Astellas announced that topline data from the pivotal Phase 3 trial, SECURE. This evaluated Cresemba (isavuconazonium sulfate) in adult patients with invasive aspergillosis. The results were published in The Lancet.
SECURE is a randomized, double-blind, multicenter, active-control Phase 3 study which evaluated Cresemba in 527 adult patients with invasive aspergillosis or other filamentous fungi. Patients received 372mg of isavuconazonium sulfate IV (equivalent to 200mg of isavuconazole) every three hours for the first 48 hours as a loading dose (LD). On Day 3, patients received 372mg of isavuconazonium sulfate IV or oral compared to voriconazole at 6mg/kg IV every 12 hours for the first 24 hours as LD, then 4mg/kg IV every 12 hours for the following 24 hours. This was followed by 200mg oral every 12 hours. The primary endpoint was non-inferiority of all-cause mortality through Day 42 in patients who received at least one dose of the study drug.
RELATED: Infectious Disease Resource Center
Results from the study showed that Cresemba is non-inferior to voriconazole on the primary endpoint of all-cause mortality through Day 42, 18.6% vs. 20.2% respectively (95% CI: –8.0, 5.9). Findings were previously presented at the 25th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in April 2015.
Cresemba is an azole antifungal indicated for the treatment of invasive aspergillosis and invasive mucormycosis in adults.