MAIA Biotechnology has reported that treatment with THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) in sequential combination with cemiplimab (Libtayo) offered 100% disease control rate (DCR) for patients with second-line non-small cell lung cancer (NSCLC) in a Phase II clinical trial.
Dubbed THIO-101, the open-label, multicentre, dose-finding Phase II trial is assessing the anti-tumour activity of THIO following PD-(L)1 inhibition.
It is analysing whether low doses of THIO given before cemiplimab, an anti-PD-1 of Regeneron, can improve immune responses in advanced NSCLC patients.
The patient population includes individuals who were unresponsive or resistant to a checkpoint inhibitor, as well as those whose cancer advanced following first-line checkpoint inhibitor treatment.
According to the positive initial efficacy trial findings, preliminary DCRs of 100% and 88% were reported in second-line and third-line trial subjects, respectively.
DCRs across all tested dose levels met the defined statistical thresholds earlier than predicted, allowing the expedition of the trial to the next stage.
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THIO is an investigational, telomere-targeting agent in the clinical development stage.
MAIA Biotechnology CEO Vlad Vitoc said: “We have also observed unprecedented high DCRs in third-line, with an 88% control rate, with treatment of THIO followed by cemiplimab.
“The results are even more remarkable given patients in this population have previously failed treatment with a checkpoint inhibitor.
“These exceptional preliminary results underscore our confidence in advancing the trial to bring our novel treatment to advanced-stage NSCLC patients.”
In April this year, the company reported positive topline data from Part A of the Phase ll THIO-101 trial of THIO to treat advanced NSCLC.