F2G and Shionogi said their experimental oral antifungal olorofim met the primary endpoint in the Phase 3 OASIS trial, showing non-inferiority to intravenous AmBisome followed by standard care in adults with invasive aspergillosis.
The global study randomized 225 patients whose infections had not responded to azole antifungals or who could not appropriately receive those treatments because of resistance, intolerance, drug interactions or breakthrough infection.
By Day 42, mortality was 23.8% among 151 patients assigned olorofim and 24.3% among 74 assigned AmBisome followed by standard care. The difference was minus 0.5 percentage points, meeting the trial’s prespecified non-inferiority margin of 20 percentage points.
The finding does not establish that olorofim is superior to the comparator.
At Day 84, mortality was 32.5% with olorofim and 29.7% with the comparator. Successful global responses, requiring clinical, radiological and mycological improvement, occurred in 30.5% and 28.4%, respectively.
Investigators attributed at least one adverse event to treatment in 35.8% of olorofim recipients, compared with 63.9% in the comparator safety group. Treatment-related kidney events occurred in 1.3% and 22.2%, respectively.
Drug-induced liver injury remains an important safety concern. Expert reviewers judged liver injury at least possibly treatment-related in 4.6% of olorofim recipients and 4.2% of comparator recipients.
Invasive aspergillosis is a potentially fatal fungal infection primarily affecting immunocompromised patients.
F2G expects to resubmit its U.S. approval application by year-end. Shionogi will submit data in Europe and Asia.
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