Isavuconazole has shown non-inferiority versus Voriconazole for the primary treatment of invasive fungal disease caused by Aspergillus species or certain other filamentous fungi
Astellas Pharma has announced positive topline data from the Isavuconazole phase 3 invasive aspergillosis study. The randomized, double-blind Isavuconazole study ( SECURE ) has achieved its primary objective in demonstrating non-inferiority versus Voriconazole ( Vfend ) for the primary treatment of invasive fungal disease caused by Aspergillus species or certain other filamentous fungi.
Isavuconazole was effective as determined by the primary endpoint of all-cause mortality through day 42 in the intent-to-treat population ( n=516 ).
The all-cause-mortality was 18.6% in the Isavuconazole treatment group and 20.2% in the Voriconazole group.
The 95% confidence interval of the treatment difference between Isavuconazole and Voriconazole was within the pre-specified non-inferiority margin of 10%.
In addition, the key secondary endpoint of overall success rate ( composite of clinical, mycological, radiological responses ) at the end-of-therapy in patients with proven/probable disease was similar between Isavuconazole and Voriconazole ( 35.0% and 36.4%, respectively ). This outcome was based on a blinded assessment by the Independent Data Review Committee.
Overall, drug- and non-drug-related adverse events were reported in 96.1% and 98.5% of patients in the Isavuconazole and Voriconazole treatment groups, respectively.
The most frequent adverse events reported were nausea, vomiting, pyrexia ( fever ), diarrhea, and hypokalaemia ( deficiency of potassium in the blood ), which were reported at similar rates in both treatment groups.
Study drug-related adverse events were reported in 42.4% and 59.8% of patients in the Isavuconazole and Voriconazole treatment groups, respectively.
Invasive aspergillosis is estimated to occur in 5-13% of recipients of bone marrow transplants, 5-25% of patients who have received heart or lung transplants, and 10-20% of patients who are receiving intensive chemotherapy for leukemia.
Mortality rates for transplant patients with invasive aspergillosis have been reported to be between 34% and 58%.
Around 47% of solid organ transplant recipients who developed invasive aspergillosis had renal insufficiency and acute renal failure was reported for 43% of intensive care unit ( ICU ) patients with invasive aspergillosis, compared to 20.5% in the general ICU population. ( Xagena )
Source: Astellas, 2013
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