WCLC 2025 - Posters & ePosters-P3.12.07 Rezivertinib in EGFR-Mutated NSCLC Patients With Cns Metastases: Cns Efficacy From Phase 3 RAZOR Study

P3.12.07 Rezivertinib in EGFR-Mutated NSCLC Patients With Cns Metastases: Cns Efficacy From Phase 3 RAZOR Study

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The Phase 3 RAZOR study (NCT03866499) evaluated the efficacy of rezivertinib versus gefitinib as first-line treatment in 369 treatment-naïve patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutations (Ex19del or L858R). This analysis specifically focuses on central nervous system (CNS) outcomes in patients with baseline CNS metastases.<br /><br />Patients with stable, asymptomatic CNS metastases were included, undergoing baseline and follow-up CT/MRI brain scans. The CNS full analysis set (cFAS) comprised 159 patients (rezivertinib: 81; gefitinib: 78), while 25 patients with measurable CNS lesions formed the CNS evaluable-for-response set (cEFR; rezivertinib: 12; gefitinib: 13). CNS efficacy was assessed by blinded independent central review (BICR) per RECIST v1.1 and RANO-BM criteria.<br /><br />Results demonstrated that, in the cEFR population, the confirmed CNS objective response rates (ORR) were 83.3% for rezivertinib and 76.9% for gefitinib. In the larger cFAS, median CNS progression-free survival (PFS) was significantly longer with rezivertinib at 24.9 months versus 15.2 months for gefitinib (hazard ratio [HR] 0.58; 95% CI, 0.34-0.99; P=0.0473). Subgroup analyses showed that in patients with baseline plasma EGFR mutation positivity, rezivertinib achieved a notable CNS PFS benefit (median not reached vs. 8.5 months; HR 0.34; P=0.0142). Safety profiles for rezivertinib were manageable.<br /><br />In conclusion, rezivertinib demonstrated superior CNS efficacy compared to gefitinib in first-line treatment of EGFR-mutated advanced NSCLC patients with CNS metastases, while maintaining a manageable safety profile. These CNS findings support rezivertinib's role as an effective treatment option for this population. Further validation in larger studies is anticipated.

Asset Subtitle

Jirong Peng

Meta Tag

Speaker Jirong Peng

Topic Metastatic Non-small Cell Lung Cancer – Targeted Therapy

Keywords

Phase 3 RAZOR study

rezivertinib

gefitinib

non-small cell lung cancer

NSCLC

EGFR mutations

central nervous system metastases

CNS progression-free survival

objective response rate

first-line treatment