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Cresemba comparable to voriconazole for invasive mold disease
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Recently published results from the SECURE trial suggest treatment of invasive mold disease with Cresemba is noninferior to treatment with voriconazole and may result in fewer adverse events.
“Voriconazole is the current gold standard for treatment of invasive aspergillosis but is limited by drug-drug interactions and safety concerns,” Dimitrios Kontoyiannis, MD, of the division of internal medicine at the University of Texas MD Anderson Cancer Center in Houston, and colleagues wrote. “Moreover, many non-Aspergillus molds, such as the agents of mucormycosis, are often resistant to voriconazole. This trial offers strong evidence that [Cresemba (isavuconazonium sulfate, Astellas Pharma)] is an appropriate alternative to voriconazole for the primary treatment of invasive aspergillosis and other mold disease.”
Dimitrios Kontoyiannis
In the phase 3 double blind trial, researchers randomly assigned 527 adult patients with suspected invasive mold disease a regimen of isavuconazole or voriconazole. From January 2007 to December 2008 and March 2011 to December 2013, participants were recruited from 102 centers in 26 countries and stratified by region, allogeneic hemopoietic stem cell transplantation and active malignant disease. Treatments lasted a maximum of 84 days, and researchers conducted clinical assessments at baseline, center visits, the end of treatment and 4 weeks after treatment. The primary efficacy endpoint was all-cause mortality from initiation to day 42, and other outcomes including overall response, safety, tolerability and all-cause mortality at various time periods.
The researchers reported treatment completion by 118 patients assigned isavuconazole and by 120 assigned voriconazole. Day 42 all-cause mortality was 19% and 20% among patients taking isavuconazole and voriconazole, respectively, leading the researchers to declare the study drug noninferior (adjusted treatment difference, –1%; 95% CI, –7.8 to 5.7). Nearly all patients in both groups experienced treatment-emergent adverse events, the most common being gastrointestinal disorders and infection, but fewer drug-related adverse events were reported in patients receiving the study drug (42% vs. 60%; P < .001). In addition, patients receiving isavuconazole less often experienced hepatobiliary disorders (P = .016), eye disorders (P = .002) and skin or subcutaneous tissue disorders (P = .037).
“Our study demonstrates that isavuconazole is noninferior to voriconazole in patients suspected of having invasive mold disease, but showed significantly fewer drug-related adverse events and fewer drug discontinuations,” the researchers wrote. – by Dave Muoio
Disclosure: Maertens reports relationships with Astellas Pharma, Basilea, Bio-Rad, Dohme, Gilead Sciences, Merck Sharp and Pfizer. Kontoyiannis reports associations with companies including Astellas, Merck and Pfizer. Please see the full study for a list of all other authors’ relevant financial disclosures.
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