Phase III data presented for isavuconazole in Fungal Infection - Astellas

Astellas has reported efficacy and safety data for isavuconazole in the Phase III SECURE study for patients with invasive Fungal Infection. Previously announced topline data showed that the randomized, double-blind SECURE study met the primary objective of demonstrating non-inferiority of isavuconazole versus voriconazole for the primary treatment of invasive fungal disease caused by Aspergillus species or certain other filamentous fungi. The primary endpoint of 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.

Overall response (a composite of clinical, mycological and radiological responses) at end-of-therapy in the mITT population as assessed by the independent data review committee was 35.0% for isavuconazole versus 36.4% for the comparator voriconazole. Treatment emergent adverse events for isavuconazole were statistically fewer relative to voriconazole in the System Organ Classes of hepatobiliary (8.9% vs. 16.2%), skin (33.5% vs. 42.5%) and eye disorders (15.2% vs. 26.6%). Data were presented at the European Congress of Clinical Microbiology and Infectious Diseases.