Nuvation Bio expanded a trial testing its experimental therapy, safusidenib, in people with certain forms of glioma that carry an IDH1 mutation, transitioning the study from a Phase 2 to a pivotal Phase 3 trial.
“Following discussions with regulatory agencies, advocacy groups and physicians, we substantially expanded the study to include most patients with an IDH1-mutant glioma who currently have no approved targeted therapies available,” David Hung, MD, Nuvation’s founder, president, and CEO, said in a company press release.
The SIGMA (NCT05303519) trial was initially designed as a two-part study. The first part launched in 2023 to evaluate the safety of safusidenib in a small number of patients with IDH1-mutant glioma.
The second part, launched a few months ago, was originally set up to test safusidenib against a placebo in 100 people with high-grade IDH1-mutant astrocytoma, an aggressive form of glioma.
This part of the study is now expanding to enroll 300 patients with broader eligibility criteria. The trial is open to patients with grade 2 and 3 IDH1-mutant astrocytoma with high-risk features, and grade 4 IDH1-mutant astrocytoma who have already undergone standard treatments such as radiation. Enrollment is ongoing at sites in the U.S., Australia, and China.
Moving toward FDA approval application
Researchers will test if safusidenib is better than a placebo at delaying cancer progression. If results show it is, Nuvation will use data from this portion of the study as a basis for regulatory applications seeking approval of the therapy.
“These SIGMA protocol updates reflect alignment with U.S. regulators to support the potential approval of safusidenib as swiftly as possible for a patient population that is in dire need of options,” Hung said.
Nuvation is adding a third portion to the study to test safusidenib in people with another form of glioma, oligodendroglioma. This part of the trial aims to enroll about 40 people with grade 3 IDH1-mutant oligodendroglioma who have undergone surgery but have not received chemotherapy or radiation. All patients will receive safusidenib, with the main goal of seeing how many experience a treatment response (a reduction in tumor volume). Hung said the company expects results from this part of the trial in 2027.
High-grade, aggressive gliomas often carry mutations in the IDH1 gene, which contribute to tumor growth. Safusidenib is an oral therapy that blocks tumor growth by inhibiting this mutation. The therapy has shown a good safety profile and antitumor activity in earlier trials, according to Nuvation.
“We are encouraged by the promising results seen in the Phase 2 study, which included both astrocytoma and oligodendroglioma, and are eager to explore the potential of safusidenib across multiple settings through this registrational trial,” Hung said.
David Arons, president and CEO of the National Brain Tumor Society, applauded the decision to expand the trial.
“Patients with IDH1-mutant gliomas face a lack of available therapies with proven ability to extend long-term survival while maintaining quality of life,” Arons said. “This is particularly true for patients with higher-risk or high-grade IDH1-mutant astrocytoma and oligodendroglioma, where available treatment options — including clinical trials specific to their tumor type — are historically few and far between. Including such patients in pivotal trials, we hope, could bring meaningful benefit for this area of high-unmet medical need.”
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