Nuvation Bio plans to bring its late-stage SIGMA study to six European countries, widening access to an experimental brain cancer therapy for patients who have exhausted standard options.
The Phase III trial tests safusidenib, an oral drug engineered to cross the blood-brain barrier and selectively block mutant IDH1 enzymes. That mechanism targets a genetic driver present in many gliomas, a notoriously difficult-to-treat class of brain tumors.
Sites in France, Germany, Italy, Spain, Sweden, and the United Kingdom will now join existing locations across Australia, Canada, China, Japan, and the United States. Some of those regions have already begun screening patients, while others prepare to open enrollment.
The randomized, placebo-controlled study focuses on high-risk IDH1-mutant astrocytoma. Participants must have completed standard radiotherapy or chemoradiotherapy with adjuvant temozolomide before entering the maintenance phase. Blinded independent central review will measure progression-free survival as the primary endpoint. Roughly 300 patients will enroll in this pivotal segment.
Meanwhile, a separate exploratory cohort will assess objective response rates in nearly 40 participants with grade 3 IDH1-mutant oligodendroglioma who have not yet received chemotherapy or radiation.
David Hung, founder, president, and CEO of Nuvation Bio, pointed to strong physician interest across Europe as a driving factor. He credited investigators, site teams, advocates, and patients for making the expansion feasible.
Regulatory momentum supports the effort. The US Food and Drug Administration awarded fast track designation to safusidenib in August 2026 for IDH1-mutant glioma. The drug also faces evaluation in the Phase III G307 study, which covers regions where vorasidenib remains unapproved or unavailable. A separate Phase II G209 trial targets patients whose disease progressed after vorasidenib treatment.
As Nuvation Bio pushes into European markets, the company continues parallel work on NUV-1511, a drug-drug conjugate aimed at advanced solid tumors. The first subject in that Phase I/II study received dosing in March 2024.
