Phase III SECURE trial on Cresemba (isavuconazonium sulfate) in invasive aspergillosis published in The Lancet- Astellas

Astellas has announced that results from the pivotal Phase III SECURE trial evaluating Cresemba (isavuconazonium sulfate) in adult patients with invasive aspergillosis were published in The Lancet. The primary endpoint of the trial was non-inferiority of all-cause mortality through Day 42 in patients who received at least one dose of the study drug. Cresemba demonstrated non-inferiority to voriconazole on the primary endpoint of all-cause mortality through Day 42 in patients with proven, probable or possible invasive fungal disease. All-cause mortality through Day 42 in the intent-to-treat population was 18.6 percent in the Cresemba treatment group and 20.2 percent in the voriconazole treatment group. Topline data were previously presented at the 2015 European Congress of Clinical Microbiology and Infectious Diseases.

Comment: The FDA has approved the use of Cresemba for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis. In addition, the EMA has approved Cresemba for the treatment of adult patients with invasive aspergillosis and adult patients with mucormycosis for whom amphotericin B is inappropriate.