Mycoses · 2026
Rezafungin Versus Caspofungin in Candidaemia and Invasive Candidiasis: A Post Hoc Pooled Analysis of Phase 2 and Phase 3 Trials.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыКлиническое исследование II фазыСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Soriano Alex, Thompson George R, Cornely Oliver A, Bassetti Matteo, Kullberg Bart Jan, Honoré Patrick M, Dupont Hervé, Vazquez Jose A, Huang Haihui, Zhang Yingyuan, Dickerson Sara, Cox Laura, Pappas Peter G
Аннотация
BACKGROUND: The efficacy and safety of rezafungin in invasive candidiasis (IC) and candidaemia was demonstrated in the Phase 2 STRIVE and Phase 3 ReSTORE trials, and an additional cohort of patients in ReSTORE from China (ReSTORE China).
OBJECTIVES: This post hoc analysis is the first time that combined data from all double-blind, randomised Phase 2 and 3 rezafungin trials have been evaluated. Outcomes were comprehensively assessed across a large, diverse population.
METHODS: Data were assessed from adults with candidaemia/IC in STRIVE (NCT02734862) and ReSTORE (NCT03667690) (including the China extension cohort) who received weekly rezafungin 400/200 mg or daily caspofungin 70/50 mg for ≤ 4 weeks. Efficacy was assessed in the modified intent-to-treat population. Endpoints were Day 30 all-cause mortality (ACM, primary), mycological response at Days 5 and 14 (secondary) and time to negative blood cultures (TTNBC, secondary). Treatment-emergent adverse events were assessed in the safety population.
RESULTS: Overall, 372 patients were included (rezafungin 179; caspofungin 193). Day-30 ACM was 20% (33/161) for rezafungin versus 22% (39/178) for caspofungin (weighted difference, -2.4% [95% confidence interval -11.2 to 6.4]). Day-5 and Day-14 mycological eradication rates were 73% and 70% for rezafungin versus 65% and 68% for caspofungin, respectively. Median TTNBC was shorter for rezafungin than for caspofungin (23.1 versus 36.7 h, respectively; p = 0.0073). Adverse-event profiles were generally similar across treatments.
CONCLUSIONS: This pooled analysis of Phase 2 and Phase 3 data, including the China extension cohort, supports the efficacy and safety of rezafungin. Rezafungin was non-inferior to caspofungin, with earlier mycological eradication.
OBJECTIVES: This post hoc analysis is the first time that combined data from all double-blind, randomised Phase 2 and 3 rezafungin trials have been evaluated. Outcomes were comprehensively assessed across a large, diverse population.
METHODS: Data were assessed from adults with candidaemia/IC in STRIVE (NCT02734862) and ReSTORE (NCT03667690) (including the China extension cohort) who received weekly rezafungin 400/200 mg or daily caspofungin 70/50 mg for ≤ 4 weeks. Efficacy was assessed in the modified intent-to-treat population. Endpoints were Day 30 all-cause mortality (ACM, primary), mycological response at Days 5 and 14 (secondary) and time to negative blood cultures (TTNBC, secondary). Treatment-emergent adverse events were assessed in the safety population.
RESULTS: Overall, 372 patients were included (rezafungin 179; caspofungin 193). Day-30 ACM was 20% (33/161) for rezafungin versus 22% (39/178) for caspofungin (weighted difference, -2.4% [95% confidence interval -11.2 to 6.4]). Day-5 and Day-14 mycological eradication rates were 73% and 70% for rezafungin versus 65% and 68% for caspofungin, respectively. Median TTNBC was shorter for rezafungin than for caspofungin (23.1 versus 36.7 h, respectively; p = 0.0073). Adverse-event profiles were generally similar across treatments.
CONCLUSIONS: This pooled analysis of Phase 2 and Phase 3 data, including the China extension cohort, supports the efficacy and safety of rezafungin. Rezafungin was non-inferior to caspofungin, with earlier mycological eradication.