Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis

Summary

The purpose of this study is to compare the efficacy and safety of isavuconazole versus voriconazole in the treatment of patients with invasive aspergillosis.

Timeline

Start

2007-03-07

Primary completion

2013-03-28

Completion

2013-03-28

Outcome

Met primary endpoint

paper Because the upper bound of the 95% CI (5·7%) did not exceed 10%, non-inferiority was shown. PMID 26684607 ↗

release “Isavuconazole phase 3 invasive aspergillosis study (SECURE) meets primary endpoint” basilea.com ↗

release “In the phase 3 invasive aspergillosis SECURE study, isavuconazole demonstrated non-inferiority to voriconazole on the primary endpoint of all-cause mortality at day 42.” basilea.com ↗

release “In the SECURE study (a study of 516 patients), isavuconazole demonstrated non-inferiority to voriconazole on the primary endpoint of all-cause mortality at Day 42” basilea.com ↗

release “In the SECURE study, isavuconazole was non-inferior to voriconazole based on the primary endpoint of all-cause mortality at Day 42 in the intent-to-treat population.” basilea.com ↗

Publications

• Hamed K, Engelhardt M, Kovanda LL, Huang JJ, Yan J, Aram JA. Post-hoc analysis of the safety and efficacy of isavuconazole in older patients with invasive fungal disease from the VITAL and SECURE studies. Sci Rep. 2023 Apr 25;13(1):6730. doi: 10.1038/s41598-023-31788-1.
• Kovanda LL, Kolamunnage-Dona R, Neely M, Maertens J, Lee M, Hope WW. Pharmacodynamics of Isavuconazole for Invasive Mold Disease: Role of Galactomannan for Real-Time Monitoring of Therapeutic Response. Clin Infect Dis. 2017 Jun 1;64(11):1557-1563. doi: 10.1093/cid/cix198.
• Maertens JA, Raad II, Marr KA, Patterson TF, Kontoyiannis DP, Cornely OA, Bow EJ, Rahav G, Neofytos D, Aoun M, Baddley JW, Giladi M, Heinz WJ, Herbrecht R, Hope W, Karthaus M, Lee DG, Lortholary O, Morrison VA, Oren I, Selleslag D, Shoham S, Thompson GR 3rd, Lee M, Maher RM, Schmitt-Hoffmann AH, Zeiher B, Ullmann AJ. Isavuconazole versus voriconazole for primary treatment of invasive mould disease caused by Aspergillus and other filamentous fungi (SECURE): a phase 3, randomised-controlled, non-inferiority trial. Lancet. 2016 Feb 20;387(10020):760-9. doi: 10.1016/S0140-6736(15)01159-9. Epub 2015 Dec 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Isavuconazole	Small molecule	200 mg	Intravenous
Comparator	Voriconazole	Small molecule	4 mg/kg	Intravenous
Comparator	Voriconazole	Small molecule	200 mg	Intravenous

Indications