China-headquartered TYK medicines' third-generation EGFR inhibitor asandeutertinib achieved 91.9% intracranial objective response rate (ORR) versus 76.1% for osimertinib in the Phase II ESAONA trial (n=257) for untreated EGFR-mutant non-small cell lung cancer (NSCLC) with brain metastases. The open-label study met its primary endpoint with statistical significance (P=0.001) as assessed by blinded independent review, while systemic response rates also favoured asandeutertinib (84.7% vs 75.2%). Progression-free survival (PFS) and overall survival (OS) data remain immature for this population representing 25% of EGFR+ NSCLC cases.

Safety data showed higher grade 3+ adverse events with asandeutertinib (31.5% vs 15%), including creatine kinase elevation and QT prolongation, though interstitial lung disease rates (9.9%) were manageable. TYK plans to submit interim results with China's National Medical Products Administration (NMPA) for conditional approval before supporting an ordinary marketing application with full data. The trial continues to assess secondary endpoints in this high-unmet-need population where blood-brain barrier penetration is critical.

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