FDA fast-tracks Adaptimmune's Tecelra for synovial sarcoma

Adaptimmune Therapeutics has achieved a significant milestone with the US Food and Drug Administration (FDA) granting accelerated approval for its engineered cell therapy, Tecelra (afamitresgene autoleucel), to treat specific cases of synovial sarcoma. This approval marks the first of its kind for engineered cell therapy targeting a solid tumor cancer in the United States. The therapy is intended for adults suffering from unresectable or metastatic synovial sarcoma who have previously undergone chemotherapy.

Eligibility for Tecelra goes beyond just the cancer type; patients must test positive for the HLA-A02:01P, -A02:02P, -A02:03P, or -A02:06P markers and express the MAGE-A4 antigen, as verified by an FDA-approved diagnostic device.

Synovial sarcoma, a rare cancer that typically arises near large joints, accounts for up to 10% of all soft tissue sarcomas, with around 13,400 new cases diagnosed annually in the US. This cancer primarily affects younger adults, many of whom experience recurrence and require multiple treatment lines even after receiving standard care for advanced stages of the disease.

Tecelra represents a revolutionary treatment approach by utilizing the patient's own immune cells to target and destroy cancer cells through a single infusion. This innovative therapy is the first new treatment option for synovial sarcoma introduced in over a decade. The FDA's decision was underpinned by promising outcomes from cohort one of the mid-stage SPEARHEAD-1 trial. In this trial, Tecelra achieved an overall response rate of 43% and a complete response rate of 4.5%. The median duration of response was six months, and for those responding to the treatment, 39% maintained their response for a year or more.

Dr. Sandra D’Angelo of Memorial Sloan Kettering Cancer Center, the principal investigator for the SPEARHEAD trial, highlighted Tecelra’s unique mechanism compared to the existing standards of care for advanced synovial sarcoma. She emphasized that this approval offers a much-needed new treatment option for those diagnosed with this challenging cancer and marks a pivotal advancement for cell therapies in treating solid tumors.

Adaptimmune Therapeutics has ambitious plans to support Tecelra's rollout. The company aims to establish at least six to ten authorized treatment centers by the end of this year and expand to approximately 30 centers within the next two years.

As part of the FDA's accelerated approval program, Tecelra's continued authorization for treating synovial sarcoma will hinge on further validation of its clinical benefits through a confirmatory trial.