The US Food and Drug Administration (FDA) has granted full approval to Tecelra (afamitresgene autoleucel; afami-cel) and expanded its indication to include patients ages 12 years and older with unresectable or metastatic synovial sarcoma whose disease has progressed after chemotherapy. Eligible patients must be positive for HLA-A*02:01, -A*02:02, -A*02:03, or -A*02:06 and have tumors that express the MAGE-A4 antigen.
Synovial sarcoma is a rare and aggressive soft tissue sarcoma. As the tumor grows larger, affected people may notice a lump or swelling. In some cases, the tumor can limit range of motion or cause numbness and pain if it presses on nearby nerves. Although synovial sarcoma does not have a clearly defined cause, genetic factors are believed to influence the development of this disease. Cells in these tumors are usually characterized by the presence of a translocation involving chromosomes X and 18.
Afami-cel is a melanoma-associated antigen A4-directed genetically modified autologous T cell immunotherapy first approved in 2024. It is indicated in adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy and are HLA-A*02:01, -A*02:02, -A*02:03, or -A*02:06 positive and have tumors that express the MAGE-A4 antigen.
The full approval is based on results from cohorts 1 through 3 in the phase 2, open-label, single-group SPEARHEAD-1 clinical trial (NCT04044768).
The study included a total of 137 patients. Overall response rate (ORR) in patients treated with afami-cel was 43.8% with a complete response rate of 3.6%. The median duration of response was 5.3 months. Among patients who responded to treatment, 31.9% had a duration of response of at least 24 months.
Afami-cel includes a boxed warning for serious or fatal cytokine release syndrome (CRS). The most common adverse events, occurring in at least 20% of patients, were CRS, nausea, vomiting, fatigue, infections, pyrexia, constipation, dyspnea, abdominal pain, noncardiac chest pain, decreased appetite, tachycardia, back pain, hypotension, diarrhea, and edema.
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To learn more about synovial sarcoma and other rare cancers, visit https://checkrare.com/diseases/cancers/
