New antifungal is as effective as existing drugs and with fewer adverse events
A newly developed antifungal, isavuconazole, is as effective against invasive mold disease in cancer patients as the existing drug, voriconazole. In addition, isavuconazole has fewer adverse effects. This data from a phase 3 clinical trial was presented at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy, an infectious disease meeting of the American Society for Microbiology, held in Washington, DC.
"There is a growing need for new antifungal therapies like isavuconazole because serious fungal infections caused by Aspergillus and other molds are on the rise due to the increasing numbers of immunosuppressed patients, including those with active cancer. These infections are associated with high morbidity and mortality. If approved, isavuconazole has the potential to be an important new option for the treatment of these life-threatening fungal infections," said presenter Andrew Ullman, MD, of Julius Maximilians University in Wuerzburg, Germany.
Invasive fungal infections are important causes of morbidity and death for patients with hematologic malignancies. Many leukemia and lymphoma patients receive high-dose chemotherapy, sometimes followed by stem cell transplantation, compromising their immune systems. The genus Aspergillus comprises several hundred species of mold that are ubiquitous in the environment but pose little threat to people with healthy immune systems. Immunocompromised patients, however, are more vulnerable to infection.
Ullman presented results from a large randomized phase 3 study comparing the efficacy and safety of isavuconazole, a newly developed antifungal, with the existing drug voriconazole. The trial was carried out in a subset of patients with uncontrolled cancer. The results showed that isavuconazole was as effective as voriconazole for treatment of invasive mold disease. In addition, isavuconazole had significantly fewer drug-related adverse events than voriconazole.
"In this study, isavuconazole had significantly fewer adverse events than voriconazole, particularly in the eye, skin, and hepatobiliary organ (liver, gall blabber, and bile duct) classes. These results show the potential of isavuconazole as a potent antifungal in the fight against invasive mold disease," said co-presenter Kieren Marr, MD, of Johns Hopkins University in Baltimore, Maryland.
Isavuconazole is an investigational once-daily intravenous and oral broad-spectrum antifungal being developed by Astellas and Basilea Pharmaceutica International Ltd. for the treatment of life-threatening invasive fungal infections. Recently Astellas submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for isavuconazole for the treatment of invasive aspergillosis and invasive mucomycosis (also known as zygomycosis).