THIO Plus Libtayo Elicits Positive Responses in Advanced NSCLC

Among patients with advanced non-small cell lung cancer whose disease has progressed on two or more prior standard-of-care therapy regimens, the treatment combination of THIO (ateganosine) sequenced with the immune checkpoint inhibitor Libtayo (cemiplimab) elicited positive responses according to clinical trial data.

Findings from the phase 2 THIO-101 clinical trial were announced by the clinical-stage biopharmaceutical company MAIA Biotechnology in a news release.

As of June 30, 2025, the estimated median progression-free survival in third-line treatment with THIO and Libtayo was 5.6 months, with the comparable threshold in standard-of-care treatments being 2.5 months, according to the news release. In addition, the estimated median overall survival was 17.8 months. The news release further noted that across all patients in all treatment lines, two patients had completed 33 cycles of therapy, which speaks to THIO’s potential for extended dosing.

“THIO-101 continues to reveal impressive efficacy with observed progression-free survival of 5.6 months, which is more than double the standard-of-care [progression-free survival] of just 2.5 months. The data also demonstrate the durability of [THIO] treatment through extended treatment cycles, which is in line with consistent tolerability and low toxicity,” said MAIA Chairman and CEO Dr. Vlad Vitoc in a statement included in the news release. “We are seeking further validation of [THIO]’s strong efficacy in our THIO-101 phase 2 expansion trial, which began enrolling patients in July 2025.”

More About THIO From WCLC

CURE recently sat down with Dr. Thomas Jankowski, a medical oncologist at the Medical University of Lubin in Poland, for an interview during the 2025 IASLC World Conference on Lung Cancer in Barcelona, to discuss the science behind THIO.

“We live in an era of immunotherapy with checkpoint inhibitors, which have shown very good results, including long overall survival and progression-free survival,” said Jankowski. “However, some patients still experience disease progression. Currently, second-line treatment for these patients is only chemotherapy. There is no established immunotherapy after immunotherapy yet, although many trials are focusing on this. Right now, we don’t have immunotherapy options for patients who progress after prior immunotherapy, so we are looking for new drugs, especially for patients in second, third or later lines of treatment.

“Our drug, THIO, is a telomerase inhibitor. It is a type of chemotherapy, but in our project, we use only very limited, small doses. We use THIO not for its chemotherapy effect, but to overcome resistance to immunotherapy with checkpoint inhibitors. That is why we combine THIO with immunotherapy in our trial.

“We use Libtayo as one of the immunotherapy drugs because we have a collaboration with its manufacturer. However, I believe it could be combined with any immunotherapy drug, either anti-PD-1 or anti-PD-L1. We also have trials in other cancers using different immune checkpoint inhibitors. In this trial, we are using Libtayo.”

More About the THIO-101 Clinical Trial

The THIO-101 clinical trial is a four-part, open-label, multicenter study evaluating the safety and effectiveness of different doses of THIO sequenced with fixed doses of Libtayo among patients with advanced non-small cell lung cancer who had progressed, discontinued due to toxicity, or relapsed after receiving prior therapy with an anti-PD-1/PD-L1 therapy, according to the trial’s listing on clinicaltrials.gov.

The trial, which is being conducted at 33 international sites, is currently recruiting patients, according to the listing. With an estimated eventual enrollment of 227 patients, the trial has an approximate primary completion date of June 30, 2026, and an estimated study completion date of Dec. 31, 2026, according to the listing.

References

1. “MAIA Biotechnology Highlights Positive Efficacy Data from THIO-101 Phase 2 Clinical Trial in Non-Small Cell Lung Cancer,” news release, Sept. 11, 2025; https://ir.maiabiotech.com/news-events/press-releases/detail/150/maia-biotechnology-highlights-positive-efficacy-data-from
2. “Study Explores THIO Plus Immunotherapy in Advanced Lung Cancer,” CURE, Sept. 12, 2025; https://www.curetoday.com/view/study-explores-thio-plus-immunotherapy-in-advanced-lung-cancer
3. “THIO Sequenced With Cemiplimab in Advanced NSCLC;” https://clinicaltrials.gov/study/NCT05208944#study-overview

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