A PHASE III trial has shown that rezivertinib offers superior progression-free survival compared to gefitinib as a first-line treatment for patients with EGFR-mutated locally advanced or metastatic non-small-cell lung cancer (NSCLC).
The REZOR study was a multicentre, double-blind, randomised trial conducted across 50 hospitals in China. Eligible patients with histologically or cytologically confirmed NSCLC harbouring EGFR exon 19 deletion or exon 21 Leu858Arg mutation were enrolled and randomly assigned (1:1) to receive either rezivertinib (180 mg/day) or gefitinib (250 mg/day). Treatment continued until disease progression, unacceptable toxicity, or other criteria for discontinuation were met. The primary endpoint was progression-free survival, assessed by masked independent central review (MICR), and the study remains in follow-up.
Between July 2019–February 2022, 369 patients were randomly assigned to either rezivertinib (n=184) or gefitinib (n=185). The median MICR-assessed progression-free survival was significantly longer in the rezivertinib group (19.3 months; 95% CI: 13.8–22.1) compared to the gefitinib group (9.6 months; 95% CI: 8.4–11.3), with a hazard ratio of 0.48 (95% CI: 0.36–0.63; P<0.0001). The median duration of exposure was also longer in the rezivertinib group (16.0 months vs 11.0 months). Grade 3 or higher treatment-emergent adverse events occurred in 45% of rezivertinib-treated patients and 43% of gefitinib-treated patients. Treatment-related adverse events were comparable between the groups (23% in both). One patient in the rezivertinib group died from a treatment-related adverse event (pneumonia and interstitial lung disease).
These findings highlight rezivertinib as a promising first-line treatment option for EGFR-mutated NSCLC, demonstrating superior efficacy while maintaining a comparable safety profile to gefitinib.
Ada Enesco, EMJ
Reference
Shi Y et al. Rezivertinib versus gefitinib as first-line therapy for patients with EGFR-mutated locally advanced or metastatic non-small-cell lung cancer (REZOR): a multicentre, double-blind, randomised, phase 3 study. Lancet Respir Med. 2025;DOI: 10.1016/S2213-2600(24)00417-X.
