FDA Approves Adaptimmune's T-cell Therapy Tecelra for Rare Soft Tissue Sarcoma

The FDA has granted accelerated approval to Adaptimmune Therapeutics’ engineered cell therapy Tecelra (afamitresgene autoleucel) for the treatment of certain adults with unresectable or metastatic synovial sarcoma who have already undergone chemotherapy. This approval is significant as it marks the first engineered cell therapy to be authorized for a solid tumor indication in the United States. Additionally, it is the first new therapeutic option for synovial sarcoma in more than a decade. 

Adaptimmune CEO Adrian Rawcliffe hailed the approval as a "culmination of a decade of groundbreaking R&D," suggesting that Tecelra could "redefine the way cancer is treated." Tecelra is specifically indicated for patients who possess HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P alleles and whose tumors express the MAGE-A4 antigen.

The FDA's decision was underpinned by data from the Phase II SPEARHEAD-1 trial, which included 44 patients with HLA-A*02-positive status in the primary investigational group. The primary efficacy measure was the overall response rate, which stood at 43% among those treated with Tecelra. Notably, 4.5% of patients achieved a complete response. The median duration of response (DOR) was six months, with 39% of responders experiencing a DOR of 12 months or longer. However, it is important to note that Tecelra's label includes a boxed warning about the risk of severe or potentially life-threatening cytokine release syndrome.

In anticipation of the potential approval, Adaptimmune secured up to $125 million in financing from Hercules Capital. According to the company, part of these funds will be used to commercialize Tecelra, while another portion will support the launch of their second sarcoma treatment, letetresgene autoleucel, which is expected around 2026. This funding has provided crucial support to Adaptimmune, especially after Roche's Genentech unit terminated a previous $3-billion agreement to develop T-cell therapies for cancer earlier in the year.

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