WCLC 2025 - Posters & ePosters-P3.12.31 Rezivertinib in Advanced NSCLC Patients With EGFR T790M Mutation via Tissue/Plasma Samples: Pooled Analysis of 2 Clinical Studies

P3.12.31 Rezivertinib in Advanced NSCLC Patients With EGFR T790M Mutation via Tissue/Plasma Samples: Pooled Analysis of 2 Clinical Studies

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This pooled analysis of two clinical studies evaluated the efficacy and safety of rezivertinib (BPI-7711), a novel third-generation EGFR tyrosine kinase inhibitor, in advanced non-small cell lung cancer (NSCLC) patients harboring the EGFR T790M mutation detected in both tissue and plasma samples. Patients included had progressed on first- or second-generation EGFR-TKIs and were treated with 180 mg of rezivertinib daily.<br /><br />Among 89 patients analyzed, those with EGFR T790M mutation detected in tissue but not plasma (group B) demonstrated superior outcomes compared to those with mutations detected in both tissue and plasma (group A). The objective response rate (ORR) was 78.3% in group B versus 55.0% in group A. Disease control rate (DCR) was 100% in group B versus 90.0% in group A, with statistically significant differences. Median progression-free survival (PFS) was notably longer in group B at 16.7 months compared to 6.5 months in group A (hazard ratio 0.26, P=0.0001). Overall survival (OS) showed a similar trend, with group B not reached, while group A had median OS of 15.5 months (HR 0.28, P=0.0006).<br /><br />Rezivertinib displayed encouraging systemic and central nervous system efficacy with a manageable safety profile. Importantly, baseline plasma positivity for EGFR T790M mutation was associated with poorer outcomes, likely reflecting higher tumor burden. The data support continued use of tissue sampling as the primary method for EGFR T790M detection, with plasma sampling as a non-invasive alternative, especially in patients with high tumor burden. Plasma mutation detection may also provide prognostic information in clinical practice.<br /><br />In conclusion, rezivertinib shows promise in treating EGFR T790M-mutated advanced NSCLC, with efficacy varying by mutation detection method, highlighting the prognostic value of plasma-based testing and the importance of personalized treatment strategies.

Asset Subtitle

Yanqiu Zhao

Meta Tag

Speaker Yanqiu Zhao

Topic Metastatic Non-small Cell Lung Cancer – Targeted Therapy

Keywords

rezivertinib

EGFR T790M mutation

non-small cell lung cancer

third-generation EGFR-TKI

tissue mutation detection

plasma mutation detection

objective response rate

progression-free survival

overall survival

tumor burden