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    Association details:
    Biomarker:MAGEA4 expression
    Cancer:Synovial Sarcoma
    Drug:Tecelra (afamitresgene autoleucel) (TCR modulator, MAGE-A4 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    FDA
    Title:

    FDA Approves First Gene Therapy to Treat Adults with Metastatic Synovial Sarcoma

    Published date:
    08/02/2024
    Excerpt:
    The U.S. Food and Drug Administration approved Tecelra (afamitresgene autoleucel), a gene therapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA antigen(s) A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive, and whose tumor expresses the MAGE-A4 antigen as determined by FDA authorized companion diagnostic devices.
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    SPEARHEAD-3 Pediatric Study

    Excerpt:
    ...- Tumor shows MAGE-A4 expression confirmed by central laboratory....
    Trial ID:
    NCT05642455
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

    Excerpt:
    ......
    Trial ID:
    SPEARHEAD-1
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Study to assess the safety and efficacy of T cell therapy in patients with advanced cancer

    Excerpt:
    ...Tumor (either an archival specimen or a fresh biopsy) shows MAGE-A4 expression of ≥2+ staining in ≥30% of the cells by immunohistochemistry. ...
    Trial ID:
    2019-000589-39
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    J Clin Oncol
    Title:

    SPEARHEAD-1: A phase 2 trial of afamitresgene autoleucel (Formerly ADP-A2M4) in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma.

    Published date:
    05/28/2021
    Excerpt:
    Eligible pts are HLA-A*02 positive with MAGE-A4-expressing tumors….32 pts received afamitresgene autoleucel…. Of the 25 evaluable pts, the investigator-assessed responses were: complete response (2 pts), partial response (8 pts), stable disease (11 pts)...All responses were confirmed....preliminary data demonstrate afamitresgene autoleucel is efficacious and well tolerated in heavily pre-treated pts.
    DOI:
    10.1200/JCO.2021.39.15_suppl.11504
    Trial ID:
    SPEARHEAD-1
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Adaptimmune Press Release
    Title:

    Durable Responses with ADP-A2M4 in Synovial Sarcoma with Confirmed Responses in 44% of Patients and Disease Control Rate of 94% Presented at CTOS

    Published date:
    11/19/2020
    Excerpt:
    16 patients with synovial sarcoma who were treated in the Phase 1 ADP-A2M4 trial...Seven out of 16 patients (44%) had confirmed partial responses (PRs) per RECIST criteria, with disease control in 15 patients (94%)...MAGE-A4 expression and transduced cell dose correlate with tumor reduction.