Nuvation Bio expands Phase 3 SIGMA glioma trial to six European countries
Nuvation Bio announced that its Phase 3 SIGMA study of the oral IDH1‑mutant inhibitor safusidenib will add sites in the United Kingdom, France, Sweden, Germany, Italy and Spain. The trial, which already runs in the United States, Australia, China, Canada and Japan, tests safusidenib as maintenance therapy after standard radiotherapy or chemoradiotherapy and temozolomide for patients with IDH1‑mutant astrocytoma. The primary goal is progression‑free survival, assessed by blinded independent central review. The U.S. FDA granted Fast Track designation for safusidenib in August 2026.
Why it matters
The broader geographic footprint may speed patient enrollment and data collection, potentially advancing the timeline for efficacy read‑outs that could affect the company’s valuation. No analyst or company forecast is provided in the materials.
Key facts
- 1Nuvation Bio announced expansion of its Phase 3 SIGMA study to six European nations: United Kingdom, France, Sweden, Germany, Italy and Spain. investing.com
- 2The study evaluates safusidenib as maintenance therapy after standard radiotherapy or chemoradiotherapy and temozolomide in patients with IDH1‑mutant astrocytoma. investing.com
- 3The primary endpoint is progression‑free survival assessed by blinded independent central review. investing.com
- 4The main part of the trial intends to enroll about 300 patients. investing.com
- 5A secondary exploratory cohort is set to include roughly 40 chemotherapy‑ and radiotherapy‑naïve patients with grade 3 IDH1‑mutant oligodendroglioma. investing.com
- 6The U.S. Food and Drug Administration granted Fast Track designation to safusidenib in August 2026. investing.com
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.