THIO Followed by Cemiplimab Leads to Potential OS Benefit in Pretreated Advanced NSCLC

Treatment with the telomere-targeting agent THIO followed by cemiplimab (Libtayo) led to a potential overall survival (OS) benefit in patients with advanced non–small cell lung cancer (NSCLC) whose disease progressed following 2 or more standard-of-care (SOC) therapy regimens, according to data from the phase 2 THIO-101 trial (NCT05208944).¹

Findings showed that 16 patients had an OS follow-up duration that surpassed 12 months, including 9 patients who were treated with THIO and cemiplimab in the third-line setting. Patients who received the regimen in the third line had a median OS follow-up of 10.6 months.

In a news release from MAIA Biotechnology, the developer of THIO, the company noted that published data indicate that the median OS for patients with advanced NSCLC treated in the third-line setting with SOC therapy is 5.8 months.

“THIO is showing a survival benefit for patients with advanced NSCLC. As our follow-up continues, we have noted that 3 of the earliest patients enrolled are approaching 17-month survival. We’re on track to achieve our survival goals in third-line therapy,” Vlad Vitoc, MD, chairman and chief executive officer of MAIA Biotechnology, said in the news release. “THIO’s outperformance to date supports our thesis that our telomere-targeting agent could become a treatment option for [patients] suffering from advanced NSCLC.”

Previously reported data from THIO-101 showed that in patients treated in the third-line setting, the disease control rate (DCR) was 85%, and 65% of patients had crossed the 5.8-month OS threshold. In patients treated in the third-line setting with the optimal dose of THIO at 180 mg, the median progression-free survival (PFS) was 5.5 months, the 6-month OS rate was 78%, and 75% of patients crossed the 5.8-month OS threshold. Additionally, the overall response rate was 38%.²

THIO-101 is a multicenter, open-label, dose-finding trial enrolling patients at least 18 years of age with histologically or cytologically confirmed stage III or IV NSCLC whose disease either progressed or relapsed after treatment with an immune checkpoint inhibitor. Key inclusion criteria consist of at least 1 measurable target lesion per RECIST 1.1 criteria; a life expectancy of more than 12 weeks; an ECOG performance status of 0 or 1; and adequate organ function.³

Patients are being excluded if they have untreated or symptomatic central nervous system metastases; active gastrointestinal bleeding; conditions requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study treatment; and active, uncontrolled bacterial, viral, or fungal infections that require systemic therapy within 2 weeks of screening.

Part A of the trial was a safety lead-in portion, where patients in cohort 1 received THIO at 120 mg per day on days 1 to 3 every 3 weeks plus cemiplimab at 350 mg on day 5; those in cohort 2 were given THIO at 60 mg per day on days 1 to 3 every 3 weeks plus 350 mg of cemiplimab on day 5. In part B, THIO is being given at 20 mg, 60 mg, or 120 mg per day on days 1 to 3 every 3 weeks, plus cemiplimab at 350 mg on day 5. In part C, patients are receiving 180 mg of THIO per day on days 1 to 3 plus cemiplimab at 350 mg on day 5 of every 3-week cycle.

The study’s primary end points are the incidence of dose-limiting toxicities, safety, ORR, and DCR. Secondary end points include duration of response, PFS, and OS. On-target activity of THIO as assessed by circulating tumor cells, as well as genomic DNA damage, are exploratory end points.

References

1. MAIA Biotechnology announces positive survival updates in phase 2 study of THIO in non-small cell lung cancer. News release. MAIA Biotechnology. September 10, 2024. Accessed September 10, 2024. https://ir.maiabiotech.com/news-events/press-releases/detail/113/maia-biotechnology-announces-positive-survival-updates-in
2. MAIA Biotechnology reveals new clinical data showing THIO’s strong efficacy in non-small cell lung cancer. News release. MAIA Biotechnology. June 4, 2024. Accessed September 10, 2024. https://ir.maiabiotech.com/news-events/press-releases/detail/108/maia-biotechnology-reveals-new-clinical-data-showing
3. THIO sequenced with cemiplimab in advanced NSCLC. ClinicalTrials.gov. Updated August 31, 2023. Accessed September 10, 2024. https://clinicaltrials.gov/study/NCT05208944