ASCO 2025 | IMA203, a PRAME-targeting TCR-T cell therapy, in PD1-refractory melanoma
Martin Wermke, MD, TU Dresden University of Technology, Dresden, Germany, discusses a Phase I trial (NCT03686124) of IMA203, a PRAME-targeting autologous TCR-T cell therapy, in patients with PD-1-refractory metastatic melanoma. IMA203 demonstrated a favorable safety profile, with mainly low-grade cytokine release syndrome and limited neurotoxicity. Encouraging antitumor activity was observed across multiple metastatic sites, particularly at higher doses. Confirmed responses appeared durable, with many ongoing beyond one year. This interview took place during the 2025 American Society of Clinical Oncology (ASCO) Meeting in Chicago, IL.
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Transcript
IMA203 is a PRAME-directed T-cell receptor modified T-cell product. It is an autologous T-cell product. So we’re taking T-cells from the patient and genetically transfer a T-cell receptor that recognizes the cancer testis antigen PRAME in the context of an HLA-A0201 molecule. And by recognition, these T-cells then elicit a potent anti-tumor immune response. Here we are now reporting a clinical update on patients with malignant melanoma...
IMA203 is a PRAME-directed T-cell receptor modified T-cell product. It is an autologous T-cell product. So we’re taking T-cells from the patient and genetically transfer a T-cell receptor that recognizes the cancer testis antigen PRAME in the context of an HLA-A0201 molecule. And by recognition, these T-cells then elicit a potent anti-tumor immune response. Here we are now reporting a clinical update on patients with malignant melanoma. In this cohort we are currently looking at, we included 74 patients in the total safety evaluation period and we had 27 patients in the dose escalation part and 46 patients in the phase 1b dose expansion part. Of these, 33 were suffering from melanoma, both uvea and cutaneous melanoma and these constitute the melanoma efficacy population. We saw a confirmed overall response rate of 56% in the total cohort, a median duration of responses was 12.1 months in the overall cohort, and we observed responses that lasted for longer than one and sometimes almost three years right now. Toxicity was manageable. We did see lymphodepletion-associated cytopenias. We did see a bit of cytokine release syndrome which was mainly moderate and mild. We did only infrequently see neurotoxicity due to the T cell receptor modified T cells and of note there were no IMA203 related deaths in this study. The median progression-free survival was six months for the total cohort and the median overall survival was 15.9 months which is quite encouraging in a PD-1 relapsed and refractory malignant melanoma cohort.
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