Nuvation Bio Announces Positive Updated Phase 2 Data and Expansion of Safusidenib Clinical Program with Two New Studies to Explore Broad Spectrum of IDH1-Mutant Glioma
Rhea-AI Summary
Nuvation Bio (NYSE: NUVB) reported updated long-term Phase 2 (J201) data for safusidenib in chemotherapy- and radiotherapy-naïve grade 2 IDH1-mutant glioma, showing a centrally assessed confirmed overall response rate of 51.9% and a 36-month progression-free survival rate of 79.1% at a median 38.8-month follow-up in 27 patients in Japan. Median progression-free survival was not reached, only one prior responder had subsequent disease progression, and no new safety signals were identified.
According to Nuvation Bio, safusidenib’s clinical program is being expanded with two additional trials: the pivotal Phase 3 G307 study in approximately 140 newly diagnosed grade 2 IDH1-mutant glioma patients outside the U.S., and the Phase 2 G209 study in up to 40 U.S. patients with grade 2 or 3 IDH1-mutant glioma whose disease has progressed after vorasidenib. These studies build on the ongoing pivotal Phase 3 SIGMA (G203) trial in approximately 300 patients with IDH1-mutant astrocytoma with high-risk features and an exploratory cohort of about 40 patients with grade 3 IDH1-mutant oligodendroglioma.
Positive
- 51.9% confirmed ORR and 79.1% 36-month PFS in 27-patient Phase 2 J201 cohort
- Median PFS not reached after 38.8-month median follow-up; only one responder progressed
- No new safety signals observed with long-term safusidenib treatment in Phase 2 J201
- Safusidenib program expanded with two new trials (Phase 3 G307, Phase 2 G209)
- Pivotal Phase 3 safusidenib studies plan to enroll ~440 patients (SIGMA ~300, G307 ~140)
- Exploratory oligodendroglioma cohort adds ~40 additional patients to safusidenib evaluation
Negative
- None.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 06 | FDA filing update | Positive | +4.3% | FDA accepted supplemental application with updated taletrectinib duration-of-response data for advanced ROS1-positive lung cancer. |
| Feb 09 | Phase 3 trial launch | Positive | -1.1% | SIGMA converted to pivotal Phase 3 with expanded enrollment and exploratory oligodendroglioma cohort. |
| Dec 03 | Phase 2 results | Positive | +12.1% | Published positive safusidenib Phase 2 results with ORR and progression-free survival data. |
| Sep 30 | Phase 3 enrollment | Positive | +14.9% | Enrolled first patient in TRUST-IV Phase 3 adjuvant taletrectinib study. |
| Sep 07 | Clinical data presentation | Positive | -10.5% | Presented updated IBTROZI pivotal-study data including response rates and median PFS. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Tag-matched clinical-trial announcements aligned with positive price reactions in three events and diverged in two.
Key Terms
progression-free survival medical
objective response rate medical
bicr medical
tumor growth rate medical
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Updated data from Phase 2 study show confirmed objective response rate of
New Phase 3 study to evaluate safusidenib in newly diagnosed grade 2 glioma patients outside the
New Phase 2 study to evaluate safusidenib in patients whose glioma has progressed following treatment with vorasidenib in
Nuvation Bio also announced a significant expansion of the clinical development program for safusidenib, its selective investigational inhibitor of mutant IDH1, supported by the updated long-term follow-up data from the Phase 2 (J201) study. The company will initiate two new studies to evaluate safusidenib across the broader landscape of IDH1-mutant glioma: a pivotal Phase 3 study in patients with grade 2 IDH1-mutant glioma outside the
"We continue to be very encouraged by the longer-term data from our Phase 2 J201 study, and today's announcement marks a pivotal step forward in our mission to bring safusidenib as a comprehensive treatment option for patients with all types of IDH1-mutant glioma," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "These two new studies are designed to evaluate safusidenib across a broader range of patients with IDH1-mutant glioma, with the ultimate goal of providing an effective therapy for nearly every patient with this disease."
Updated long-term data highlights durable efficacy
The updated results from the Phase 2 (J201) study, from 27 patients in
- The centrally assessed confirmed overall response rate (ORR), per Response Assessment in Neuro-Oncology (RANO) for low grade gliomas (LGG) criteria, was
51.9% . - Median progression-free survival (PFS) was not reached, and the 36-month PFS rate was
79.1% . - Responses were durable, with only one patient who had previously responded experiencing subsequent disease progression.
- No new safety signals were identified.
Expanding the safusidenib clinical development program
The two new studies are designed to broaden the potential number of patients with IDH1-mutant glioma who could benefit from safusidenib:
- G307: A Phase 3, randomized, placebo-controlled study that will enroll approximately 140 patients with newly diagnosed grade 2 IDH1-mutant glioma who have not yet received chemotherapy or radiation. The study will be conducted at sites outside the
U.S . in regions where vorasidenib is not yet approved or accessible, providing this clinical trial as a critical option for patients in need in these regions. The primary endpoint is PFS as assessed by blinded independent central review (BICR). Secondary endpoints include ORR, time to next intervention, duration of response, and time to response. - G209: A Phase 2, multicenter study that will enroll up to 40 patients in the
U.S . with grade 2 or 3 IDH1-mutant glioma who have experienced disease progression after treatment with vorasidenib and who remain in need of another option to delay radiation or chemotherapy. This study seeks to establish proof-of-concept for safusidenib in a setting of high unmet need. The primary endpoint is ORR by BICR, with a number of secondary endpoints, including tumor growth rate (TGR), an emerging way of assessing early anti-tumor activity.
"While the introduction of targeted therapies has transformed the treatment landscape for IDH1-mutant glioma, a critical question remains regarding sequencing of treatments once a patient progresses on a first-line inhibitor," said Macarena de la Fuente, M.D., Chief of the Neuro-Oncology Division and Co-Director of Clinical Neuro-Oncology for the Brain Tumor Institute at Sylvester Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine. "The G209 study is a vital step in addressing this clinical gap by evaluating the potential role of safusidenib in patients who have progressed on prior targeted therapy."
These studies build upon Nuvation Bio's safusidenib clinical development program, which includes the currently enrolling pivotal Phase 3 SIGMA study, evaluating safusidenib compared to placebo as a maintenance therapy after standard-of-care in IDH1-mutant astrocytoma with high-risk features, and a separate, exploratory, non-pivotal cohort evaluating safusidenib in participants with grade 3 IDH1-mutant oligodendroglioma who have not yet received chemotherapy or radiotherapy.
"For patients living with an IDH1-mutant glioma, a historically under-studied disease, questions about what to do when a first-line treatment stops working are a major source of anxiety," said Kelly Sitkin, President and Chief Executive Officer of the American Brain Tumor Association. "We are encouraged to see a clinical program of this scale that not only includes a post-vorasidenib trial but also looks comprehensively across different stages of the disease. Broad, expansive evaluation like this is among the most comprehensive programs our community has seen and represents an important step forward in addressing significant clinical gaps."
About IDH1-mutant Glioma
Gliomas are the most common type of brain cancer in adults worldwide. In the
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 outside the
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, our plans to initiate two new studies for safusidenib and statements regarding 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 May 4, 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.
Nuvation Bio Investor Contact
JR DeVita
ir@nuvationbio.com
Nuvation Bio Media Contact
Kaitlyn Nealy
media@nuvationbio.com
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