When immunotherapy fails and skin cancer continues to spread, standard treatment offers few remaining options. Immatics' TCR-T cell therapy anzu-cel from Tübingen could fundamentally change this picture: in clinical studies, 56 percent of heavily pretreated melanoma patients responded to the therapy, with a median response duration of 14.6 months. First data from the pivotal Phase 3 SUPRAME study are expected in 2026.
How TCR-T Cells Differ from CAR-T Cells
Cancer immunotherapy has undergone a first revolution in the past decade: CAR-T cells, genetically engineered T lymphocytes with an artificial receptor, achieve response rates exceeding 80 percent in certain B-cell leukemias. For solid tumors, CAR-T therapies have remained largely ineffective. Solid tumors account for more than 80 percent of all cancers: lung, colon, breast, skin.
The problem lies in the recognition mechanism. CAR-T cells recognize antigens on the cell surface. Solid tumors present a poor target because they create a hostile microenvironment that exhausts infiltrating immune cells, and most tumor-specific antigens are hidden inside the cell.
TCR-T cells (T-cell receptor T cells) use the natural T-cell receptor instead. Rather than recognizing surface proteins, it recognizes short peptide fragments that cells transport from their interior to the outside and display on a so-called MHC molecule. This opens access to proteins concentrated in tumor cell interiors but barely present in healthy adult body cells.
The target protein PRAME (Preferentially Expressed Antigen in Melanoma) is precisely one such pattern. According to analysis of over 5,800 tissue samples published in The American Journal of Surgical Pathology, 87 percent of all metastatic melanomas express PRAME. In ovarian cancers, the proportion exceeds 80 percent. In healthy adult body cells, PRAME barely appears, making it an attack target without risking broad collateral damage.
What the Data Show
Immatics presented anzu-cel at the American Society of Clinical Oncology (ASCO) annual congress in June 2026 in Chicago with extended data. Diwakar Davar from the University of Pittsburgh Medical Center Hillman Cancer Center presented analysis of 32 evaluable melanoma patients who had already received a median of two prior therapies. The confirmed objective response rate (cORR) was 56 percent, with median response duration of 14.6 months. Median overall survival was 16.2 months.
For context: melanoma patients who have already received PD-1 immunotherapy and did not respond sufficiently have few effective alternatives in standard treatment. That anzu-cel achieves measurable tumor reduction in more than half of this difficult-to-treat population is clinically remarkable. However, Phase 1b studies without a control group cannot yet provide statistically secured conclusions due to small patient numbers.
The therapy is not yet available outside clinical trials. Universitätsklinikum Dresden is one of the trial sites. Prof. Martin Wermke, who treats patients there, reports about 30 to 40 treatments per year. Christiane Jungermann, 41 years old, is one such patient: according to ZDF reporting, she is two years post-treatment in Dresden and metastasis-free.
In parallel, Immatics is developing a second generation: IMA203CD8 adds a CD8αβ co-receptor to the modified T cells to enhance their activity. At the ESMO-IO congress in December 2025, the company presented first data from Phase 1a dose escalation: of 69 evaluable patients, 46 percent showed measurable tumor reduction (objective response rate); in 78 percent, disease was controlled—stable or declining (disease control rate). The recommended Phase 2 dose is to be established in 2026.
What SUPRAME Must Decide
Between promising Phase 1b data and approval lies the randomized controlled trial. The SUPRAME study has been recruiting at multiple sites worldwide since December 2024, enrolling a total of 360 patients with unresectable or metastatic melanoma who previously received PD-1 immunotherapy. Unlike the Phase 1b study without a control group, anzu-cel is directly compared against standard therapy. The primary endpoint is progression-free survival (PFS), assessed by an independent review committee (BICR). A pre-specified interim analysis is to be triggered when a defined number of PFS events occur; this data cut is expected in 2026.
Immatics Chief Medical Officer Dr. Cedrik Britten deliberately framed expectations cautiously. In an interview with ZDF, he said: "We only speak of a genuine breakthrough after successful approval." Three uncertainties remain: whether Phase 1b results hold up in the randomized setting, whether manufacturing scales for potentially thousands of patients, and how the therapy will be priced. Immatics has made no public statements about therapy costs. Regarding the manufacturing process, the company reports that cell production and quality control together take 14 days, with a manufacturing success rate exceeding 95 percent.
An additional biological constraint applies: anzu-cel works only in patients carrying the HLA-A*02:01 marker, a specific cell surface molecule of the MHC class I system. This marker is present in about 40 to 45 percent of the European population. More than half of all patients are excluded. Immatics hopes that with IMA203CD8 and further variants, it will eventually reach a broader patient group.
Two Questions Before the BLA Application in 2027
If SUPRAME confirms Phase 1b results, Immatics plans to submit a Biologics License Application (BLA) to the US FDA in the first half of 2027 and commercial introduction in the second half of 2027. This would be only the second approved TCR-T therapy worldwide after Afami-cel (Tecelra) from Adaptimmune, which the FDA approved in August 2024 for rare synovial sarcoma—and the first for melanoma patients. The technology class has been regarded for years as theoretically superior to CAR-T for solid tumors; whether it delivers that promise more broadly than in the narrow synovial sarcoma indication remains open.
Immatics had liquid assets of 521.5 million US dollars as of end of March 2026, sufficient until 2028. For patients, whether the therapy actually reaches clinics in 2027 depends on two questions. First, whether SUPRAME demonstrates benefit in randomized comparison against standard therapies. Second, whether Immatics finds a pricing model that makes the therapy actually accessible for healthcare systems and patients. The first question is answered by the 2026 data cut. The second depends entirely on the company.