The 2026 American Society of Clinical Oncology (ASCO) Annual Meeting will be held in Chicago, USA, from May 29^th to June 2^nd (local time). The interim analysis of the pivotal Phase II ESAONA study comparing asandeutertinib (TY-9591), independently developed by TYK Medicines (Stock code: 02410.HK), with osimertinib as first-line treatment for patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) and brain metastases (BM), has been accepted as a Late-Breaking Abstract (LBA) due to its major clinical significance and will be presented in an Oral Abstract Session by the principal investigator, Professor Yuankai Shi from the Cancer Hospital, Chinese Academy of Medical Sciences.

• Abstract Title: Efficacy and Safety of Asandeutertinib versus Osimertinib as First-line Therapy in EGFR-Mutated NSCLC Patients with Brain Metastases: Interim Analysis of an Open-Label, Multicenter, Randomized, Pivotal Study (ESAONA).
• Abstract ID: #LBA2007
• Session Type (Title): Oral Abstract Session (Central Nervous System Tumors)
• Principal Investigator: Professor Yuankai Shi, Cancer Hospital, Chinese Academy of Medical Sciences
• Presentation Time: May 30, 2026, 05:12 PM – 05:24 PM (Chicago Time/CDT)

May 31, 2026, 06:12 AM – 06:24 AM (Beijing Time/UTC+8)

ESAONA Study：

This is the first pivotal study to evaluate a third-generation EGFR-TKI as monotherapy versus osimertinib in a head-to-head superiority design specifically for EGFR-mutated NSCLC patients with brain metastases(BM). Prespecified interim analysis results showed that, compared with osimertinib, asandeutertinib significantly improved intracranial objective response rate (iORR) and intracranial progression-free survival (iPFS) with a manageable safety profile in these patients.

Based on the results of ESAONA, asandeutertinib’s conditional New Drug Application (NDA) has been accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) and granted priority review, which will provide a novel and highly effective targeted therapy strategy for advanced EGFR-mutated NSCLC patients with BM.

About Asandeutertinib
Asandeutertinib, developed by TYK Medicines, is an oral, new-generation, highly selective EGFR-TKI that exhibits high potency, ATP-competitive binding, and an irreversible mechanism of action. As a deuterated analog of osimertinib that’s already on the market, it exhibits distinct pharmacokinetic characteristics that significantly reduce the generation of the toxic metabolite AZD5104 (TY9591-D1), offering clear clinical advantages. It has shown significant efficacy, particularly in NSCLC patients with brain metastases and EGFR L858R mutation. TYK Medicines has initiated multiple clinical trials in China evaluating asandeutertinib as monotherapy and in combination for treating advanced NSCLC.