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    DRUG:

    bozitinib (APL-101)

    i
    Other names: CBT 101, CBT-101, APL101, APL-101, PLB-1001, CBI-3103, PLB1001
    Company:
    Apollomics, Avistone Biotech, LaunXP Biomedical
    Drug class:
    c-MET inhibitor
    Related drugs:
    29d
    A Concise Review of the Approved MET TKIs (Savolitinib, Gumarontinib, Vebreltinib, Tepotinib, Capmatinib) in China for MET Exon 14 Splice Site Mutated (METex14+) NSCLC Circa 2025. (PubMed, Lung Cancer (Auckl))
    Splice site mutations around or within exon 14 of MET (METex14+) are rare, but are one of the common actionable driver mutations in elderly patients with non-small cell lung cancer (NSCLC). On June 30, 2025, vebreltinib has been approved for NSCLC with MET amplification while combination of savoltinib and osimertinib has been approved for EGFR+ post EGFR TKINSCLC with MET amplification post EGFR TKI based on the SACHI trial (NCT05015608). We discuss the current unmet clinical need (need to develop Type II MET TKI to overcome acquired resistance MET mutations at D1228 and Y1230) and future optimal treatment approaches.
    Review • Journal
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET amplification • MET exon 14 mutation • MET mutation
    |
    Tagrisso (osimertinib) • Orpathys (savolitinib) • Tepmetko (tepotinib) • Tabrecta (capmatinib) • Haiyitan (gumarontinib) • bozitinib (APL-101)
    1m
    A Dose Escalation Study of Vebreltinib Combined with Gamma Knife and Osimertinib in Non-Small Cell Lung Cancer Patients with New Intracranial Metastases or Progression of Original Intracranial Metastatic Lesions Accompanied by MET Abnormalities in Intracranial Lesions During Osimertinib Treatment (ChiCTR2500108242)
    P=N/A, N=9, Not yet recruiting, Beijing Tiantan Hospital Affiliated to Capital Medical University; Beijing Tiantan Hospital Affiliated to Capital Medical University
    New trial
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET amplification • MET exon 14 mutation • MET overexpression • MET mutation
    |
    Tagrisso (osimertinib) • bozitinib (APL-101)
    1m
    A Open-Label, Randomized Controlled, Exploratory Clinical Study of Vebreltinib Combined with Temozolomide and Bevacizumab in Patients with Recurrent/Progressive Malignant Gliomas without MET Abnormalities (ChiCTR2500107448)
    P=N/A, N=64, Not yet recruiting, Beijing Tiantan Hospital, Capital Medical University; Beijing Tiantan Hospital, Capital Medical University
    New trial
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET amplification • MET overexpression • MET mutation
    |
    Avastin (bevacizumab) • temozolomide • bozitinib (APL-101)
    3ms
    Vebreltinib for Neoadjuvant in METex 14 Skipping Mutant Stage IIA-IIIB (N2) Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Fudan University
    New P2 trial
    |
    bozitinib (APL-101)
    3ms
    Vebreltinib for Advanced or Metastatic CCS (clinicaltrials.gov)
    P2, N=30, Recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University
    New P2 trial
    |
    bozitinib (APL-101)
    3ms
    Bozitinib Combined With Chemotherapy as Radical Treatment for Stage IIA-IIIC MET-Altered Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=34, Not yet recruiting, Shanghai Pulmonary Hospital, Shanghai, China
    New P2 trial
    |
    bozitinib (APL-101)
    4ms
    Efficacy and safety of Vebreltinib combined with bevacizumab for metastatic non-squamous non-small cell lung cancer harboring MET exon 14 skipping mutations : A single-arm, single-center, phase Ⅱ study (ChiCTR2500104259)
    P2, N=30, Not yet recruiting, The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Zhengzhou University
    New P2 trial
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET exon 14 mutation
    |
    Avastin (bevacizumab) • bozitinib (APL-101)
    4ms
    Phase Ib/II Study of Vebreltinib With Furmonertinib in NSCLC Patients With c-Met Amplification After EGFR-TKI Failure (clinicaltrials.gov)
    P1/2, N=42, Recruiting, Peking University Cancer Hospital & Institute
    New P1/2 trial
    |
    Ivesa (firmonertinib) • bozitinib (APL-101)
    5ms
    A Study of Vebreltinib and Platinum-Containing Double Agents in Subjects With MET Amplification. (clinicaltrials.gov)
    P3, N=280, Recruiting, Beijing Pearl Biotechnology Limited Liability Company | Not yet recruiting --> Recruiting | Initiation date: Apr 2025 --> Jun 2025
    Enrollment open • Trial initiation date
    |
    cisplatin • carboplatin • bozitinib (APL-101)
    6ms
    Treatment of a newly diagnosed glioblastoma harboring MET amplification with vebreltinib in combination with radiotherapy: a case report. (PubMed, Discov Oncol)
    Our paper describes the use of vebreltinib in a newly diagnosed glioblastoma patient harboring MET amplification. This successful case study suggests that novel targeted MET inhibitors may provide potential clinical benefits in select cases on the basis of the MET signaling pathway status.
    Journal
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET amplification
    |
    bozitinib (APL-101)
    6ms
    Enhancing the Precision and Efficiency of Pulmonary Tumor Detection With Robotic-Assisted 18F-FDG PET/CT-Guided Lung Biopsy: A Case Report. (PubMed, Thorac Cancer)
    Genetic testing identified a MET mutation, leading to targeted therapy with Bozitinib...This case underscores the potential advantages of robotic-assisted 18F-FDG PET/CT-guided lung biopsy in enhancing diagnostic sensitivity and procedural efficiency by precisely targeting metabolically active areas, minimizing needle adjustments, and potentially reducing false-negative results. Broader application in interventional radiology and oncology warrants further investigation.
    Journal
    |
    MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    MET mutation
    |
    bozitinib (APL-101)
    7ms
    Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI (clinicaltrials.gov)
    P1/2, N=156, Recruiting, Avistone Biotechnology Co., Ltd. | Trial completion date: Jun 2025 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    bozitinib (APL-101) • andamertinib (PLB1004)