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Isavuconazole noninferior for invasive mold disease in hematologic malignancies

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WASHINGTON, D.C. — In a subset of patients with hematologic malignancies, isavuconazole was noninferior to voriconazole in treating invasive mold disease, researchers reported here at ICAAC 2014.

“The caveat is that in the modified intent-to-treat analysis, there were only about 100 patients who received the drug,” Kieran Marr, MD, director of transplant and oncology infectious diseases and professor of medicine at Johns Hopkins University, told Infectious Disease News. “Although officially, the conclusion is that it demonstrated noninferiority, that conclusion is not definitive because the study was not powered to determine noninferiority in this subgroup.”

 

Kieran Marr

This outcome analysis was a substudy of the SECURE study in which isavuconazole (Astellas) was evaluated for noninferiority against voriconazole for the treatment of invasive mold disease, including invasive aspergillosis. The FDA designated isavuconazole as an orphan drug under the Generating Antibiotic Incentives Now (GAIN) Act last year, and it accepted a new drug application from Astellas in the past week.

This substudy included 433 patients with underlying hematologic malignancies and possible, probable or proven invasive mold disease. The modified intent-to-treat analysis included only patients with probable or proven disease. Among the 217 patients, 112 were assigned to isavuconazole and 105 were assigned to voriconazole.

There was no difference in all-cause mortality between the two groups at week 6, which was the primary endpoint. There was also no difference at week 12, which was the secondary endpoint. There were also significantly fewer adverse effects associated with isavuconazole. However, Marr said patients who receive voriconazole also typically undergo therapeutic drug monitoring because of the significant toxicities associated with the drug.

“There was no therapeutic drug monitoring within this trial because it is discouraged for a registrational trial,” Marr said. “One could make the argument that if these drugs were tested head-to-head, there would be more adverse effects in the voriconazole arm. But whether or not you can modulate those events by following levels is the real-life question that will come up in practice.” — by Emily Shafer

For more information:

Marr K. Abstract M-1757. Presented at: Interscience Conference on Antimicrobial Agents and Chemotherapy; Sept. 5-9, 2014; Washington, D.C.

Disclosure: Marr is a consultant for Astellas, Merck and Pfizer. Other researchers report relationships with Amgen, Astellas, AstraZeneca, Gilead, GlyPharma, Janssen, Merck Sharp & Dohme, Pfizer and TEVA.