Tecelra

2024: Product Release

In early August 2024, regulatory authorities approved the use of the first T-cell therapy for the treatment of inoperable or metastatic synovial sarcoma resistant to chemotherapy.

Synovial sarcoma is a rare form of cancer in which malignant cells develop in the soft tissues of the body, most often in the limbs. Most commonly, this type of tumor occurs in young men aged 30 or younger. Treatment usually involves surgery and radiotherapy and/or chemotherapy, however therapy does not help all patients. The registration of a new modern immunotherapy drug may be the last chance for patients who have exhausted other treatment options.

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Tecelra is the first approved gene therapy drug associated with T cell receptor (TCR) modification. During the therapy, the patient is injected with his own T cells, which have been modified so that TCR interacts with the tumor antigen MAGE-A4. The drug is administered as a single intravenous infusion.

The safety and efficacy of the new drug was evaluated in a multicenter, open-label clinical trial involving patients with unresectable and metastatic synovial sarcoma who had previously received systemic therapy. Among the 44 patients who received Tecelra, the overall response rate was 43.2% and the median duration of response was six months. Among the dangerous side effects of the drug, the cytokine release syndrome (CRS) characteristic of immunotherapy, which is an aggressive reaction of the immune system, as well as the neurotoxicity syndrome associated with immune effector cells (ICANS), stands out. Patients receiving this drug should be monitored for symptoms of infection and should not drive or engage in hazardous activities for at least four weeks after administration of the drug.^[1]

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