Caspofungin 50mg powder for solution for infusion vials

BackgroundRezafungin is approved for use in adults with candidemia and/or invasive candidiasis (IC) based on data from the ReSTORE trial (NCT03667690), which demonstrated noninferior efficacy to caspofungin. For regulatory purposes, an additional cohort of patients from China was recruited to ReSTORE. Here, we compared rezafungin and caspofungin in patients with candidemia and/or IC through analysis of the ReSTORE global data plus the China extension study.MethodsAdults with candidemia/IC were randomized (1:1) to receive weekly rezafungin (400/200 mg) or daily caspofungin (70/50 mg) for ≤28 days. Noninferiority was concluded for primary efficacy endpoints if the upper bound of the 95% confidence interval (CI) was below 20% for Day 30 all-cause mortality and if the weighted lower bound was above -20% for Day 14 global cure. Additional efficacy outcomes and safety were evaluated.ResultsOverall, 246 patients were randomized (122 rezafungin and 124 caspofungin). Noninferiority was demonstrated for both primary endpoints. Day 30 all-cause mortality was 25.2% and 24.8% (treatment difference 0.4%; 95% CI -10.8, 11.6) and Day 14 global cure was 56.5% and 57.3% (weighted treatment difference -1.0%; 95% CI -13.5, 11.6) with rezafungin versus caspofungin, respectively. Day 5 mycological eradication was numerically higher (68.7% vs 63.2%) and time to negative blood culture was numerically shorter (median 26.5 vs 38.8 h). Safety was comparable between groups; 53.3% (64/120; rezafungin) and 53.7% (66/123; caspofungin) of patients experienced serious adverse events.ConclusionsThis analysis confirmed the overall efficacy and safety of rezafungin demonstrated in ReSTORE, with early efficacy related to front-loaded exposure.

Abstract licence: CC BY-NC-ND

BackgroundThe 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.ObjectivesWe 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.MethodsPatients 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]).ResultsAll-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.ConclusionsRezafungin 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 registrationClinicalTrials.gov identifier: NCT03667690.

Abstract licence: CC BY