ASCO 2026 | IMA401, a MAGEA4/8-targeted T-cell engager, in recurrent/refractory solid tumors
Martin Wermke, MD, TU Dresden University of Technology, Dresden, Germany, discusses first-in-human results from a Phase I/II basket study (NCT05359445) of IMA401, a bispecific T-cell receptor-based T-cell engager targeting MAGEA4 and MAGEA8, in patients with advanced solid tumors. Results demonstrated favorable tolerability without reaching the maximum tolerated dose, with promising antitumor activity observed in head and neck cancer, melanoma, and squamous non-small cell lung cancer (sqNSCLC). This interview took place during the 2026 American Society of Clinical Oncology (ASCO) Meeting in Chicago, IL.
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Transcript
IMA401 is a novel bispecific T-cell engager that uses a T-cell receptor-derived antigen binding domain. It binds to a cancer testis antigen called MAGE-A4 that is expressed in a wide variety of solid tumors, including non-small cell lung cancer and squamous head and neck carcinoma. Overall, we included 61 patients in that first-in-human dose escalation trial. We saw responses in a wide variety of tumors, including squamous non-small cell lung cancer, melanoma, and head and neck cancer...
IMA401 is a novel bispecific T-cell engager that uses a T-cell receptor-derived antigen binding domain. It binds to a cancer testis antigen called MAGE-A4 that is expressed in a wide variety of solid tumors, including non-small cell lung cancer and squamous head and neck carcinoma. Overall, we included 61 patients in that first-in-human dose escalation trial. We saw responses in a wide variety of tumors, including squamous non-small cell lung cancer, melanoma, and head and neck cancer. In head and neck cancer, we had a confirmed overall response rate of 29%, with many of these responses being durable, a median duration of response being above eight months, and three out of four responses ongoing at the time of data cutoff. The safety profile of this compound was quite good. So we had mainly mild and transient mechanism of action-related toxicity, so cytokine release syndrome occurring in 38% of the patients, but only being of grade one and two. We did see a bit of lymphopenia, which is mechanism of action-related and transient. We did see neutropenia. However, this was manageable with GCSF and dexamethasone pre-medication. There were no IMA401-associated deaths. The MTD has not been formally reached. So this is really looking like a drug that is easy to combine with other drugs.
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