Phase 3 trial results indicate a new antifungal medication olorofim is as effective as current standard treatments for invasive aspergillosis with fewer side effects.
RT’s Three Key Takeaways:
- Comparable efficacy demonstrated: The Phase 3 OASIS study found olorofim was as effective as the current standard of care for treating invasive aspergillosis, with nearly identical mortality rates at day 42.
- Improved safety profile: Patients receiving the investigational oral drug experienced significantly fewer drug-related adverse events compared to those on standard therapy, primarily due to a lower incidence of kidney-related issues.
- New treatment class: If approved by the Food and Drug Administration (FDA), this medication would be the first antifungal with a new mechanism of action for this condition in more than two decades.
F2G and Shionogi announced positive topline results from the Phase 3 OASIS study evaluating the investigational oral antifungal olorofim for the treatment of invasive aspergillosis, according to a news release. The study focused on patients whose infections were either resistant to or unsuitable for standard azole therapy.
The global trial met its primary endpoint of non-inferiority. The all-cause mortality rate at day 42 was 23.8% for olorofim compared to 24.3% for AmBisome followed by standard of care.
“The OASIS topline results add to the growing body of evidence supporting olorofim’s therapeutic potential in a hard-to-treat population with limited antifungal options,” said Johan Maertens, principal investigator. “We’re hopeful this could offer a meaningful alternative for clinicians to treat challenging infections caused by Aspergillus.”
Beyond efficacy, the study highlighted a difference in safety profiles between the two treatment arms. The rate of drug-related treatment-emergent adverse events was 35.8% for those taking olorofim, compared to 63.9% for those receiving the standard of care.
The difference in adverse events was mainly attributed to a higher rate of renal events in the AmBisome arm. In current healthcare practice, the impact of antifungal treatments on renal function often complicates treatment selection and continuation.
“In current clinical practice, safety and tolerability considerations, particularly effects on renal function, can pose significant challenges for treatment selection and continuation,” said John Keller, senior vice president of R&D at Shionogi. “Against this background, the results of the OASIS study suggest that olorofim has the potential to offer a new treatment option for patients with invasive aspergillosis.”
Invasive aspergillosis is a life-threatening fungal infection that primarily affects immunocompromised patients. It is associated with high rates of illness and death, and treatment options are currently limited for patients who cannot tolerate or do not respond to existing azole therapies.
Olorofim belongs to a new class of antifungals called orotomides. It features a novel mechanism of action and oral dosing, providing activity against various Aspergillus species, including those resistant to currently approved agents.
“These findings demonstrate the potential for olorofim to serve as a new option for patients with difficult to treat invasive fungal infections, including invasive aspergillosis,” said Francesco Maria Lavino, chief executive officer of F2G.
The medication has already received Breakthrough Therapy designations from the FDA. F2G and Shionogi plan to submit these Phase 3 data to regulatory authorities in the US, Europe, and Asia. Additional results from the study, including measures of clinical response, safety, and quality of life, will be presented at a future medical congress.
