MAIA Biotechnology's Experimental Cancer Drug Shows Tripled Survival Vs. Standard Chemotherapy In Pretreated Lung Cancer Patients

MAIA Biotechnology, Inc. MAIA on Thursday revealed updated data from its THIO-101 pivotal Phase 2 clinical trial.

The trial is evaluating its lead clinical candidate, ateganosine (THIO), sequenced with Regeneron Pharmaceutical Inc’s REGN immune checkpoint inhibitor (CPI) cemiplimab (Libtayo) for advanced non-small cell lung cancer (NSCLC) who are resistant to immune therapy and chemotherapy.

As of May 15, third line (3L) data showed median overall survival (OS) of 17.8 months for the 22 NSCLC patients who received at least one dose of ateganosine (the intent-to-treat population) in parts A and B of the trial. The updated analysis demonstrates a 95% confidence interval (CI) lower bound of 12.5 months and a 99% CI lower bound of 10.8 months.

Also Read: MAIA Biotechnology’s Lung Cancer Drug Shows Promising Long-Term Benefits In Advanced Patients

The treatment has been generally well-tolerated to date in this heavily pretreated population.

At the data cutoff, the patient with the longest survival in the trial had completed 32 cycles of therapy and had 24.3 months survival.

Studies of standard-of-care (SOC) chemotherapy treatments for NSCLC in a similar setting have shown OS of 5 to 6 months.

“This new benchmark of 17.8 months median OS is nearly triple the recognized SOC data for third-line NSCLC found in the medical literature. We believe this is a substantial indicator of the potential ateganosine has to shift the NSCLC treatment landscape,” said MAIA Chairman and CEO Vlad Vitoc.

MAIA’s multiple potential regulatory pathways for ateganosine could provide accelerated FDA approval and robust exclusivity in NSCLC, with a potential FDA decision as early as next year.

The company announced a new partial response (PR) was identified in a patient after 20 months of treatment. A partial response is defined as a decrease in tumor size of at least 30%.

“The patient remained on treatment and we observed stable disease for more than twenty months before the partial response was identified, highlighting the efficacy, safety and low toxicity of the treatment,” Vitoc added.

Price Action: MAIA stock is up 11.7% at $1.97 at the last check on Thursday.

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