Phase III VITAL trial of Cresemba (isavuconazonium sulfate) in invasive mucormycosis published in The Lancet Infectious Diseases- Astellas

Astellas announced that results from the Phase III VITAL trial evaluating Cresemba (isavuconazonium sulfate) in adult patients with invasive mucormycosis were published in The Lancet Infectious Diseases. VITAL is the study from which a sub-group of patients supported the registration for the invasive mucormycosis indication for Cresemba. Thirty-seven mucormycosis patients received Cresemba (21 patients for primary therapy, 11 for refractory disease, and five after intolerance to other antifungals). Day 42 all-cause mortality was 38% whilst all all-cause mortality was 43% by Day 84. These results provide evidence that Cresemba is effective for the treatment for mucormycosis, in light of the natural history of untreated mucormycosis.

The efficacy of Cresemba for the treatment for invasive mucormycosis, however, has not been evaluated in concurrent, controlled clinical trials. Thirty-five of 37 (95%) patients experienced at least one adverse event (AE) during treatment and 28 patients had serious AEs. The most common AEs reported (>10% of patients) were vomiting (32%), diarrhea (27%), nausea (27%), pyrexia (37%), constipation (22%), decreased appetite (16%), headache (16%), peripheral oedema (16%), abdominal pain (14%), dyspnoea (14%), pneumonia (14%), back pain (11%), cough (11%), hypoglycaemia (11%), insomnia (11%) and restlessness (11%).