The precise positioning of the emerging group of pharmacological inhibitors of mutant IDH enzymes remains to be refined by further studies and defined in national and international guidelines. The present study shall help to close this important knowledge gap when trying to define the role of mutant IDH inhibitors in the treatment algorithms for patients with IDH-mutant WHO grade 3 gliomas.
Safusidenib is a novel, oral, potent, brain penetrant inhibitor of mutant IDH1. It has shown high blood brain barrier penetration in both pre-clinical and clinical studies and demonstrated anti-tumor activity with complete or partial responses.
We aim at demonstrating the efficacy of safusidenib in patients with newly diagnosed IDH1-mutant CNS WHO grade 3 oligodendroglioma and astrocytoma, measured by progression-free survival at12 months.
Male or female, age ≥18 years.
Newly diagnosed and histologically confirmed IDH1-mutant WHO grade 3 glioma, without or with residual disease: astrocytoma IDH1-mutant, or oligodendroglioma, IDH1-mutant and 1p/19q-codeleted, CNS WHO grade 3. IDH1 mutation can be defined by immunohistochemistry or by sequencing. Any location in the central nervous system is permitted.
Karnofsky performance status of 70 or more.
Adequate hematologic and organ functions.
Inability to undergo brain or spine MRI.
Intent to be treated with radiotherapy or alkylating agent chemotherapy.
Any investigational antitumor therapy other than those under investigation in this study.
Any severe concomitant condition including active and uncontrolled infections or other severe concurrent disease, which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol, in the opinion of the investigator.
Single group
Safusidenib
DrugAll participants will receive safusidenib (250 mg BID) until progression or unacceptable toxicity.
progression-free survival at12 months
progression-free survival at 12 months measured by central review of MRI
Objective response to treatment in patients with measurable disease
MRI overall objective response measured centrally per RANO 2.0 criteria
Progression-free survival at 24 months
Progression-free survival at 24 months measured centrally per RANO 2.0 criteria
Median progression-free survival
Median progression-free survival measured centrally per RANO 2.0 criteria
Safety
Safety measured by CTCAE V6.0
Volumetric response
Response assessment using volumetric assessment
Response of 2-hydroxyglutarate levels by MR spectroscopy
2\. Reduction of 2-hydroxyglutarate levels by MR spectroscopy per local and central review
Response to treatment assessed by positron emission tomography (PET)
Response to treatment using amino acid PET assessed locally per local SOP and centrally per RANO 1.0
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University of Zurich
Lead sponsor
Nuvation Bio Inc.
Collaborator
University Hospital, Zürich
Collaborator
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