FDA approves first engineered T-cell therapy for solid tumor.

The U.S. Food and Drug Administration (FDA) has approved Tecelra (afamitresgene autoleucel) to treat adults with unresectable or metastatic synovial sarcoma. Tecelra is an engineered T-cell receptor (TCR) therapy, a type of cancer cell and gene therapy. It requires the engineering of a patient’s own T cells to attack cancer more effectively.

Tecelra is the first TCR therapy approved for cancer and the first engineered T-cell therapy approved to treat a solid tumor. The approval requires people with synovial sarcoma to have received prior chemotherapy, be positive with at least one of HLA antigens A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P, and have a tumor expressing the MAGE-A4 antigen.

Tecelra, manufactured by Adaptimmune, is administered intravenously as a single dose.

What is synovial sarcoma?

Synovial sarcoma is a rare form of soft-tissue cancer diagnosed in approximately 1,000 people in the United States each year. The cancer commonly develops in the extremities and most often occurs in adult males younger than age 40. 

According to the National Institutes of Health, the 5-year survival rate for adults with synovial sarcoma is 50-60%. Treatment typically involves surgery, chemotherapy and radiation therapy. Tecelra’s approval provides another option for patients who cannot have surgery. 

How does Tecelra fight cancer?

TCR therapies involve genetically modifying T cells to help them target a specific antigen expressed by cancer cells. T cells are engineered to express a receptor that looks for this specific antigen. Tecelra targets the antigen MAGE-A4, which is expressed by synovial sarcoma cells. 

The FDA approval of Tecelra follows a phase 2 clinical trial including 44 people with synovial sarcoma. The overall anti-tumor response rate to the TCR therapy was 43%, and 17% of study participants had a response lasting at least 12 months. An anti-tumor response is defined as a decrease in tumor size (either partially or a complete disappearance).