Efficacy and Safety of Rezafungin Versus Caspofungin for the Treatment of Candidemia and Invasive Candidiasis in a China Cohort of a Double-Blind, Randomised, Phase 3 Trial (ReSTORE China).

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.