Nuvation Bio to Present Additional Updated Phase 2 Results at 2026 Society for Neuro-Oncology Annual Meeting

Nuvation Bio (NUVB) will present updated Phase 2 safusidenib results at the Society for Neuro-Oncology meeting on November 13, 2026.

Rhea-AI Summary

Nuvation Bio (NUVB) will present updated Phase 2 safusidenib results at the Society for Neuro-Oncology meeting on November 13, 2026. The J201 poster will include additional long-term efficacy and safety data beyond the topline results announced in July 2026, covering patients with Grade 2 IDH1-mutant glioma who have not received chemotherapy or radiotherapy.

Three other posters will describe ongoing studies: the Phase 3 SIGMA maintenance study in astrocytoma with high-risk features; an exploratory cohort in previously untreated Grade 3 oligodendroglioma; and a Phase 2 study in Grade 2 or 3 glioma after progression on vorasidenib. Safusidenib is an investigational inhibitor of mutant IDH1. Presentation materials will be available in the Publications section of the company's website after the presentations.

Key Terms

idh1, open-label, single-arm, objective response rate, +1 more

5 terms

idh1 medical

"isocitrate dehydrogenase 1 (IDH1)-mutant glioma"

IDH1 is the gene and the enzyme it encodes, isocitrate dehydrogenase 1, which normally helps cells convert isocitrate into alpha‑ketoglutarate while producing NADPH and is active in the cell’s cytosol and peroxisomes. Certain mutations in IDH1 give the enzyme a new activity that produces the oncometabolite 2‑hydroxyglutarate; those mutant forms are biologically and clinically distinct from the normal enzyme and are commonly referenced in diagnostics and drug development for some cancers.

open-label medical

"Open-label, single-arm, exploratory cohort"

Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.

single-arm medical

"Open-label, single-arm, exploratory cohort"

A single-arm study is a clinical trial that gives all participants the same treatment and does not include a separate comparison group or placebo. Think of it like testing a new recipe by serving it to diners without offering a control dish — you can see how people respond, but you can’t directly compare results to another option. For investors, single-arm trials can speed development and reduce cost but leave more uncertainty about how a treatment stacks up against existing therapies and how regulators will view the evidence.

objective response rate medical

"The primary endpoint is objective response rate."

The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.

chemoradiotherapy medical

"following radiotherapy (RT) or chemoradiotherapy (CRT)"

A cancer treatment that combines chemotherapy (drugs that travel through the body to kill or weaken cancer cells) with radiotherapy (high-energy beams aimed directly at a tumor). Using both at once is like attacking a problem with a spray and a spotlight — the drug treats hidden or spreading disease while radiation targets the visible tumor — and it matters to investors because combined regimens can change drug demand, treatment costs, regulatory pathways, and reimbursement decisions.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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). 

Media and Investor Contacts

Nuvation Bio Investor Contact
JR DeVita
ir@nuvationbio.com

Nuvation Bio Media Contact
Kaitlyn Nealy
media@nuvationbio.com

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SOURCE Nuvation Bio Inc.