Multicenter phase 3 study of first-line rezivertinib versus gefitinib for EGFR-mutated locally advanced or metastatic non-small cell lung cancer

Rezivertinib is an orally available third-generation EGFR TKI. The phase 3 REZOR study, at 50 centers in China, compared rezivertinib versus gefinib as first-line therapy for EGFR-mutated locally advanced or metastatic non-small cell lung cancer. The median progression-free survival by masked independent central review was 19.3 months in the rezivertinib group and 9.6 months in the gefitinib group (HR 0.48; p<0.0001), with consistent results in the prespecified subgroup efficacy analysis. Grade 3 or higher treatment-emergent adverse events were reported for 45% of patients in the rezivertinib group and 43% of patients in the gefitinib group, and treatment-related adverse events in 23% versus 23%. One patient in the rezivertinib group died from treatment-related pneumonia and interstitial lung disease. The authors conclude that these results suggest that rezivertinib is a potential first-line option for patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer.