Tecelra by Adaptimmune receives fast-track approval for synovial sarcoma

Adaptimmune Therapeutics, an Oxford-based cell therapy company, has achieved accelerated approval from the US Food and Drug Administration (FDA) for its cell therapy Tecelra (afamitresgene autoleucel) for the treatment of synovial sarcoma. Tecelra is notable for being the first engineered cell therapy for solid tumors approved in the United States. It is also the first new therapy option for synovial sarcoma in over ten years.

Tecelra is designed to treat adults with unresectable or metastatic synovial sarcoma who have previously undergone chemotherapy and whose tumors express the melanoma-associated antigen A4 (MAGE-A4). Additionally, patients' tumors must have specific human leukocyte antigen (HLA) types: HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive.

The FDA's approval was based on data from the Phase II SPEARHEAD-1 trial (NCT04044768), which included 44 patients with synovial sarcoma. The trial demonstrated an overall response rate (ORR) of 43%, with a median duration of response of six months. Future approvals will depend on the verification of clinical benefits in ongoing trials.

Synovial sarcoma is a rare and aggressive form of soft tissue cancer with a five-year survival rate of approximately 36%, which drops to 20% for metastatic cases. This type of cancer predominantly affects young adults, with one-third of patients being diagnosed before the age of 30. Brandi Felser, CEO of the Sarcoma Foundation of America, expressed that the FDA's approval of Tecelra brings a renewed sense of hope to the affected patients and their families.

Adaptimmune has been proactive in forming strategic partnerships to advance its therapies. In 2021, the company entered a collaboration with Genentech, a division of Roche, to develop T cell therapies. This five-year agreement could result in Adaptimmune receiving more than $3 billion. Additionally, Adaptimmune partnered with Agilent Technologies to develop the MAGE-A4 ICH 1F9 pharmDx companion diagnostic, which also received FDA approval, and with Thermo Fisher Scientific for the inclusion of Tecelra in the labeling of their SeCore CDx HLA-A Locus Sequencing System.

Financial projections from GlobalData suggest that afamitresgene autoleucel will generate $9 million in revenue for Adaptimmune this year, with expectations to reach $97 million by 2030. Adaptimmune has announced its readiness to take orders for Tecelra and has launched the AdaptimmuneAssist program to support personalized treatments. The company plans to have at least six treatment centers operational this year, expanding to 30 centers within two years.

In a recent press release, Adrian Rawcliffe, CEO of Adaptimmune, mentioned the company's future plans, including the progression of lete-cel, another investigational treatment in their sarcoma franchise. A rolling Biologics License Application (BLA) submission to the FDA for lete-cel is expected next year.

Adaptimmune's innovative approach and successful FDA approval mark significant milestones in the treatment of synovial sarcoma, providing new hope and options for patients suffering from this challenging disease.

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