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    BIOMARKER:

    ALK fusion

    i
    Other names: NBLST3, CD246, Anaplastic Lymphoma Kinase, Anaplastic Lymphoma Kinase (Ki-1), CD246 Antigen, Mutant Anaplastic Lymphoma Kinase, ALK, ALK Receptor Tyrosine Kinase, Anaplastic Lymphoma Receptor Tyrosine Kinase, ALK Tyrosine Kinase Receptor
    Entrez ID:
    238
    Related biomarkers:
    Expression
    Mutation
    CNA
    Fusion
    Others
    Related tests:
    3d
    IM-BATTLE-2 Program: Trametinib and Pembrolizumab in Treating Patients With Recurrent Non-small Cell Lung Cancer That Is Metastatic, Unresectable, or Locally Advanced (clinicaltrials.gov)
    P1/2, N=37, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2027
    Trial completion date • Trial primary completion date
    |
    ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    EGFR T790M • ALK fusion
    |
    Keytruda (pembrolizumab) • Mekinist (trametinib)
    4d
    Pediatric intracranial inflammatory myofibroblastic tumor harboring DCTN1::ALK fusion: a case report with radiologic-pathologic-molecular correlation. (PubMed, Childs Nerv Syst)
    Genomic metrics showed tumor mutational burden (TMB) of 0.94/Mb, microsatellite stability, and CNV burden of 2.1%. He underwent near total resection followed by alectinib; to our knowledge, this is the first reported young pediatric (<10 years old) CNS IMT with this fusion.
    Journal • Tumor mutational burden
    |
    ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • DCTN1 (Dynactin Subunit 1)
    |
    ALK rearrangement • ALK fusion
    |
    Alecensa (alectinib)
    4d
    Preclinical characterization and first-in-human, phase I trial of the novel ALK inhibitor dirozalkib in advanced non-small cell lung cancer. (PubMed, Eur J Cancer)
    Dirozalkib exhibited favorable safety, antitumor activity and pharmacokinetics in patients with advanced ALK-rearranged NSCLC. The recommended phase II dose was 500 mg/day.
    P1 data • Preclinical • Journal • First-in-human
    |
    ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    ALK positive • ALK rearrangement • ALK fusion • ROS1 rearrangement
    |
    Xuan Fei Ning (dirozalkib)
    6d
    Amivantamab With Tyrosine Kinase Inhibitors (TKI) for Advanced NSCLC With ALK, ROS1, or RET Alterations (clinicaltrials.gov)
    P1/2, N=12, Active, not recruiting, University of Colorado, Denver | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    RET fusion • ALK fusion • ROS1 fusion
    |
    VENTANA ALK (D5F3) CDx Assay
    |
    Rybrevant (amivantamab-vmjw)
    7d
    A Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced or Metastatic Cancers (clinicaltrials.gov)
    P1/2, N=73, Terminated, Ocellaris Pharma, Inc. | Trial completion date: Sep 2026 --> Nov 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Mar 2026 --> Nov 2025; Business Decision
    Trial completion date • Trial termination • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • ALK (Anaplastic lymphoma kinase) • PGR (Progesterone receptor) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    HER-2 negative • ALK fusion • ALK mutation • ROS1 fusion
    |
    Bavencio (avelumab) • OC-001
    10d
    Precision oncology promise in the management of pancreatic acinar cell carcinoma. (PubMed, Eur J Cancer)
    In summary, the potential for personalized cancer therapy is promising in PACC. The integration of molecular diagnostics into clinical care is essential for identifying therapeutic targets and optimizing outcomes; continued research and participation in genomically matched clinical trials are key to advancing treatment paradigms for this rare malignancy.
    Review • Journal • BRCA Biomarker • MSi-H Biomarker • PARP Biomarker • IO biomarker
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • TP53 (Tumor protein P53) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability) • HRD (Homologous Recombination Deficiency) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    TP53 mutation • BRAF V600E • MSI-H/dMMR • BRAF V600 • ALK rearrangement • ALK fusion • NTRK fusion
    12d
    SX-682 and Atezolizumab for the Treatment of Advanced or Metastatic, Recurrent Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=32, Not yet recruiting, University of Washington
    New P2 trial • Checkpoint inhibition
    |
    ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CXCL8 (Chemokine (C-X-C motif) ligand 8)
    |
    RET fusion • ALK fusion • ROS1 fusion
    |
    SX-682 • Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    13d
    A Case of Lung Adenocarcinoma With Concurrent EGFR Mutation and ALK Fusion Combined With Literature Review. (PubMed, Clin Case Rep)
    This case underscores the critical importance of retesting for resistant mechanisms, such as EML4-ALK fusion, in patients with EGFR-mutant lung adenocarcinoma who experience rapid progression on EGFR-tyrosine kinase inhibitor (TKI) therapy. Early identification of such co-alterations and an immediate switch to alectinib can lead to rapid and sustained clinical improvement.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • EML4 (EMAP Like 4)
    |
    EGFR mutation • ALK fusion
    |
    Alecensa (alectinib)
    14d
    Malignant melanoma with anaplastic lymphoma kinase positivity: a clinicopathological analysis of three cases (PubMed, Zhonghua Bing Li Xue Za Zhi)
    Aberrant ALK activation suggests its potential role in molecular pathogenesis of malignant melanoma. Further investigation of ALK as a therapeutic target seems necessary.
    Journal
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    KRAS mutation • BRAF mutation • NRAS mutation • PIK3CA mutation • ALK positive • ALK rearrangement • ALK fusion • ALK mutation
    15d
    CTONG 2508: Adaptive Adjuvant Sintilimab Therapy Guided by MRD (ADAPT Lung) (clinicaltrials.gov)
    P2, N=115, Recruiting, Guangdong Association of Clinical Trials | Not yet recruiting --> Recruiting
    Enrollment open
    |
    ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    RET fusion • ALK fusion • ROS1 fusion
    |
    Tyvyt (sintilimab)
    15d
    Ivonescimab combined with chemotherapy shows promising efficacy in an ALK fusion-positive lung adenocarcinoma patient with ALK-TKI resistance: a case report. (PubMed, Front Oncol)
    The patient was initially treated with alectinib, but experienced rapid disease progression. After repeat genetic testing, therapy was switched to lorlatinib, which again resulted in early progression...To our knowledge, this is the first reported case of ivonescimab use in such a patient. This case offers a potential reference for the management of ALK fusion-positive lung adenocarcinoma resistant to ALK tyrosine kinase inhibitors (ALK-TKIs).
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • BCL2 (B-cell CLL/lymphoma 2) • EML4 (EMAP Like 4) • BCL2L11 (BCL2 Like 11) • BAK1 (BCL2 Antagonist/Killer 1)
    |
    PD-L1 expression • ALK positive • ALK fusion
    |
    Alecensa (alectinib) • Lorbrena (lorlatinib) • Yidafan (ivonescimab)
    16d
    Real-world adoption of off-label combinations for targeted therapy resistance in non-small cell lung cancer. (PubMed, Clin Transl Oncol)
    Off-label combination therapy to treat targeted therapy resistance in advanced NSCLC is feasible in routine clinical practice. Additional real-world evidence is needed to clarify best practices with this emerging approach.
    Journal • Real-world evidence
    |
    EML4 (EMAP Like 4)
    |
    EGFR exon 19 deletion • ALK fusion
    |
    gefitinib • Alecensa (alectinib) • Retevmo (selpercatinib) • Tabrecta (capmatinib)