P28 Rezafungin efficacy and safety in immunocompromised patients: sub-analyses of the Phase 3 trial in treatment of candidaemia and invasive candidiasis

Abstract Background Rezafungin (RZF) once weekly (QWk) is a next-generation echinocandin in development for treatment of candidaemia and invasive candidiasis (IC) prevention fungal disease caused by Candida, Aspergillus, Pneumocystis spp. BMT. Objectives The Phase 3 ReSTORE trial (NCT03667690) demonstrated RZF QWk noninferiority to caspofungin (CAS) QD. This sub-analysis evaluated efficacy safety outcomes patients identified as immunocompromised (immuno-c) during the trial. Methods As previously described, adults with confirmed and/or IC were randomized (400 mg Wk1 then 200 QWk) or CAS QD ≥14 days (≤4 weeks) optional oral fluconazole stepdown CAS. In this sub-analysis, immuno-c those prior concomitant use immunosuppressants (e.g. calcineurin inhibitors corticosteroids) medical history ongoing at screening neutropenia, BMT, SOT, lymphoma leukaemia. Results Of 187 (mITT population), 90 defined. are data available analyses: Day 14 global cure—Immuno-c: RZF, 51.1% (23/45); CAS, 55.6% (25/45); –No immuno-c: 66.7% (32/48); 65.3% (32/49). 5 mycological eradication—Immuno-c: 64.4% (29/45); no 72.9% (35/48); 71.4% (35/49). Among immuno-c, more had ≥1 AE (96.9%) SAE (64.6%) versus (79.0% 45.0% respectively). Conclusions ReSTORE, immune-c status reduced rates overall but did not change rate differences between