The multicentre, open-label, dose-finding trial aims to assess anti-tumour activity of THIO in NSCLC patients. Credit: Marko Aliaksandr / Shutterstock.

MAIA Biotechnology has reported positive efficacy findings from its Phase II THIO-101 clinical trial of THIO sequenced with cemiplimab (Libtayo) to treat advanced non-small cell lung cancer (NSCLC).

THIO, also known as 6-thio-2’-deoxyguanosine, is an investigational telomere-targeting agent.

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The multicentre, open-label, dose-finding trial is designed to assess the anti-tumour activity of THIO followed by PD-(L)1 inhibition.

It is designed to analyse if low doses of THIO administered before cemiplimab can boost and prolong the immune response in advanced NSCLC patients who have not responded or have developed resistance to first-line treatments containing another checkpoint inhibitor.

The trial’s two primary objectives are to assess the tolerability and safety of THIO as an anticancer therapy and a priming immune activator, as well as to analyse its clinical efficacy using overall response rate (ORR) as the primary endpoint.

THIO treatment after cemiplimab was found to be well-tolerated in a heavily pre-treated population so far.

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The ORR was 38% in the efficacy evaluable subjects for the combination of THIO 180mg plus cemiplimab in third-line NSCLC patients who did not respond to immune checkpoint inhibitors in previous lines of therapy, irrespective of chemotherapy status.

Two patients in the 180mg dose cohort did not have recorded scans at the data cutoff, yet safety remained consistent with prior data.

MAIA chairman and CEO Vlad Vitoc said: “As an impressive measure of efficacy, the strong response rate of 38% in third-line treatment supports our premise that THIO administration prior to cemiplimab can improve tumour responses to immunotherapy in advanced NSCLC patients resistant to CPIs and other standard treatments.

“We are encouraged by the excellent efficacy findings in THIO-101 to date, adding impressive ORR to unprecedented disease control rates (DCR), and further demonstrating the potential of our first-in-class treatment to redefine the standard of care for NSCLC patients.”

Last month, the company concluded subject enrolment in the THIO-101 trial of THIO plus cemiplimab to treat advanced NSCLC patients.