870. Olorofim for the treatment of invasive mould infections in patients with limited or no treatment options: Comparison of interim results from a Phase 2B open-label study with outcomes in historical control populations (NCT03583164, FORMULA-OLS, Study 32)

Maertens, Johan; Verweij, Paul E.; Lanuza, Evan F; Dane, Aaron; Zinzi, Daniela; Rex, John H.; Chen, Sharon Chia-Ju

doi:10.1093/ofid/ofac492.063

Cited by 11 publications

(6 citation statements)

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“…Recently published guidelines on the management of rare mould infections support first‐line voriconazole‐based combination therapy, particularly voriconazole plus terbinafine 16,17 . Results from the FORMULA‐OLS (evaluate F901318 treatment of invasive fungal infections in patients lacking treatment options) trial (http://clinicaltrials.gov, NCT03583164), which examined the efficacy of olorofim in patients with invasive mould infection and limited treatment options, demonstrated a 53% and 55% complete response rate in patients with L. prolificans and Scedosporium species respectively 18 …”

Section: Discussionmentioning

confidence: 99%

“…16,17 Results from the FORMULA-OLS (evaluate F901318 treatment of invasive fungal infections in patients lacking treatment options) trial (ClinicalTrials.gov, NCT03583164), which examined the efficacy of olorofim in patients with invasive mould infection and limited treatment options, demonstrated a 53% and 55% complete response rate in patients with L. prolificans and Scedosporium species respectively. 18 Detecting mould species in the blood using conventional microbiological techniques can be difficult. Growth and detection of filamentous fungi in the BacT/ Alert blood culture system is poor and may miss important fungi.…”

Section: Discussionmentioning

confidence: 99%

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Scedosporium species and Lomentospora prolificans fungaemia is uniformly fatal in patients with haematological malignancy

Stewart,

Heney,

Paterson

et al. 2023

Internal Medicine Journal

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Scedosporium and Lomentospora species are environmental moulds that are virulent in immunocompromised hosts and rarely cause bloodstream infection (BSI). Patients with Scedosporium and Lomentospora species BSI were identified by the state public laboratory service in Queensland, Australia, over a 20‐year period. Twenty‐two incident episodes occurred among 21 residents; one patient had a second episode 321 days following the first. Of these, 18 were Lomentospora prolificans, three were Scedosporium apiospermum complex and one was a nonspeciated Scedosporium species. Seventeen (81%) patients died during their index admission, and all‐cause mortality at 30, 90 and 365 days was 73%, 82% and 91% respectively. All 20 patients with haematological malignancy died within 365 days of follow‐up with a median time to death of 9 days (interquartile range, 6–20 days) following diagnoses of BSI.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Scedosporium species and Lomentospora prolificans fungaemia is uniformly fatal in patients with haematological malignancy

Stewart,

Heney,

Paterson

et al. 2023

Internal Medicine Journal

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“…Antifungal agents with a profile better suited for prophylaxis are needed. New antifungal drugs are being developed and tested, including promising candidates like the first-in-class olorofim [47,48], the novel triazole opelconazole optimized for inhalation [45], and amphotericin B delivered by alternative methods [49].…”

Section: Discussionmentioning

confidence: 99%

Invasive Aspergillosis among Lung Transplant Recipients during Time Periods with Universal and Targeted Antifungal Prophylaxis—A Nationwide Cohort Study

Crone,

Wulff,

Ledergerber

et al. 2023

JoF

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The optimal prevention strategy for invasive aspergillosis (IA) in lung transplant recipients (LTXr) is unknown. In 2016, the Danish guidelines were changed from universal to targeted IA prophylaxis. Previously, we found higher rates of adverse events in the universal prophylaxis period. In a Danish nationwide study including LTXr, for 2010–2019, we compared IA rates in time periods with universal vs. targeted prophylaxis and during person-time with vs. person-time without antifungal prophylaxis. IA hazard rates were analyzed in multivariable Cox models with adjustment for time after LTX. Among 295 LTXr, antifungal prophylaxis was initiated in 183/193 and 6/102 during the universal and targeted period, respectively. During the universal period, 62% discontinued prophylaxis prematurely. The median time on prophylaxis was 37 days (IQR 11–84). IA was diagnosed in 27/193 (14%) vs. 15/102 (15%) LTXr in the universal vs. targeted period, with an adjusted hazard ratio (aHR) of 0.94 (95% CI 0.49–1.82). The aHR of IA during person-time with vs. person-time without antifungal prophylaxis was 0.36 (95% CI 0.12–1.02). No difference in IA was found during periods with universal vs. targeted prophylaxis. Prophylaxis was protective of IA when taken. Targeted prophylaxis may be preferred over universal due to comparable IA rates and lower rates of adverse events.

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“…It selectively inhibits fungal dihydroorortate dehydrogenase, a key enzyme in fungal pyrimidine biosynthesis. With action against aspergillus, moulds and dimorphic fungi its use has been reported in a number of case reports and case series in lung transplant recipients 132 . Given its tolerability and lower incidence of side effects, it may be better suited to prophylaxis than some of the currently available drugs though higher level evidence is required.…”

Section: Management Of Infectionmentioning

confidence: 99%

Advances in lung transplantation: 60 years on

Paraskeva,

Snell

2024

Respirology

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Lung transplantation is a well‐established treatment for advanced lung disease, improving survival and quality of life. Over the last 60 years all aspects of lung transplantation have evolved significantly and exponential growth in transplant volume. This has been particularly evident over the last decade with a substantial increase in lung transplant numbers as a result of innovations in donor utilization procurement, including the use donation after circulatory death and ex‐vivo lung perfusion organs. Donor lungs have proved to be surprisingly robust, and therefore the donor pool is actually larger than previously thought. Parallel to this, lung transplant outcomes have continued to improve with improved acute management as well as microbiological and immunological insights and innovations. The management of lung transplant recipients continues to be complex and heavily dependent on a tertiary care multidisciplinary paradigm. Whilst long term outcomes continue to be limited by chronic lung allograft dysfunction improvements in diagnostics, mechanistic understanding and evolutions in treatment paradigms have all contributed to a median survival that in some centres approaches 10 years. As ongoing studies build on developing novel approaches to diagnosis and treatment of transplant complications and improvements in donor utilization more individuals will have the opportunity to benefit from lung transplantation. As has always been the case, early referral for transplant consideration is important to achieve best results.

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870. Olorofim for the treatment of invasive mould infections in patients with limited or no treatment options: Comparison of interim results from a Phase 2B open-label study with outcomes in historical control populations (NCT03583164, FORMULA-OLS, Study 32)

Cited by 11 publications

References 0 publications

Scedosporium species and Lomentospora prolificans fungaemia is uniformly fatal in patients with haematological malignancy

Scedosporium species and Lomentospora prolificans fungaemia is uniformly fatal in patients with haematological malignancy

Invasive Aspergillosis among Lung Transplant Recipients during Time Periods with Universal and Targeted Antifungal Prophylaxis—A Nationwide Cohort Study

Advances in lung transplantation: 60 years on

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