Results Announced for Isavuconazole in Antifungal Study
Astellas announced safety and efficacy results from its Phase 3 SECURE trial with isavuconazole for the treatment of invasive asperigillosis. Isavuconazole is an investigational once-daily intravenous and oral broad-spectrum antifungal.
SECURE is a randomized, double-blind trial, investigating the use of isavuconazole vs. voriconazole for the primary treatment of invasive fungal disease caused by Aspergillus species or certain other filamentous fungi. The study met the primary endpoint of demonstrating non-inferiority of isavuconazole vs. voriconazole.
All-cause mortality through Day 42 in the intent-to-treat population (ITT, N=516) was 18.6% in the isavuconazole (ISA) treatment group and 20.2% in the voriconazole (VRC) group. The upper limit of the 95% confidence interval of the adjusted treatment group difference was 5.7%, which is below the pre-specified 10% non-inferiority margin. All-cause mortality through day 42 in patients with proven/probable invasive fungal disease (modified intent-to-treat, mITT population) was 19.6% (ISA) and 23.3% (VRC). Overall response (a composite of clinical, mycological and radiological responses) at end-of-therapy in the mITT population committee was 35.0% for isavuconazole vs. 36.4% for the comparator voriconazole.
Previously, the FDA has granted Fast Track status, QDIP, and Orphan Drug designation to isavuconazole for invasive aspergillosis and mucomycosis.
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