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    Association details:
    Biomarker:EGFR amplification
    Cancer:Glioblastoma
    Drug:depatuxizumab mafodotin (ABT-414) (Microtubule inhibitor, EGFR-targeted antibody-drug conjugate)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Adult Study: ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma Pediatric Study: Evaluation of ABT-414 in Children With High Grade Gliomas

    Excerpt:
    ...- Availability of adequate biological material (formalin-fixed paraffin embedded [FFPE] tumor) for central testing of Epithelial Growth Factor Receptor (EGFR) amplification...
    Trial ID:
    RTOG Foundation 3508
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma

    Excerpt:
    ...- Participants must have confirmed EGFR amplification by central lab in Phase 2 portion...
    Trial ID:
    NCT02590263
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Expanded Access to ABT-414

    Excerpt:
    ...- Participant must have epidermal growth factor receptor (EGFR) amplification or EGFRvIII mutation....
    Trial ID:
    NCT03123952
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme

    Excerpt:
    ...Subjects must have confirmed EGFR amplification by central lab...
    Trial ID:
    NCT01800695
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification

    Excerpt:
    ...- Must have a confirmed epidermal growth factor receptor amplification in tumor tissue....
    Trial ID:
    Intellance1
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    UNITE Study: Understanding New Interventions With GBM ThErapy

    Excerpt:
    ...- Tumors must demonstrate epidermal growth factor receptor (EGFR) amplification...
    Trial ID:
    UNITE
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Biomedicines
    Title:

    Irinotecan Induces Disease Remission in Xenograft Mouse Models of Pediatric MLL-Rearranged Acute Lymphoblastic Leukemia

    Published date:
    06/23/2021
    Excerpt:
    ...histologically confirmed diagnosis of glioblastoma, EGFR-amplified...patients received Depatux-M 1.25 mg/kg every 2 weeks combined with temozolomide….The median OS was 8.04 months (95% CI, 5.3-10.7), the 12 month-OS was 37%.
    Secondary therapy:
    temozolomide
    DOI:
    10.3390/biomedicines9070711
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ESMO 2020
    Title:

    369MO - Final results of depatuxizumab mafodotin plus temozolomide in recurrent glioblastoma patients: Real-world experience from a multicenter study of Italian Association of Neuro-Oncology (AINO)

    Published date:
    09/18/2020
    Excerpt:
    We report the first “real world” experience of DepatuxM + TMZ in recurrent GBM. We showed encouraging clinical benefit, despite most patients were treated beyond the second-line of therapy. Overall, the results are closed to those reported in previous phase II trial. Toxicity was moderate and manageable. This combination would be re-considered as a potential treatment for this setting of patients.
    Secondary therapy:
    temozolomide
    Evidence Level:
    Sensitive: D – Preclinical
    Source:
    Neurooncol Adv
    Title:

    Tumor volumes as a predictor of response to the anti-EGFR antibody drug conjugate depatuxizumab mafadotin

    Published date:
    08/03/2021
    Excerpt:
    The impact of tumor size on ADC tumor delivery and treatment response was evaluated in an EGFR-amplified patient-derived glioblastoma (GBM) model following treatment with Depatuxizumab mafadotin (Depatux-M)....concordantly, mice with tumor volumes ≤100 mm3 at treatment commencement had significantly better growth inhibition by Depatux-M (93% vs 27%, P < .001) and significantly longer overall survival (P < .0001) compared to tumors ≥400 mm3.
    DOI:
    10.1093/noajnl/vdab102