Full Press Release Details
Nuvation Bio will present four posters: one will showcase updated long-term Phase 2 results; three posters highlight trial in progress overviews for ongoing safusidenib studies
Poster featuring Phase 2 results to be presented at SNO includes additional data beyond topline results previously announced in July 2026
NEW YORK, Nov. 2, 2026 /PRNewswire/ -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that additional updated results from the Phase 2 J201 study and three posters on ongoing studies of safusidenib, its selective investigational inhibitor of mutant IDH1, will be presented at the Society for Neuro-Oncology (SNO) Annual Meeting taking place November 12–15, 2026, in Philadelphia, PA. Positive topline Phase 2 J201 results were announced in July; additional key data will be featured in the SNO poster.
"Patients with IDH1-mutant glioma are often diagnosed in their 30s and 40s and may live with their disease for many years, underscoring the importance of targeted treatments that can deliver durable responses with a consistent safety profile," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "We look forward to sharing updated Phase 2 results that speak to that need, as well as progress across our expanded safusidenib development program, with the clinicians and patient community working to advance care for people living with IDH1-mutant glioma."
Presentations Overview:
| Title: Updated efficacy and safety results from a Phase 2 study of safusidenib in patients with chemotherapy- and radiotherapy-naïve Grade 2 isocitrate dehydrogenase 1 (IDH1)-mutant glioma Presenter: Yoshiki Arakawa, Kyoto University Graduate School of Medicine, Kyoto, Japan Date: Friday, November 13, 2026 Session Time: 7:30-9:30 p.m. ET |
| Title: SIGMA: A Phase 3 study evaluating maintenance safusidenib vs placebo following radiotherapy (RT) or chemoradiotherapy (CRT) and adjuvant temozolomide (TMZ) in patients with isocitrate dehydrogenase 1 (IDH1)-mutant astrocytoma with high-risk features Presenter: Katherine B. Peters, Duke University Medical Center, Durham, USA Date: Friday, November 13, 2026 Session Time: 7:30-9:30 p.m. ET |
| Title: Open-label, single-arm, exploratory cohort evaluating safusidenib in chemotherapy (CT)- and radiotherapy (RT)-naïve patients with Grade 3 isocitrate dehydrogenase 1 (IDH1)-mutant oligodendroglioma Presenter: Fabio Iwamoto, Columbia University Irving Medical Center, New York, USA Date: Friday, November 13, 2026 Session Time: 7:30-9:30 p.m. ET |
| Title: A Phase 2 study evaluating the efficacy and safety of safusidenib in Grade 2 or 3 isocitrate dehydrogenase 1 (IDH1)-mutant glioma after disease progression (PD) on vorasidenib Presenter: Macarena de la Fuente, Sylvester Comprehensive Cancer Center, University of Miami, Miami, USA Date: Friday, November 13, 2026 Session Time: 7:30-9:30 p.m. ET |
The materials will be made available in the Publications section of Nuvation Bio's website after the presentations. To meet representatives from Nuvation Bio, visit Booth #126.
About IDH1-mutant Glioma Gliomas are the most common type of brain cancer in adults worldwide. In the U.S., nearly 2,500 people are diagnosed with IDH-mutant gliomas each year, of which more than 95% harbor a mutation in the IDH1 gene. Most patients are diagnosed in their 30s and 40s. While patients with IDH1 mutations generally have longer survival times than those with wild-type IDH1, gliomas are not currently curable and prognosis worsens for those with high-risk features, including high grade tumors.
About Safusidenib Safusidenib is an investigational, oral, brain-penetrant, selective inhibitor of mutant IDH1. It is being studied in patient populations with significant unmet medical need, including settings where there are limited or no approved targeted treatment options. 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 early findings support further investigation of safusidenib in the currently enrolling Phase 3 SIGMA study, as well as in the Phase 3 G307 study in regions where vorasidenib is not yet approved or accessible and the Phase 2 G209 study in patients whose cancer has progressed on vorasidenib.
In August 2026, the FDA granted Fast Track Designation to safusidenib for the treatment of IDH1-mutant glioma.
About the SIGMA (G203) Study SIGMA is a pivotal Phase 3 study that will evaluate safusidenib compared to placebo as a maintenance therapy after standard-of-care in IDH1-mutant astrocytoma with high-risk features. The pivotal portion of the study will enroll approximately 300 patients.
A separate, exploratory, non-pivotal cohort will evaluate safusidenib in participants with grade 3 IDH1-mutant oligodendroglioma who have not yet received chemotherapy or radiotherapy. The primary endpoint is objective response rate. This cohort is expected to enroll approximately 40 patients.
About Nuvation Bio Nuvation Bio is a global oncology company focused on tackling some of the toughest challenges in cancer treatment with the goal of developing therapies that create a profound, positive impact on patients' lives. Our diverse pipeline includes taletrectinib (IBTROZI®), a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor; and an innovative drug-drug conjugate (DDC) program.
Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world's leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston, and Shanghai. For more information, visit www.nuvationbio.com or follow the company on LinkedIn and X (@nuvationbioinc).