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    BIOMARKER:

    ROS1 rearrangement

    i
    Other names: ROS1, ROS Proto-Oncogene 1 Receptor Tyrosine Kinase, V-Ros Avian UR2 Sarcoma Virus Oncogene Homolog 1, C-Ros Oncogene 1 Receptor Tyrosine Kinase, Proto-Oncogene Tyrosine-Protein Kinase ROS, Proto-Oncogene C-Ros-1, MCF3, ROS, V-Ros UR2 Sarcoma Virus Oncogene Homolog 1 (Avian), ROS Proto-Oncogene 1 Receptor Tyrosine Kinase, Transmembrane Tyrosine-Specific Protein Kinase, Receptor Tyrosine Kinase C-Ros Oncogene 1, C-Ros Receptor Tyrosine Kinase, Proto-oncogene C-Ros, C-Ros-1
    Entrez ID:
    6098
    Related biomarkers:
    Expression
    Mutation
    CNA
    Fusion
    Others
    2d
    Novel Pattern of Nuclear Staining With ROS1 Immunohistochemistry: A Case Report. (PubMed, Case Rep Pulmonol)
    Immunostaining for ALK was negative, and there was no expression of PD-L1 22C3 IHC. This case report highlights an unexpected ROS1 IHC staining associated with a rare ROS1 gene rearrangement.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    PD-L1 expression • ROS1 rearrangement
    |
    PD-L1 IHC 22C3 pharmDx
    7d
    ALINEAR: Trop2 NMR Concordance Study (clinicaltrials.gov)
    P=N/A, N=3400, Not yet recruiting, AstraZeneca
    New trial
    |
    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)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • ALK rearrangement • EGFR L861Q • ROS1 rearrangement • EGFR G719X • EGFR S768I
    |
    VENTANA® TROP2 (EPR20043) RxDx Assay
    11d
    Exploratory plasma ctDNA genomic biomarkers identified by whole-exome sequencing and a novel bioinformatics pipeline in advanced driver-negative NSCLC. (PubMed, Sci Rep)
    In the Cox model, CYP4F2 (HR = 2,846; IC 95%: 1,102-7,352; p = 0,031) and TPSB2 (HR = 3,089; IC95%: 1,053-9,060; p = 0,040) were independently biomarkers associated with shorter OS (χ² =13,128; p = 0.004), and CYP4F2 (HR = 3,167; IC95%: 1,384-7,244; p = 0,006) remained an independent predictor of shorter PFS (χ² =11.116; p = 0.011). This proof-of-concept study demonstrates that WES of ctDNA processed through the AIRGenomics platform is viable in real-world cases of advanced NSCLC treated with immunotherapy, detecting new potential candidate genes and pathways like predictive biomarkers, such as CYP4F2, ARSD, and TPSB2.
    Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker • Circulating tumor DNA
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • KMT2C (Lysine Methyltransferase 2C)
    |
    ALK rearrangement • ROS1 rearrangement
    14d
    STARTRK-2: Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) (clinicaltrials.gov)
    P2, N=534, Active, not recruiting, Hoffmann-La Roche | Trial completion date: May 2026 --> Jun 2027 | Trial primary completion date: May 2026 --> Jun 2027
    Trial completion date • Trial primary completion date • Pan tumor
    |
    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)
    |
    ALK rearrangement • ROS1 rearrangement
    |
    Xalkori (crizotinib) • Rozlytrek (entrectinib)
    19d
    LUN 17-139: Phase II Randomized Trial of Carboplatin+Pemetrexed+Bevacizumab+/- Atezolizumab in Stage IV NSCLC (clinicaltrials.gov)
    P2, N=107, Active, not recruiting, Fox Chase Cancer Center | Trial primary completion date: Jan 2026 --> Dec 2026 | Recruiting --> Active, not recruiting
    Enrollment closed • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    EGFR mutation • ALK rearrangement • ROS1 rearrangement
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • carboplatin • pemetrexed
    19d
    Association of PD-L1 expression and clinical outcomes in ROS1-rearranged advanced non-small cell lung cancer treated with entrectinib. (PubMed, Transl Lung Cancer Res)
    No statistically significant difference was observed (P=0.65). This study did not find evidence that baseline PD-L1 expression significantly influences the efficacy of entrectinib in advanced ROS1-rearranged NSCLC patients.
    Clinical data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    PD-L1 expression • PD-L1 negative • ROS1 positive • ROS1 rearrangement
    |
    Rozlytrek (entrectinib)
    19d
    Timing of definitive pleural intervention within systemic anticancer therapy in malignant pleural effusion from high-response lung cancers: a retrospective single-center cohort study. (PubMed, Transl Lung Cancer Res)
    Nevertheless, the results suggest that the timing of definitive pleural intervention may play an important role in prognostic outcomes. Prospective studies are warranted to provide more conclusive answers to this important question.
    Retrospective data • Journal • Pleural effusion
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    ALK rearrangement • ROS1 rearrangement
    1m
    Allogeneic NK Cell Therapy Combined With Standard Maintenance Treatment in Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=20, Not yet recruiting, BOE Technology Group Co., Ltd.
    New P1/2 trial
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    BRAF V600E • KRAS mutation • BRAF V600 • ALK rearrangement • ROS1 rearrangement
    |
    Avastin (bevacizumab) • Erbitux (cetuximab) • capecitabine • pemetrexed
    2ms
    Vebreltinib Plus Chemotherapy as First-line Treatment for MET-overexpressing NSCLC (clinicaltrials.gov)
    P2, N=19, Not yet recruiting, Shanghai Chest Hospital
    New P2 trial
    |
    KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    KRAS G12C • MET amplification • ALK rearrangement • MET exon 14 mutation • MET overexpression • ROS1 rearrangement • MET mutation • KRAS G12 • ALK negative
    |
    vebreltinib (APL-101)
    2ms
    TRUST-III: A Phase III Study Comparing Taletrectinib With Standard Therapy in ROS1 Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients (clinicaltrials.gov)
    P3, N=194, Recruiting, Nuvation Bio Inc. | N=138 --> 194
    Enrollment change
    |
    ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    ROS1 positive • ROS1 rearrangement
    |
    Xalkori (crizotinib) • Ibtrozi (taletrectinib)
    2ms
    Molecular Profiling across 80,000 Patients with Lung Cancer. (PubMed, J Thorac Oncol)
    This is the largest NSCLC dataset analyzed for biomarker distribution across histologies, age, sex and genetic ancestry. This dataset confirms sufficient enough biomarker prevalence across many histological subtypes of NSCLC, providing reassurance that all NSCLC cases should be considered for biomarker workup.
    Journal • Tumor mutational burden
    |
    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) • TMB (Tumor Mutational Burden) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    KRAS G12C • HER-2 amplification • MET amplification • ALK rearrangement • TMB-L • ROS1 rearrangement • RET rearrangement • KRAS G12
    |
    FoundationOne® CDx
    3ms
    Case Report: Pregnant ROS1+ lung cancer patient treated with crizotinib - Impact on infancy. (PubMed, Front Oncol)
    Our report underscores the critical need for rigorous thromboembolic monitoring in pregnant patients undergoing cancer treatment. Furthermore, we provide evidence that placental tissue significantly reduces fetal crizotinib exposure, suggesting that crizotinib might be a viable therapeutic option for maintaining a pregnancy during lung cancer treatment.
    Journal
    |
    ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    ROS1 rearrangement
    |
    Xalkori (crizotinib)