The U.S. Food and Drug Administration (FDA) has granted accelerated approval to afamitresgene autoleucel (TECELRA, Adaptimmune, LLC), a genetically modified autologous T cell immunotherapy. This approval targets adult patients with unresectable or metastatic synovial sarcoma, particularly those who have undergone prior chemotherapy and possess specific HLA-A alleles, with tumors expressing the melanoma-associated antigen A4 (MAGE-A4).
Image Source: Vinoth Khandelwal
Afamitresgene autoleucel is a MAGE-A4-directed T cell receptor (TCR) therapy. It involves the genetic modification of a patient’s own T cells to recognize and attack cancer cells expressing the MAGE-A4 antigen. The therapy is administered as a single infusion, with the recommended dose ranging from 2.68 x 10^9 to 10 x 10^9 MAGE-A4 TCR-positive T cells.
Afamitresgene autoleucel’s approval falls under the FDA’s accelerated approval pathway, highlighting its potential to address a serious condition with unmet medical needs. The therapy was also granted Regenerative Medicine Advanced Therapy, priority review, and orphan drug designation, reflecting its innovative nature and the urgency of its development.
The efficacy of afamitresgene autoleucel was evaluated in the SPEARHEAD-1 trial, a multicenter, single-arm, open-label clinical study. This trial enrolled 52 patients with unresectable or metastatic synovial sarcoma, all of whom had received prior systemic therapy and were positive for specific HLA-A alleles. Of these, 44 patients received the treatment after undergoing lymphodepleting chemotherapy with fludarabine and cyclophosphamide.
The main efficacy outcome was the overall response rate (ORR), which stood at 43.2%, with a median duration of response (DOR) of 6 months. This indicates a promising response in nearly half of the treated patients, with significant durability for some, as 45.6% of responders maintained their response for at least 6 months, and 39.0% for 12 months or more.
The accelerated approval of afamitresgene autoleucel marks a significant advancement in the treatment of unresectable or metastatic synovial sarcoma, providing a new option for patients with limited alternatives. Continued research and postmarketing studies will be essential to confirm its long-term benefits and safety profile.
Dr. Vinoth Khandelwal, Ph.D.
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