P27 Rezafungin treatment of candidaemia and invasive candidiasis: outcomes stratified by baseline renal function—analysis of the Phase 2 + Phase 3 trials

Abstract

Abstract Background Rezafungin (RZF) once weekly (QWk) is a next-generation echinocandin in development for treatment of candidaemia and invasive candidiasis (IC) and prevention of invasive fungal disease caused by Candida, Aspergillus, and Pneumocystis spp. in BMT. RZF QWk was compared with caspofungin (CAS) QD in two double-blind, randomized, controlled trials of treatment of candidaemia and/or IC: STRIVE (Phase 2, NCT02734862) and ReSTORE (NCT03667690). Objectives Trial data (Phase 2 + Phase 3) were analysed to evaluate outcomes stratified by renal function at baseline: CrCl ≥ 60 mL/min (normal/mild impairment [Norm/Mild]) and <60 mL/min (moderate/severe impairment [Mod/Sev]). Methods Outcomes were evaluated for differences between CrCl categories and between treatment groups: RZF QWk 400 mg on Wk 1 then 200 mg versus CAS QD 70 mg on Day (D)1 then 50 mg, for ≥14 days (≤4 Wks) w/optional oral fluconazole stepdown for CAS. Results D30 all-cause mortality (ACM)—Mod/Sev: RZF, 13% (7/54); CAS, 30.5% (18/59); Norm/Mild: RZF, 22.7% (17/75); CAS, 10.8% (9/83). Mycological eradication (ME) at D5—Mod/Sev: RZF, 75.9% (41/54); CAS, 61.0% (36/59); Norm/Mild: RZF, 74.7% (56/75); CAS, 66.3% (55/83). ME at D14—Mod/Sev: RZF, 75.9% (41/54); CAS, 57.6% (34/59); Norm/Mild: RZF, 69.3% (52/75); CAS, 74.7% (62/83). ≥1 treatment-emergent AE—Mod/Sev: RZF, 93.2% (55/59); CAS, 88.9% (56/63); Norm/Mild: RZF, 88.9% (72/81); CAS, 76.7% (69/90). Conclusions RZF efficacy was comparable across CrCl categories, with higher ME and lower D30 ACM in the Mod/Sev group. Further analyses are needed to evaluate the observed differences between treatment groups.