Astellas today announced topline results from the Phase 3 ACTIVE study evaluating the efficacy and safety of intravenous (IV) and oral isavuconazole, commercially known as CRESEMBA® (isavuconazonium sulfate), under development for adults with candidemia and other invasive Candida infections. Results from the study demonstrated that the trial did not meet its primary endpoint of non-inferiority in overall treatment response in isavuconazole-treated patients at the end of IV therapy compared to caspofungin. The key secondary endpoint of IV isavuconazole followed by either IV or oral isavuconazole versus IV caspofungin followed by either IV caspofungin or oral voriconazole was comparable between groups. The overall safety profile for isavuconazole was similar to caspofungin and consistent with safety data seen in the previously reported Phase 3 studies with isavuconazole.
"We had hoped for a different outcome, as this is a patient population that would benefit from additional treatment options. We look forward to understanding these data following further analysis," said Bernie Zeiher, M.D., president, Global Development at Astellas. "CRESEMBA remains an important treatment option for the approved indications of invasive aspergillosis and invasive mucormycosis in the United States."
The overall response at the end of IV in the modified intent-to-treat population (N=400) was 60.3 percent in the isavuconazole treatment group and 71.1 percent in the caspofungin group with an adjusted treatment difference of -10.8 percent (95 percent CI; -19.9 percent, -1.8 percent). The lower bound of the 95 percent confidence interval of the treatment difference between isavuconazole and caspofungin exceeded the pre-specified non-inferiority margin of -15 percent.
CRESEMBA is approved in the United States to treat invasive aspergillosis and invasive mucormycosis in adults and is being co-developed with Basilea Pharmaceutica International Ltd.