Positive new findings for Astellas' isavuconazole in mucormycosis

Japanese drug major Astellas Pharma (TYO: 4503) says that isavuconazole demonstrated successful outcomes in the treatment of mucormycosis (also known as zygomycosis), according to data from the Phase III isavuconazole VITAL study being presented at IDWeek* in Philadelphia.

The data assessed the efficacy and safety of isavuconazole in the treatment of patients with invasive mucormycosis (n=37) enrolled in the open-label, multicenter VITAL trial. Overall response at end of treatment, based on clinical, mycological and radiological criteria was assessed by an independent data review committee. Successful overall response at the end of isavuconazole treatment was observed in 31.4% of patients. The overall mortality rate was 37.8% and 43.2% through Day 42 and 84, respectively. Further, more than half (54.5%) of patients refractory (n=11) to prior antifungal therapy were alive through Day 84.

No new safety issues related to isavuconazole were identified in the study population. Treatment-emergent adverse events (TEAEs) and study drug-related TEAEs were reported in 35 (94.6%) and 13 (35.1%) patients with invasive mucormycosis, respectively. The most common TEAE occurring in patients treated with isavuconazole was vomiting (32.4%); diarrhea, nausea and pyrexia were equally the next most common TEAEs (27.0% for each). Three (8.1%) patients were reported by the investigator to have study drug-related serious AEs.