Nuvation Bio to Expand Pivotal Phase 3 SIGMA Study of Safusidenib for IDH1-Mutant Glioma to Six European Countries

The expansion extends SIGMA beyond the U.S., Australia, China, Canada and Japan, where enrollment is underway or will begin soon.

Rhea-AI Summary

Nuvation Bio (NUVB) plans to expand its pivotal Phase 3 SIGMA study of safusidenib to six European countries. New sites will be added in the United Kingdom, France, Sweden, Germany, Italy and Spain, extending a study footprint that includes countries currently enrolling or preparing to enroll patients.

The randomized, placebo-controlled trial evaluates safusidenib as maintenance treatment after standard radiotherapy or chemoradiotherapy and adjuvant temozolomide in patients with IDH1-mutant astrocytoma with high-risk features. The pivotal portion plans to enroll approximately 300 patients, with progression-free survival, or time without disease worsening, assessed by blinded independent central review as its primary endpoint. A separate exploratory cohort will study approximately 40 patients with grade 3 IDH1-mutant oligodendroglioma.

Positive

• Minor point. Forward-looking: it has not happened yet and may not happen.SIGMA's planned expansion adds sites in six European countries to its clinical development footprint.
• Minor point. Forward-looking: it has not happened yet and may not happen.SIGMA's pivotal portion plans to enroll approximately 300 patients to evaluate safusidenib maintenance therapy.
• Minor point. Forward-looking: it has not happened yet and may not happen.An exploratory, non-pivotal cohort is expected to enroll approximately 40 patients with grade 3 IDH1-mutant oligodendroglioma.
• Minor pointSafusidenib received FDA Fast Track Designation for IDH1-mutant glioma in August 2026.

Negative

• None.

Key Figures

European countries added: 6 countries Pivotal study enrollment: approximately 300 patients Exploratory cohort enrollment: approximately 40 patients

European countries added

6 countries

New SIGMA study sites

Pivotal study enrollment

approximately 300 patients

SIGMA pivotal portion

Exploratory cohort enrollment

approximately 40 patients

Grade 3 IDH1-mutant oligodendroglioma cohort

Previous Clinical trial Reports

1 past event · Latest: Feb 09

Same Type 1 event

1. Feb 09

   SIGMA trial advancement

   24h Move

   -1.1%

   Protocol amendment made SIGMA pivotal Phase 3, expanding enrollment to 300 and adding an exploratory cohort.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

placebo-controlled, progression-free survival, blinded independent central review, fast track designation

4 terms

placebo-controlled medical

"Phase 3, randomized, placebo-controlled study evaluating safusidenib"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

progression-free survival medical

"The primary endpoint is progression-free survival"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

blinded independent central review medical

"as assessed by blinded independent central review"

Blinded independent central review is a quality-control step in clinical trials where outside medical experts, who do not know which patients received the experimental therapy, re-examine key measurements (like scans or lab results) to prevent bias. Think of it as neutral referees watching game footage without knowing the teams, which gives investors greater confidence that the trial results are fair, more reliable for regulators, and less likely to be overturned or disputed.

fast track designation regulatory

"FDA granted Fast Track Designation to safusidenib"

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

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

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New sites in the UK, France, Sweden, Germany, Italy and Spain will add to the global footprint of the pivotal SIGMA study

NEW YORK, Oct. 29, 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 the pivotal Phase 3 SIGMA (G203; NCT05303519) study of investigational safusidenib will expand to include study sites in the United Kingdom, France, Sweden, Germany, Italy and Spain. These additional countries extend SIGMA's global footprint beyond the U.S., Australia, China, Canada and Japan, where the study is currently enrolling or will soon begin enrolling. Safusidenib is an oral, brain-penetrant, selective inhibitor of mutant IDH1.

"Our goal is to develop therapies that create a profound, positive impact on patients' lives, and for safusidenib that means building a broad development program that has the potential to reach more people with IDH1-mutant glioma in need of treatment options around the world," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "Expanding SIGMA to sites across six European countries is an important step for patients, and we have been encouraged by the strong interest in the study from physicians and the glioma community in Europe. We sincerely thank the investigators, site teams, patient advocates and patients who will help make this study possible."

SIGMA is a pivotal Phase 3, 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. The pivotal portion of the study is planned to enroll approximately 300 patients, and an exploratory cohort will evaluate safusidenib in approximately 40 chemotherapy- and radiotherapy-naïve patients with grade 3 IDH1-mutant oligodendroglioma.

Study site locations will be listed on ClinicalTrials.gov and updated as finalized.

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). 

Forward-Looking Statements
Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook" and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding our plans to expand the SIGMA study to six European countries, the SIGMA study's patient enrollment goals, and safusidenib's therapeutic potential. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management team of Nuvation Bio and are not predictions of actual performance. These forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to differ from those anticipated by the forward-looking statements, including but not limited to the challenges associated with conducting drug discovery and commercialization, and initiating or conducting clinical studies due to, among other things, difficulties or delays in the regulatory process, enrolling subjects or manufacturing or acquiring necessary products; the emergence or worsening of adverse events or other undesirable side effects; risks associated with preliminary and interim data, which may not be representative of more mature data; physician and patient behavior; and competitive developments. Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-Q filed with the SEC on August 6, 2026, under the heading "Risk Factors," and other documents that Nuvation Bio has filed or will file with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Nuvation Bio disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release.

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.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is the primary endpoint of Nuvation Bio's Phase 3 SIGMA study?

The pivotal portion's primary endpoint is progression-free survival, assessed by blinded independent central review. It compares safusidenib with placebo as maintenance therapy following standard-of-care treatment in patients with IDH1-mutant astrocytoma with high-risk features.

Who is eligible for Nuvation Bio's SIGMA exploratory cohort, and what will it measure?

The exploratory, non-pivotal cohort will evaluate patients with grade 3 IDH1-mutant oligodendroglioma who have not received chemotherapy or radiotherapy, with objective response rate as its primary endpoint. The cohort is expected to enroll approximately 40 patients.