TECELRA® (afamitresgene autoleucel) is a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.
This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Synovial sarcoma is a rare and aggressive type of soft tissue sarcoma that often develops near large joints in the arms, legs, or neck, but can also occur in other areas of the body. It primarily affects young adults and adolescents and is characterized by a slow-growing, yet potentially invasive tumor that can spread to other areas, particularly the lungs. Synovial sarcoma typically requires a combination of treatments, including surgery to remove the tumor, radiation therapy to manage any remaining cancer cells, and chemotherapy in certain cases to prevent recurrence or manage advanced disease.
Despite its rarity, synovial sarcoma is a serious condition that can be challenging to treat, especially when diagnosed in later stages. Early detection and treatment are critical for improving outcomes. Advances in treatment strategies, including multimodal approaches and ongoing research into targeted therapies, offer hope for better long-term survival rates and improved quality of life for patients with synovial sarcoma.
Companion diagnostics are essential for determining eligibility for Tecelra in the treatment of synovial sarcoma, as both MAGE-A4 antigen expression and the presence of specific HLA alleles are required. Patients must have tumors that express the MAGE-A4 antigen and be positive for one of the following HLA alleles: HLA-A*02:01P, HLA-A*02:02P, HLA-A*02:03P, or HLA-A*02:06P. These companion diagnostics ensure that Tecelra is administered to patients who meet both criteria, enhancing the likelihood of an effective therapeutic response by ensuring that the immune system and tumor characteristics align with Tecelra’s mechanism of action. This targeted approach increases the precision and efficacy of the treatment.
This companion diagnostic was developed by an IVD manufacturer as a kit. This is a valid FDA approved test if utilized by 3rd party diagnostic labs who have validated the test using the kit on the specified platform. It is not directly orderable from the manufacturer.
This companion diagnostic was developed by an IVD manufacturer as a kit. This is a valid FDA approved test if utilized by 3rd party diagnostic labs who have validated the test using the kit on the specified platform. It is not directly orderable from the manufacturer.
Tecelra is a cancer therapy designed to treat synovial sarcoma by targeting tumors that express the MAGE-A4 protein. It works by helping the immune system recognize and destroy cancer cells that overexpress this specific protein, leading to a more targeted and effective treatment.
Tecelra targets and binds to MAGE-A4-expressing cancer cells, activating the body’s immune system to attack and destroy the tumor. This personalized approach helps improve treatment outcomes for patients with synovial sarcoma who meet the necessary biomarker criteria.
Patients with synovial sarcoma may be eligible for Tecelra if their tumor cells express the MAGE-A4 protein and they carry specific HLA alleles. Testing for both biomarkers is required to confirm eligibility for the therapy.
To determine if a patient is eligible for Tecelra treatment, two companion diagnostic tests are needed: one to confirm overexpression of the MAGE-A4 protein in the tumor, and another to verify the presence of specific HLA alleles.
Testing for MAGE-A4 protein overexpression is typically done using an immunohistochemistry (IHC) test on a sample of the tumor tissue. This test helps identify if the protein is present in sufficient levels to qualify for Tecelra treatment.
Common side effects of Tecelra may include fatigue, nausea, and reactions related to immune system activity, such as inflammation. More serious side effects can occur, and it’s important to discuss these with your healthcare provider before starting treatment.
Adaptimmune is a fully integrated cell therapy company working to redefine how cancer is treated. With its unique engineered T cell receptor (TCR) platform, the Company is developing personalized medicines designed to target and destroy difficult-to-treat solid tumor cancers and improve the patient’s cancer treatment experience.