824An Open-Label Phase 3 Study of Isavuconazole (VITAL): Focus on Mucormycosis

Abstract

Objective Isavuconazole is a novel, broad-spectrum triazole antifungal, available as a water-soluble prodrug in IV and oral formulations, for the treatment of invasive fungal disease (IFD). The objective of this analysis is to report the overall response, survival, and safety in a subset of patients with invasive mucormycosis (IM) who were treated with isavuconazole. Methods VITAL was a Phase III, multicenter, open-label trial conducted to evaluate safety and efficacy of isavuconazole treatment in patients with rare IFD. Eligibility criteria and evaluated outcomes are outlined in clinicaltrials.gov, NCT00634049. Patients received IV or PO isavuconazole 200 mg TID for 2 days followed by 200 mg day -1 until day 180, end of treatment (EOT). An independent data review committee (DRC) categorized patients as having proven or probable IFD by EORTC/MSG criteria. DRC-assessed overall response at EOT, survival, and adverse events (AEs) using standard definitions are reported for patients with proven/probable IM. Results Overall 37 patients with IM received isavuconazole for a median of 84 days (range 2-882). Baseline demographics, study outcomes, and survival are shown in Table 1. Survival at 180 days was 53%. Overall 95% of patients experienced an AE, 76% experienced a serious AE (SAE). Only 3 (8%) SAEs were attributed to isavuconazole. Conclusion Isavuconazole appears to be a safe and promising agent for the treatment of mucormycosis in a particularly high-risk immunocompromised population. (Table Presented).