MAIA Biotechnology announces updated data from THIO-101 trial

MAIA Biotechnology (MAIA) announced updated data from its THIO-101 pivotal Phase 2 clinical trial evaluating its lead clinical candidate, THIO, sequenced with Regeneron’s (REGN) immune checkpoint inhibitor cemiplimab in patients with advanced non-small cell lung cancer who failed two or more standard-of-care therapy regimens. As of January 15, third line data showed median overall survival of 16.9 months for the 22 NSCLC patients who received at least one dose of THIO in parts A and B of the trial. The analysis demonstrated a 95% confidence interval 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 population. Studies of standard-of-care chemotherapy treatments for NSCLC in a similar setting have shown OS of 5 to 6 months. Based on its regulatory strategy, MAIA believes there could be an opportunity for accelerated FDA approval of THIO depending on final results from the ongoing expansion of the THIO-101 trial.