Tecelra® Receives FDA Approval: A New Milestone in Cancer Treatment

On August 2, 2024, the U.S Food and Drug Administration (FDA) approved Tecelra® (afamitresgene autoleucel), a gene therapy for treating unresectable or metastatic synovial sarcoma in adults who have received prior chemotherapy. The approval marks a significant advancement in the fight against this cancer, as it is also the first new treatment option for patients with synovial sarcoma in over a decade.

Tecelra® was approved using the Accelerated Approval pathway, the avenue the FDA uses to approve drugs for serious or life-threatening diseases where there is an unmet medical need, and the drug is shown to affect a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. For years, treatment options for patients with synovial sarcoma have been limited, with only 36 percent of patients surviving beyond five years after diagnosis. Tecelra® is poised to become a powerful tool in the growing arsenal of immunotherapies, specifically for solid tumors like synovial sarcoma.

Tecelra®, a CAR T-based immunotherapy, has shown remarkable efficacy in clinical trials. It targets the MAGE-A4 protein on cancer cells, allowing the immune system to more effectively recognize and destroy them. Tecelra® was tested in the SPEARHEAD-1 trial, a multi-center, open-label study involving 44 patients with inoperable and metastatic synovial sarcoma. These patients had previously received systemic therapy and their tumors expressed the MAGE-A4 antigen. The study reported an impressive overall response rate of 43.2% among patients receiving Tecelra®, leading to its recent approval. As a result, the FDA approved Tecelra® specifically for patients whose cancer cells express the MAGE-A4 protein.

For over seven decades, the Cancer Research Institute (CRI) has supported transformational discoveries to find ways to harness the power of the immune system to combat cancer. Solid tumors, such as sarcoma, are particularly challenging to treat with immunotherapy. Their genetic complexity, driven by multiple mutations and evolutionary mechanisms that help them evade immune surveillance, makes them more resistant to these treatments. The approval of Tecelra® presents a new path for combating hard-to-treat solid tumors with the power of immunotherapy.

CRI Clinical Accelerator Investigator Dimitriy Zamarin, MD, PhD, from Mount Sinai, spoke with CRI about the unique challenge solid tumors provide for researchers.

“Solid tumors are genetically very complex, they take many years to develop and over this course of genetic evolution of cancer, they acquire (all the) mutations,” Dr. Zamarin said. Solid tumors must counter the adverse immune pressure and acquire mechanisms enabling them to avoid the immune system and making immunotherapies ineffective against these cancers. However, he remained hopeful and stated, “While we know one type of immune therapy might not be effective, perhaps a certain combination of therapies may be, and by identifying the mechanisms of immune escape we will be able to target these mechanisms to treat these cancers.”

Watch full interview with Dr. Dimitriy Zamarin here

Today, CRI-funded scientists are involved in many upcoming areas of research, including developing more efficient CAR T therapies for targeting different types of tumors. Additionally, CRI is committed to ensuring that such therapies are accessible to all who need them. Our clinical trials network and partnerships with leading cancer centers worldwide help accelerate the delivery of promising immunotherapy treatments from the lab to the clinic.

As Tecelra® begins to make a difference in patients’ lives, CRI remains dedicated to advancing immunotherapy treatment and accessibility. We believe this is just the beginning, and we are excited to see how a new age of immunotherapies continue to create a world immune to cancer.