2024 World Conference on Lung Cancer (WCLC) - Posters-P1.12A.07 A Phase 1 Study of TY-9591 in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients with EGFR Positive Mutation.

P1.12A.07 A Phase 1 Study of TY-9591 in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients with EGFR Positive Mutation.

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This document presents a Phase 1 study of TY-9591, a third-generation EGFR tyrosine kinase inhibitor (TKI), in patients with advanced non-small cell lung cancer (NSCLC) with EGFR mutations. The motivation for the study stems from the insufficient efficacy of current third-generation TKIs, especially in cases with brain metastases or L858R mutations. TY-9591 aims to address these gaps, showcasing potential for improved efficacy and decreased side effects by reducing the exposure to toxic metabolites compared to similar treatments like osimertinib.<br /><br />The study encompassed a first-in-human, dose escalation and expansion approach, involving 105 patients with advanced or metastatic EGFR mutation-positive NSCLC who have progressed on prior treatments. The primary goal was to assess safety and efficacy, with secondary endpoints including overall response rate (ORR), disease control rate (DCR), and progression-free survival (PFS).<br /><br />Results indicate that TY-9591 is safe and well-tolerated, with no significant safety issues like interstitial lung disease or cardiomyopathy, though QTc interval prolongation was noted. It demonstrated high efficacy, particularly for L858R mutations and brain metastases, observing a higher ORR and DCR at a 160 mg dose compared to 80 mg and 120 mg. The intracranial ORR in patients with measurable brain lesions was 90.9%, predominantly seen in the 160 mg group.<br /><br />Early findings suggest promising outcomes with TY-9591, sparking ongoing comparative studies against osimertinib in Phase 2 and Phase 3 trials. These aim to further verify TY-9591's superiority in treating NSCLC patients with challenging mutations or brain metastases. Overall, this study highlights TY-9591 as a potential advanced treatment option, warranting further research into its long-term benefits and optimal dosing.

Asset Subtitle

Baohui Han

Meta Tag

Speaker Baohui Han

Topic Metastatic NSCLC – Targeted Therapy

Keywords

TY-9591

EGFR mutations

non-small cell lung cancer

third-generation TKI

brain metastases

L858R mutations

dose escalation

safety and efficacy

progression-free survival

osimertinib