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MAIA Biotechnology Announce Efficacy Updates For Phase 2 THIO-101 Trial In Advanced Non-Small Cell Lung Cancer; Median Overall Survival From THIO Treatment Extends To 16.9 Months

Benzinga·02/04/2025 13:53:00
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  • Median overall survival (OS) from THIO treatment extends to 16.9 months
  • Newest data strengthens regulatory strategy

MAIA Biotechnology, Inc., (NYSE:MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced positive updated data from its THIO-101 pivotal Phase 2 clinical trial evaluating its lead clinical candidate, THIO, sequenced with Regeneron's immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who failed two or more standard-of-care therapy regimens.

As of January 15, 2025, third line (3L) data showed median overall survival (OS) of 16.9 months for the 22 NSCLC patients who received at least one dose of THIO (the intent-to-treat population) in parts A and B of the trial. The analysis demonstrated a 95% confidence interval (CI) lower bound of 12.5 months and a 99% CI lower bound of 10.8 months. The treatment has been generally well-tolerated to date in this heavily pre-treated population1. Studies of standard-of-care (SOC) chemotherapy treatments for NSCLC in a similar setting have shown OS of 5 to 6 months.2