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BRAF V600E • EGFR mutation • KRAS G12C • BRAF V600 • EGFR L858R • EGFR T790M • KRAS G12D • ALK rearrangement • MET exon 14 mutation • EGFR L861Q • ROS1 fusion • EGFR G719X • MET mutation • EGFR S768I • RET rearrangement • KRAS G12 • KRAS G12S • KRAS Q61
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D3S-002 • elisrasib (D3S-001)
3d
Successful simplified genomic profiling of cytology specimens using Aspyre Clinical Test for Lung (Tissue). (PubMed, Cancer Cytopathol)
Aspyre Clinical Test for Lung performs effectively on samples derived from fine needle aspirate rinses and pleural fluid. Using these cytology-based specimens for biomarker testing enables pathologists to perform simplified genomic profiling while preserving valuable tissue specimens, potentially reducing the need for additional invasive procedures.
Journal
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EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • MET (MET proto-oncogene, receptor tyrosine kinase)
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EGFR exon 20 insertion • MET exon 14 mutation • EGFR exon 20 mutation
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Aspyre® Lung • Oncomine Precision Assay
6d
Pitfalls in detecting MET exon 14 skipping variants by DNA- and RNA- based next generation sequencing technologies in a large real-world cohort and results of the first multinational EQA schemes. (PubMed, J Mol Diagn)
They showed high success rates (98%) for FFPE tissue, whereas liquid biopsy tests had lower rates (37.5% in 2022, 63% in 2024), primarily due to low allelic fractions and intronic deletions. This study highlights the importance of analyzing both DNA and RNA, urging improvements in sensitivity, coverage and bioinformatics.
Journal • Real-world evidence • Next-generation sequencing
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MET (MET proto-oncogene, receptor tyrosine kinase)
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MET exon 14 mutation • MET mutation
8d
Dietary and Lifestyle Patterns Among Young Patients with Lung Cancer: Analysis of Mutation-Specific Phenotypes. (PubMed, Cancer Epidemiol Biomarkers Prev)
These findings highlight non-tobacco environmental exposures in young lung cancer and support further investigation of dietary patterns and hormonal factors in mutation-specific disease pathways.
Journal
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HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
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TP53 mutation • KRAS mutation • BRAF mutation • ALK positive • MET exon 14 mutation • ALK fusion • MET mutation
9d
New P1 trial
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HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
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BRAF V600E • KRAS mutation • EGFR mutation • BRAF V600 • HER-2 mutation • EGFR T790M • MET exon 14 mutation • ALK fusion • ROS1 fusion • RET rearrangement
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Tepmetko (tepotinib) • Idafang (ivonescimab)
13d
Rapid On-Site Next-Generation Sequencing: An Alternative to Single-Gene and Send-Out Testing in Non-Small Cell Lung Cancer and Colorectal Cancer in a Community Pathology Laboratory Setting. (PubMed, J Mol Diagn)
In CRC, TAT was 4.1, 5.3, and 10.2; QNS 0%, 0%, 7.5%; detection 63.9%, 62.5%, and 57.1%. OPA provides faster TAT and lower QNS rates with comparable detection of actionable alterations, supporting its use for community-based molecular testing in NSCLC and CRC.
Journal • Next-generation sequencing
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EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2)
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KRAS mutation • KRAS G12C • BRAF mutation • HER-2 amplification • HER-2 mutation • RET fusion • MET exon 14 mutation • ALK fusion • ALK mutation • ROS1 fusion • KRAS G12
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Oncomine Precision Assay
14d
Clinical response in advanced non-small cell lung cancer with high PD-L1 expression and MET exon 14 skipping mutation: a case analysis of overcoming immunotherapy resistance and literature review. (PubMed, Front Oncol)
Following discontinuation of Savolitinib due to drug-induced liver injury, Tislelizumab, previously associated with resistance, was reintroduced as a "rechallenge" successfully re-establishing disease control. Coupled with a systematic review of pertinent literature, this article explores the clinical features, therapeutic challenges, potential resistance mechanisms, and management approaches for such patients. It also outlines future research avenues for combination or sequential therapies, aiming to furnish a more holistic reference for clinical decision-making.
Review • Journal • PD(L)-1 Biomarker • IO biomarker
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PD-L1 (Programmed death ligand 1) • MET (MET proto-oncogene, receptor tyrosine kinase)
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PD-L1 expression • PD-L1 overexpression • MET exon 14 mutation • MET expression
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Tevimbra (tislelizumab-jsgr) • Orpathys (savolitinib)
14d
BC3195 in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
P1/2, N=111, Recruiting, Biocity Biopharmaceutics Co., Ltd. | Not yet recruiting --> Recruiting
Enrollment open • IO biomarker
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EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • NTRK (Neurotrophic receptor tyrosine kinase)
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MET exon 14 mutation
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Keytruda (pembrolizumab)
15d
Crizotinib or vebreltinib response and resistance in advanced non-small cell lung cancer with MET exon 14 skipping. (PubMed, Discov Oncol)
While vebreltinib appears clinically advantageous over crizotinib for METex14-mutated NSCLC, the therapeutic benefits did not reach statistical significance in this study. The observed differential response patterns and resistance mechanisms suggest distinct biological behaviors to type Ia and Ib MET TKIs that warrant further investigation. These findings underscore the need for larger prospective studies to validate the potential superiority of vebreltinib and to better characterize the molecular determinants in NSCLC.
Journal • PD(L)-1 Biomarker • IO biomarker
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EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
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PD-L1 expression • EGFR mutation • PD-L1 overexpression • EGFR amplification • MET exon 14 mutation • MET mutation
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Xalkori (crizotinib) • AiRuiKa (camrelizumab) • Endostar (recombinant human endostatin) • vebreltinib (APL-101)
17d
Comprehensive characterization of non-small cell lung cancer of different PD-L1 expression classes: a study of 1,038 Chinese patients. (PubMed, J Thorac Dis)
This study enriches the current volume of evidence on histopathologic, genetic, immunologic correlates of PD-L1 expression and, to our knowledge, is the first comprehensive analysis of arm-level alterations. Further studies are warranted to validate these finding and to determine their associations with clinical outcomes.
Journal • PD(L)-1 Biomarker • IO biomarker
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EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CD8 (cluster of differentiation 8)
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PD-L1 expression • BRAF V600E • KRAS mutation • PD-L1 overexpression • BRAF V600 • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • MET exon 14 mutation • ALK fusion • ALK mutation • ROS1 fusion • MET mutation • KRAS G12 • EGFR positive • HER-2 exon 20 mutation
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PD-L1 IHC 22C3 pharmDx
17d
The landscape of MET alterations in non-small cell lung cancer in Southeastern China: a real-world study. (PubMed, BMC Cancer)
MET alterations occur predominantly in the elderly, males, and smokers. MET-Ex14 shows driver-dependent characteristics with clear MET-TKI benefit. MET-Amp presents the most aggressive phenotype. MET IHC-Pos predominates (> 80%) with heterogeneity; the 2 + /3 + may benefit from MET-TKI. These findings inform subtype-based management of MET-altered NSCLC in southeastern China.
Journal • Real-world evidence • IO biomarker
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TP53 (Tumor protein P53) • MET (MET proto-oncogene, receptor tyrosine kinase)
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MET amplification • MET exon 14 mutation • MET mutation
19d
Comprehensive characterization of MET exon 14 skipping mutations in non-small cell lung cancer. (PubMed, Respir Res)
This study provides a comprehensive characterization of METΔex14 in NSCLC, revealing its dual role as a primary driver of oncogenesis and a potential resistance mechanism to EGFR/ALK inhibitors. The identification of concurrent genetic alterations and potential resistance mechanisms enhances our molecular understanding of treatment responses. These findings highlight the need for further investigation into targeted therapies that consider the genomic complexity of METΔex14 to improve treatment efficacy and patient outcomes.
Journal
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TP53 (Tumor protein P53) • MET (MET proto-oncogene, receptor tyrosine kinase) • FGFR3 (Fibroblast growth factor receptor 3) • TACC3 (Transforming acidic coiled-coil containing protein 3) • CDK4 (Cyclin-dependent kinase 4)
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KRAS mutation • MET amplification • MET exon 14 mutation
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GeneseeqPrime™ • GeneseeqPrime™HRD
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Xalkori (crizotinib) • Orpathys (savolitinib)