Nuvation Bio Inc. announced on October 29, 2026 that its pivotal Phase 3 SIGMA study of investigational safusidenib will expand to include sites in the United Kingdom, France, Sweden, Germany, Italy, and Spain.

Key Highlights

  • Six new countries added: The SIGMA study will expand to the UK, France, Sweden, Germany, Italy, and Spain, extending beyond its current footprint in the U.S., Australia, China, Canada, and Japan.
  • Study design: SIGMA is a randomized, placebo-controlled Phase 3 study evaluating safusidenib as maintenance therapy in patients with IDH1-mutant astrocytoma with high-risk features, with progression-free survival as the primary endpoint.
  • Enrollment targets: The pivotal portion of the study plans to enroll approximately 300 patients; a separate exploratory cohort will enroll approximately 40 patients with grade 3 IDH1-mutant oligodendroglioma.
  • FDA Fast Track Designation: In August 2026, the FDA granted Fast Track Designation to safusidenib for the treatment of IDH1-mutant glioma, according to the filing.
  • Additional studies: Safusidenib is also being evaluated in the Phase 3 G307 study and the Phase 2 G209 study, the company disclosed.
  • Disease context: According to the filing, nearly 2,500 people in the U.S. are diagnosed with IDH-mutant gliomas each year, of which more than 95% harbor a mutation in the IDH1 gene.

SIGMA Study European Expansion: Sites, Design, and Safusidenib Background

Nuvation Bio Inc. (NYSE:NUVB) disclosed on October 29, 2026 that it will add clinical trial sites across six European countries to its pivotal Phase 3 SIGMA (G203; NCT05303519) study. According to the announcement, these new sites in the United Kingdom, France, Sweden, Germany, Italy, and Spain will join locations in the U.S., Australia, China, Canada, and Japan, where the study is currently enrolling or will soon begin enrolling. The company's founder, president, and CEO David Hung, M.D., stated that the expansion is "an important step for patients," citing strong interest from physicians and the glioma community in Europe.

The filing describes SIGMA as a randomized, placebo-controlled study evaluating safusidenib as maintenance therapy following standard-of-care radiotherapy or chemoradiotherapy and adjuvant temozolomide in patients with IDH1-mutant astrocytoma with high-risk features. The primary endpoint is progression-free survival as assessed by blinded independent central review. A separate exploratory, non-pivotal cohort will evaluate safusidenib in approximately 40 chemotherapy- and radiotherapy-naive patients with grade 3 IDH1-mutant oligodendroglioma, with objective response rate as that cohort's primary endpoint.

Nuvation Bio characterizes safusidenib as an investigational, oral, brain-penetrant, selective inhibitor of mutant IDH1. The company noted that in Phase 1 and Phase 2 clinical studies, safusidenib "demonstrated encouraging clinical activity, including delayed disease progression and durable responses across a range of tumor grades and risk groups, with a favorable risk-benefit profile." These characterizations are the company's own and are subject to its cautionary forward-looking statements language. Nuvation Bio's pipeline also includes taletrectinib (IBTROZI), a next-generation ROS1 inhibitor, and a drug-drug conjugate program, according to the filing.

What Was Disclosed

Nuvation Bio announced the geographic expansion of the Phase 3 SIGMA study of safusidenib to six European countries, described the study's design and enrollment goals, and noted the FDA's August 2026 Fast Track Designation for safusidenib in IDH1-mutant glioma.