Abstract Background Rezafungin is approved for use in adults with candidemia and/or invasive candidiasis based on data from the ReSTORE trial (NCT03667690), which demonstrated non-inferior 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 invasive candidiasis through analysis of the ReSTORE global data plus the China extension study. Methods Adults with candidemia/invasive candidiasis were randomized (1:1) to receive weekly rezafungin (400/200 mg) or daily caspofungin (70/50 mg) for ≤28 days. Non-inferiority 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. Results Overall, 246 patients were randomized (122 rezafungin, 124 caspofungin). Non-inferiority 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% versus 63.2%) and time to negative blood culture numerically shorter (median 26.5 versus 38.8 hours). Safety was comparable between groups; 53.3% (64/120; rezafungin) and 53.7% (66/123; caspofungin) of patients experienced serious adverse events. Conclusions This analysis confirmed the overall efficacy and safety of rezafungin demonstrated in ReSTORE, with early efficacy related to front-loaded exposure.
Thompson et al. (Mon,) studied this question.