On August 2nd, 2024, the FDA granted accelerated approval for afami-cel -- the first gene-engineered T-cell Therapy for advanced synovial sarcoma and the first T-cell therapy ever to get approved for solid tumors.
Developed by Adaptimmune, afami-cel uses the patient's immune system to fight cancer, a mechanism similar to other existing T-cell therapies on the market. In this treatment, the patient's T cells are genetically modified to recognize and attack sarcoma cells that express MAGE-A4 -- a protein known to promote cancerous growth by inhibiting apoptosis and dodging cell cycle arrest. This offers a personalized and targeted approach to combat advanced synovial sarcoma. The approval of this drug is a groundbreaking step for using T-cell therapy in solid tumors while at the same time addressing an extremely unmet need for patients with limited treatment options.
Clinical Results:
Positive results from the clinical trial (SPEARHEAD-1) showed an overall response rate of 37% in synovial sarcoma and 25% in myxoid round-cell liposarcoma patients. Moreover, the response to treatment was sustained with nearly 40% of patients experiencing response durations beyond 12 months. Compared to existing therapies, the safety of afami-cel is in favor with manageable side effects and limited neutropenia.
This approval positions afami-cel as a leader in TCR T-cell therapies for solid tumors and offers hope for cancer patients and their families.
Learn more about synovial sarcoma, a rare cancer affecting soft tissues through this video.
(Media Source: https://www.youtube.com/watch?v=DxNBeU_V74E)
Created: August 28th, 2024
Citations:
Winstead, E. (2024, August 27). First cancer TCR cell therapy approved by FDA. First Cancer TCR Cell Therapy Approved by FDA - NCI. https://www.cancer.gov/news-events/cancer-currents-blog/2024/fda-tecelra-synovial-sarcoma-mage-a4#:~:text=Afami%2Dcel%20is%20approved%20for,people%20with%20metastatic%20synovial%20sarcoma.
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