MAIA completes Phase 2 enrollment and reaches 65 patients in Phase 3 lung cancer study

MAIA Biotechnology completed Part C enrollment in its Phase 2 THIO-101 study of ateganosine followed by cemiplimab for advanced non-small cell lung cancer. Its pivotal Phase 3 THIO-104 study has enrolled 65 patients, or 65% of its enrollment goal, with the company targeting 100 enrolled and dosed patients by the end of 2026. MAIA plans an interim THIO-104 analysis in 2027.

The update advances MAIA's pivotal trial toward its planned interim readout. The company reported a 90.5% interim disease control rate in the efficacy-evaluable population for the Phase 2 combination, though that result is not a Phase 3 efficacy outcome.

  • 1MAIA completed enrollment for Part C of the Phase 2 THIO-101 trial in advanced non-small cell lung cancer.
  • 2The Phase 3 THIO-104 trial had enrolled 65 patients, equal to 65% of MAIA's target.
  • 3MAIA aims to enroll and dose 100 patients in THIO-104 by the end of 2026.
  • 4The company reported a 90.5% interim disease control rate for the combination in the efficacy-evaluable population with at least one post-treatment scan.
  • 5MAIA expects an interim analysis of THIO-104 in 2027.
  • 6The FDA granted Fast Track designation to ateganosine for non-small cell lung cancer in July 2025.

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