Shionogi and F2G are releasing further data from a non-inferiority study of the latter’s oral invasive aspergillosis drug, showing its promise in longer-term mortality.
In the Phase III OASIS trial (NCT05101187) evaluating oral olorofim for the fungal infection, similar efficacy was seen across secondary endpoints, as was achieved in the primary endpoint of non-inferiority in all-cause mortality (ACM). In the study, oral olorofim was compared to AmBisome (liposomal amphotericin B for injection), followed by standard of care (SoC).
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The Mycoses Study Group – European Organization for Research and Treatment of Cancer (MSG-EORTC) global response was 26.5% compared to 31.1% at day 42 and 30.5% versus 28.4% at day 84 for olorofim versus AmBisome plus SoC, respectively.
In previously reported primary endpoint data, ACM at day 42 was 23.8% compared to 24.3% in the two arms, respectively, proving non-inferiority. The rate of ACM at day 84 for olorofim was 32.5% vs. 29.7% for the comparator arm.
Successful global response requires improvement of all three of its clinical, radiological and mycological subcomponents.
The number of patients with at least one drug-related adverse event (AE) was 35.8% for olorofim and 63.9% for AmBisome plus SoC, with fewer renal AEs in the olorofim cohort. Drug-induced liver injury (DILI) remains an important safety signal for antifungal agents and remained similar in both arms.
Additionally, patients treated with olorofim were discharged from the hospital earlier. The study enrolled 225 adult patients with invasive aspergillosis whose infection is either refractory to or inappropriate for azole therapy.
These new data will be featured in a late-breaking oral presentation at IDWeek 2026 on 22 October 2026. It will also be presented to the US Food and Drug Administration (FDA), as well as the European Medicines Agency (EMA) and regulatory bodies in Asia.
The FDA previously issued a complete response letter regarding a new drug application (NDA) for olorofim in June 2023, stating that it was not able to approve olorofim at the time and requested additional data and analyses.
Invasive aspergillosis is a life-threatening fungal infection that primarily affects immunocompromised patients and is associated with substantial morbidity and mortality. Treatment options are limited for patients who cannot be treated with available azole antifungal therapies.
Dr Johan Maertens, professor of haematology at University Hospitals Leuven, Belgium, and the study’s principal investigator, said: “Having an oral option like olorofim, with data supporting its safety in challenging patients, including those with complex drug interactions, would give me another valuable tool in the fight against this fungal infection.”
Shionogi and F2G signed a collaboration agreement to develop and commercialise olorofim in May 2022. As per the agreement, Shionogi has commercial responsibility for olorofim in Europe and Asia, while F2G has commercial responsibility in North America and other territories outside Shionogi’s regions.
In invasive pulmonary aspergillosis specifically, Pulmocide recently terminated a Phase III trial of its inhaled respiratory drug after detecting a higher mortality rate in the treatment group. The Phase III Opera-T trial (NCT05238116) was evaluating opelconazole in refractory invasive pulmonary aspergillosis (IPA).
Pulmonary aspergillosis is a term used to describe various types of lung infections caused by the fungus Aspergillus. These infections can range from mild to severe and can affect patients with compromised immune systems, such as those undergoing treatment for haematologic cancers or organ transplantation.
Current treatment options include oral steroids, which are commonly used to treat allergic bronchopulmonary aspergillosis (ABPA), or oral antifungals, which are used to treat both ABPA and other forms of pulmonary aspergillosis.
