CRESEMBA^® (isavuconazole) is indicated for mucormycosis in patients for whom amphotericin B is inappropriate.¹

VITAL was a single-arm, open-label trial which assessed the efficacy and safety of CRESEMBA^® for the treatment of mucormycosis and compared its efficacy with amphotericin B in a matched case-control analysis.²

• Primary disease group (defined as ≤4 days of previous systemic antifungals; n=21) were matched with controls from the FungiScope Registry who received primary AmB-based treatment

Primary endpoints

• Overall response at day 42 as determined by an independent data review committee. Overall responses were classified as complete or partial (deemed treatment success); or stable or progressive disease (deemed treatment failure) according to prespecified criteria.

Secondary endpoints

• Overall, clinical, radiological and mycological responses at day 42 (n=37), day 84 and end of treatment
• All-cause (crude and weighted) mortality at days 42 and 84
• Matched case-control analysis using the FungiScope: Global Emerging Fungal Infection Registry for day 42 crude all-cause mortality

Primary efficacy endpoint, DRC-assessed overall response at day 42 (n=37), demonstrated:

• Partial response: 11% 
• Stable mucormycosis: 43%
• Disease progression: 3% 
• Missing data: 8% 
• Death: 35%

In the case-control analysis (patients with mucormycosis from VITAL matched with controls from the FungiScope registry) survival was similar with CRESEMBA^® and amphotericin B.^2,b

• Weighted all-cause mortality (day 42): 33% vs 41% (p=0.595)

The AE profile of CRESEMBA^® in VITAL was consistent with observations from the SECURE trial (invasive aspergillosis).²

The survival rates and safety profile of CRESEMBA^® allow you to prescribe with confidence for your patients with mucormycosis, for whom amphotericin B is inappropriate^1,2

a. Oral or intravenous loading regimen determined at the discretion of local investigators.
b. Patients were censored on the day of their last known survival status (circles).

AE, adverse events; AmB, amphotericin B; CI, confidence interval; DRC, data review committee; HR, hazard ratio; IV, intravenous; PO, orally; q8h, every 8 hours; q24h, every 24 hours; TEAE, treatment-emergent adverse events.

Prescribing Information:

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