In August 2024, the US Food and Drug Administration (FDA) approved Adaptimmune Therapeutics’ Tecelra (afami-cel), a T cell receptor (TCR) therapy treating adults with metastatic synovial sarcoma. Tecelra becomes the first US-marketed TCR therapy for solid tumours.
Patients of a specific HLA [human leukocyte antigen] type with tumours that express melanoma-associated antigen A4 and who have previously undergone chemotherapy are eligible for the therapy. The licence is based on the pivotal Phase II SPEARHEAD-1 study in which 43% of patients responded to the treatment and 4.5% achieved a complete response. The median duration of response was six months, yet 39% of patients maintained their response at one year or longer. Median overall survival (OS) for patients who responded was not reached, but the estimated 24-month OS for these patients is 70%. Currently, five-year survival rates for those diagnosed with the rare cancer are as low as 20% and no new options have reached the market in more than a decade.
Cell therapies, specifically CAR-[chimeric antigen receptors]Ts, have revolutionised blood cancer treatment. These genetically engineered T cells are better equipped for recognising cancer-specific antigens on the tumour cell surface with the addition of the CAR. Due to the heterogeneity and lack of specific antigens on the surface of solid tumours, developing these therapies for solid tumours — the vast majority of cancers — has been unsuccessful.
Although similar, TCR therapies are minimally engineered and can target both cell surface antigens and intracellular antigens. In addition to Tecelra, AdaptImmune’s pipeline TCR therapy lete-cel met its primary efficacy endpoint of objective response rate for pretreated synovial sarcoma and myxoid/round cell liposarcoma with a planned biologics licence application submission in 2025. The two cancers make up roughly 10 to 20% of soft-tissue sarcomas. The approval of lete-cel would multiply the US addressable market by 2.5 times, from 400 patients annually with Tecelra to 1,000. The treatments could be combined or administered sequentially, as lete-cel targets another antigen.
GlobalData consensus analysts predict sales of Tecelra to be $13 million in 2025, with gradual growth peaking at $70 million by 2030. These modest projections signify a strikingly low uptake for the therapy, which can be explained by its high list price of $727,000 and its availability only in select authorised treatment centres. These conservative projections should be offset by the unmet need for an overall young adult patient population, an established reimbursement pathway for approved cell therapies, and a market launch ex-US [via an investment fund that specifically excludes shares or other securities issued by American companies].
Outside of sarcoma, the company is developing uza-cel, a TCR currently in a registrational Phase II study for platinum-resistant ovarian cancer. GlobalData projects the overall TCR market for solid tumour cancers to reach $929 million by 2030.
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By GlobalData