Cell therapies, originally developed for treating blood cancers, have marked a significant advancement in cancer treatment. Adaptimmune Therapeutics has notably contributed to this field with the recent FDA approval of its product for synovial sarcoma, a rare cancer that affects soft tissues like muscles and ligaments, primarily in males under 30. This approval of Tecelra (afamitresgene autoleucel, or afami-cel), signifies the first engineered cell therapy to be sanctioned for a solid tumor, providing new hope where traditional treatments like surgery and chemotherapy may fall short.
Tecelra functions by modifying a patient’s T cells to target the MAGE-A4 antigen, commonly overexpressed in several solid tumors, including synovial sarcoma. Unlike CAR T-therapies that alter cells to target surface tumor markers, Tecelra uses T cell receptors (TCRs) capable of recognizing internal targets, making them more effective against solid tumors. The FDA’s decision is based on results from a Phase 2 trial with 44 advanced synovial sarcoma patients where Tecelra showed a 43% overall response rate and a median response duration of six months. Notably, nearly 39% of these responses lasted 12 months or more.
However, the treatment comes with its risks, including cytokine release syndrome and neurotoxicity, which are common complications in cell therapies and are highlighted in the therapy’s black box warning. Adaptimmune manufactures Tecelra internally, with plans to use its Philadelphia site for commercial production. Treatment eligibility depends on testing positive for MAGE-A4, determined by an FDA-approved diagnostic from Agilent Technologies.
Though Tecelra is adapted from cell therapy technologies, it isn’t the first FDA-approved cell treatment for solid tumors. Earlier, Iovance’s Amtagvi, made from tumor-infiltrating lymphocytes, acquired approval. Unlike TCR and CAR T therapies that require engineering T cells, Amtagvi uses a patient’s own lymphocytes that naturally recognize the tumor. Nevertheless, Tecelra’s pricing surpasses Amtagvi, reflecting its perceived clinical value in treating a rare cancer type with limited options, priced at $727,000—positioned as the most expensive among its peers.
The approval is an accelerated one, reliant on Phase 2 data, with a continuing confirmatory study. Adaptimmune is also investigating expanding Tecelra’s application to pediatric patients, aiming for peak annual sales close to $400 million. Further, Adaptimmune is exploring additional cell therapies, like lete-cel for synovial sarcoma and myxoid round cell liposarcoma, another rare cancer type. Initially, this program was in partnership with GSK, but following a termination, all rights reverted to Adaptimmune.
Moreover, Adaptimmune has expanded its portfolio through strategic alliances, notably with Roche, and a new partnership initiated in May with Galapagos. This collaboration focuses on developing another MAGE-A4-targeting therapy called uza-cel, primarily for ovarian cancer, with plans for head and neck cancers and other solid tumors. Galapagos’s agreement includes significant financial commitments, alongside R&D funding, solidifying the financial footing for Adaptimmune. As of the end of the first quarter, Adaptimmune reported a sufficient cash reserve estimated to sustain its operations into late 2025, bolstering its pathway forward in advancing cell therapies for various cancers.
This approval of Tecelra not only represents a pivotal step in treating solid tumors through engineered cell therapies but also exemplifies the evolution of treatment options beyond traditional methods, pointing towards a more targeted and potentially effective approach in oncology.
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