Tanja Obradovic: Can we expect new EGFR TKI to surpass osimertinib in primary tumor and intracranial progression of NSCLC

Tanja Obradovic posted on LinkedIn:

“Can we expect new EGFR TKI that can significantly surpass osimertinib in both controlling primary tumor as well as intracranial progression of NSCLC patients soon?

Third-generation EGFR TKI, osimertinib, has been dominant TKI in practice for treatment of NSCLC patients with EGFRmut. It has been formulated to target intracranial lesions more effectively via augmented blood-brain barrier penetration resulting in increased CSF drug concentration that has shown promise in controlling CNS progression as seen in studies with lower rates of intracranial progression in both adjuvant and palliative settings in NSCLC patients but there is a large space for improvement.

China-based Biotech TYK Medicines just entered main board of the Hong Kong Stock Exchange (HKSE), raising US$74.32 million to commercialize its lead compound, EGFR TK inhibitor TY9591. Ongoing Phase III trial (FLETEO) comparing TY9591 vs osimertinib has projected primary completion mid-2025 (trial link).

Judging by company preparing for commercialization this read out may be coming sooner. Listing on HKSE also demonstrates increasing trend of Asia-based Biotechs independently driving assets over late stage development and into launch. Additional strategic issue worthwhile thinking is if considering solely China-based clinical development of TY9591 future registration and launch would indeed remain regionally limited or if outcome strength of the pivotal trial would warrant global plans.”

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Source: Tanja Obradovic/LinkedIn

Tanja Obradovic is the Vice President of Oncology Scientific Affairs at ICON PLCh. She has over 20 years of clinical research experience and has led major pharmaceutical companies for 13 years. Her research focuses on small molecules, antibodies, cell and gene therapy, and major immunotherapy of PD1 inhibitors.