Clinical TrialMay 31, 2026, 09:01 AM
Immatics IMA401 shows deep, durable responses in Phase 1 solid tumor trial
AI Summary
Immatics N.V. announced extended positive Phase 1 clinical trial data for its TCR bispecific candidate IMA401 targeting MAGEA4/8 in heavily pretreated solid tumor patients. The data, presented at ASCO and published in Nature Medicine, showed deep and durable responses in various indications, including a 29% confirmed ORR and 8.8 months mDOR in head and neck cancer, alongside a favorable tolerability profile. Building on these results, Immatics has initiated enrollment for a Phase 1 combination cohort evaluating IMA401 with IMA402 (PRAME bispecific) in squamous cell non-small cell lung cancer, with initial data anticipated in 2027.
Key Highlights
- IMA401 achieved deep and durable responses in melanoma and head and neck cancer, with an initial signal in lung cancer.
- In head and neck cancer, IMA401 at RP2D showed a 29% confirmed ORR (4/14), 64% DCR (9/14), and mDOR of 8.8 months.
- All responders in head and neck cancer achieved deep tumor reduction (60-100%), with three of four ongoing at data cutoff.
- IMA401 demonstrated favorable tolerability at RP2D, both as monotherapy and with pembrolizumab, with no Grade 3+ CRS.
- The IMA401/IMA402 combination cohort is now enrolling for squamous cell non-small cell lung cancer (sqNSCLC).
- First data from the IMA401/IMA402 combination cohort are expected in 2027.
- Preclinical data show >90% of sqNSCLC patients are positive for PRAME and/or MAGEA4/8, supporting combination therapy.
- The addressable patient population for metastatic sqNSCLC in the US and EU5 is estimated at 40,000 patients per year.
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