Abstract
BACKGROUND: The global double-blind, randomised, Phase 3 ReSTORE trial (NCT03667690) demonstrated noninferiority of rezafungin versus caspofungin for all-cause mortality at Day 30 and global cure at Day 14 in patients with candidemia and/or invasive candidiasis. OBJECTIVES: We report outcomes for patients from China (ReSTORE China), comprising participants enrolled in the original ReSTORE trial (n = 11) and from an extended, China-only phase (n = 47) implemented to fulfill Chinese regulatory requirements. METHODS: Patients with candidemia/invasive candidiasis were randomised 1:1 to intravenous rezafungin (400 mg loading, then 200 mg once weekly) or caspofungin (70 mg loading, then 50 mg once daily) for ≤ 4 weeks. Primary endpoints were all-cause mortality at Day 30 and global cure at Day 14 in the modified intent-to-treat population. Between October 2018 and March 2024, 58 patients were randomised and received study treatment (rezafungin n = 28 [modified intent-to-treat n = 27], caspofungin n = 30 [modified intent-to-treat n = 28]). RESULTS: All-cause mortality at Day 30 was 33.3% (9/27) for rezafungin versus 35.7% (10/28) for caspofungin (difference -2.4% [95% confidence interval -27.0-22.6]). Global cure at Day 14 was 48.1% (13/27) versus 46.4% (13/28), respectively (weighted difference 0.3% [95% confidence interval -25.4-26.3]). Day 5 and 14 mycological eradication rates were 70.4% and 63.0% for rezafungin versus 71.4% and 67.9% for caspofungin, respectively. Safety and tolerability profiles were similar between groups. CONCLUSIONS: Rezafungin demonstrated similar efficacy and safety to caspofungin in the ReSTORE China cohort. These findings support the primary ReSTORE analysis and suggest that rezafungin could provide a new treatment option for candidemia/invasive candidiasis in China. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03667690.