China-based TYK Medicines, Inc. (HKG: 2410) announced on August 14, 2025, that the results of the pivotal Phase II registration clinical trial (NCT05948813) for its self-developed innovative drug, asandeutertinib (TY-9591) tablets, have been accepted as a mini oral presentation at the 2025 World Conference on Lung Cancer (WCLC), hosted by the International Association for the Study of Lung Cancer (IASLC).
Clinical Trial Results
The study enrolled 257 patients with EGFR-mutated non-small cell lung cancer (NSCLC) and brain metastases. Interim analysis of 224 subjects showed that the intracranial objective response rate (iORR) assessed by blinded independent central review (BICR) was 91.9% (95% CI: 85.2-96.2%) in the asandeutertinib group, compared to 76.1% (95% CI: 67.2-83.6%, P=0.001) in the osimertinib group. Investigator-assessed iORR was 91.0% (95% CI: 84.1-95.6%) in the asandeutertinib group versus 75.2% (95% CI: 66.2-82.9%, P=0.002) in the osimertinib group. A favorable trend was observed for the systemic objective response rate (ORR), with asandeutertinib at 84.7% and osimertinib at 75.2%.
Safety Profile
The incidence of Grade ≥3 treatment-related adverse events was 31.5% in the asandeutertinib group and 15.0% in the osimertinib group. The most common Grade ≥3 adverse reactions in the asandeutertinib group included increased creatine phosphokinase, prolonged QTcf interval, granulocytopenia, and leukopenia. The incidence of interstitial lung disease (ILD) was 9.9% and QTcf prolongation was 4.5%, both within a manageable range.
Drug Profile
Asandeutertinib (TY-9591) is a highly selective small-molecule inhibitor developed by TYK Medicines, targeting classic EGFR gene mutations. It aims to address the unmet clinical need for non-small cell lung cancer with brain metastases under current treatment standards. The efficacy data for intracranial progression-free survival (iPFS), progression-free survival (PFS), and overall survival (OS) are not yet mature.-Fineline Info & Tech
