Nuvation Bio is to expand its pivotal Phase III SIGMA trial into Europe to evaluate the investigational, oral, brain-penetrant, selective mutant isocitrate dehydrogenase 1 (IDH1) inhibitor safusidenib in patients with IDH1-mutant glioma.
This trial will be expanded into six study sites in France, Germany, Italy, Spain, Sweden, and the UK.
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The new sites build on existing trial activity in Australia, Canada, China, Japan, and the US, where recruitment is either underway or preparing to launch.
The randomised, placebo-controlled study is evaluating safusidenib as maintenance therapy for patients with high-risk IDH1-mutant astrocytoma who have undergone standard-of-care radiotherapy or chemoradiotherapy alongside adjuvant temozolomide.
Progression-free survival, measured via blinded independent central review, serves as the primary endpoint. Around 300 participants are scheduled to take part in this main pivotal segment.
Alongside the core trial, an exploratory cohort plans to enrol nearly 40 chemotherapy- and radiotherapy-naïve participants with grade 3 IDH1-mutant oligodendroglioma to evaluate objective response rate.
Nuvation Bio founder, president and CEO David Hung said: “Our goal is to develop therapies that create a profound, positive impact on patients’ lives, and for safusidenib that means building a broad development programme that has the potential to reach more people with IDH1-mutant glioma in need of treatment options around the world.
“Expanding SIGMA to sites across six European countries is an important step for patients, and we have been encouraged by the strong interest in the study from physicians and the glioma community in Europe.
“We sincerely thank the investigators, site teams, patient advocates and patients who will help make this study possible.”
The US Food and Drug Administration (FDA) granted fast track designation to safusidenib in August 2026 for IDH1-mutant glioma treatment.
Safusidenib is also undergoing assessment in the Phase III G307 study in territories where vorasidenib lacks approval or availability, as well as in the Phase II G209 trial for individuals whose cancer progressed following vorasidenib therapy.
In March 2024, Nuvation Bio dosed the first subject in a Phase I/II clinical trial of NUV-1511, a new drug-drug conjugate (DDC) aimed at treating advanced solid tumours.
