other material
confidence high
sentiment positive
materiality 0.75
MAIA plans Phase 3 pivotal trial of THIO+CPI vs chemo in NSCLC patients
MAIA Biotechnology, Inc.
- Phase 3 trial THIO-104 to enroll up to 300 patients with third-line NSCLC.
- Primary endpoint is overall survival; THIO sequenced with checkpoint inhibitor vs investigator's choice chemo.
- Patient enrollment expected to begin H2 2025 in Asia, Europe, and U.S.
- Based on THIO-101 Phase 2 data that consistently outperformed standard options.
- Trial designed to support FDA commercial approval of THIO.