Maia Biotechnology's Ateganosine Shows Promising Efficacy in Phase II NSCLC Trial
核心洞察
Maia Biotechnology's telomerase (搜索) modifier ateganosine demonstrated a median progression-free survival of 5.6 months compared to 2.5 months with standard of care in third-line NSCLC patients.
The sequential combination of ateganosine followed by cemiplimab achieved a disease control rate of 77% versus 25-35% with chemotherapy in heavily pretreated patients.
Median overall survival reached 17.8 months, approximately 5.8 months longer than the highest OS data reported in recent real-world analyses.
Maia Biotechnology has reported positive Phase II results for its lead candidate ateganosine (THIO) in non-small cell lung cancer (NSCLC), demonstrating significant efficacy improvements when administered sequentially with Regeneron's PD-1 (搜索) inhibitor cemiplimab in heavily pretreated patients.
Phase II THIO-101 Trial Results
The multicenter, open-label Phase II THIO-101 study (NCT05208944) evaluated ateganosine followed by cemiplimab in NSCLC patients who had progressed after two or more standard of care therapy regimens. The sequential regimen achieved a median progression-free survival of 5.6 months, representing a substantial improvement over the standard of care PFS of 2.5 months.
Median overall survival reached 17.8 months, approximately 5.8 months longer than the highest OS data reported in a recent real-world analysis. The combination demonstrated a disease control rate of 77%, significantly higher than the 25-35% achieved with chemotherapy alone.
Safety Profile and Dose Considerations
Ateganosine exhibited a generally favorable safety profile, with most treatment-related adverse events being Grade 1 or 2. However, 21.5% of patients experienced Grade 3 or above treatment-related adverse events, which are considered severe.
A concerning safety signal emerged in the highest dose cohort, where Maia paused treatment in the 360mg ateganosine arm after a patient experienced Grade 4 liver function test elevation, suggesting potential liver toxicity at high doses.
Despite safety concerns, the drug showed potential for extended treatment duration, with two patients across all treatment arms successfully completing 33 cycles of therapy, which Maia suggested could "translate into longer patient survival."
Addressing Third-Line Treatment Gap
The results address a significant unmet need in advanced NSCLC, where treatment options are limited for patients in the third-line setting. Currently, standard of care revolves around chemotherapy agents like pemetrexed, docetaxel, and paclitaxel, which are often highly toxic for heavily pretreated patients.
If approved, ateganosine would be the first in its class and could be used alongside a PD-1 (搜索) inhibitor to treat patients with telomerase (搜索)-positive cancer cells, a characteristic found in 78-83% of NSCLC cases.
Competitive Landscape and Future Development
The drug faces potential competition from other late-stage pipeline candidates, including BioNTech's anti-CTLA-4 (搜索) monoclonal antibody gotistobart and AstraZeneca's ATR inhibitor ceralasertib. Merck (搜索)'s TROP-2 (搜索)-targeting antibody-drug conjugate sacituzumab tirumotecan is also being assessed in multiple Phase III trials for previously treated NSCLC with EGFR mutations.
Data from the THIO-101 trial was presented at the 2025 IASLC World Conference on Lung Cancer. Moving forward, Maia's Chair and CEO Vlad Vitoc noted that the company will further explore ateganosine's efficacy in the THIO-101 Phase II expansion trial, which began enrolling patients in July 2025.
The expansion study will assess overall response rates in advanced NSCLC patients receiving third-line therapy who were resistant to previous checkpoint inhibitor treatments and chemotherapy.