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Association details:
Evidence:
Evidence Level:
Sensitive: A1 - Approval
Source:
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
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. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

SPEARHEAD-3 Pediatric Study

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

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

Excerpt:
......
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
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:
Evidence Level:
Sensitive: C3 – Early Trials
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.