Safusidenib Demonstrates Durable Responses and Prolonged Disease Control in Grade 2 IDH1-Mutant Glioma
Updated Results from the Phase 2 J201 Trial
Updated Results from the Phase 2 J201 Trial
Clinical Summary:
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Design/Population: The phase 2 J201 trial evaluated safusidenib, a selective mutant IDH1 inhibitor, in patients with chemotherapy- and radiotherapy-naïve grade 2 IDH1-mutant glioma.
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Key Outcomes: At a median follow-up of 38.8 months, safusidenib achieved a centrally assessed confirmed objective response rate of 51.9%. Median progression-free survival was not reached, the 36-month progression-free survival rate was 79.1%. No new safety signals were identified.
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Clinical Relevance: These findings support the continued development of safusidenib across multiple IDH1-mutant glioma settings, including newly diagnosed disease, progression following vorasidenib, and maintenance treatment after standard-of-care therapy.
Updated findings from the phase 2 J201 trial demonstrated that safusidenib, a selective mutant IDH1 inhibitor, produced durable responses and prolonged disease control in patients with chemotherapy- and radiotherapy-naïve grade 2 IDH1-mutant glioma, supporting expansion of the clinical development program into broader patient populations.
In this study, 27 patients with chemotherapy- and radiotherapy-naïve grade 2 IDH1-mutant glioma received safusidenib. The primary end point was objective response rate (ORR) according to Response Assessment in Neuro-Oncology (RANO) criteria for low-grade glioma. Secondary end points included progression-free survival (PFS), duration of response, and safety.
At a median follow-up of 38.8 months, the centrally assessed confirmed ORR was 51.9%. Median PFS was not reached, and the estimated 36-month PFS rate was 79.1%. Responses remained durable, with only 1 patient who achieved an objective response subsequently experiencing disease progression. No new safety signals were identified, and the safety profile remained consistent with previous reports.
Based on this updated data, Nuvation Bio announced the expansion of the safusidenib clinical development program. The phase 3 G307 will evaluate safusidenib versus placebo in approximately 140 patients with newly diagnosed grade 2 IDH1-mutant glioma who have not received chemotherapy or radiotherapy in regions outside of the United States where vorasidenib is not approved or widely available. The primary end point is PFS, as assessed via blinded independent central review.
The company also announced the phase 2 G209 study, which will enroll up to 40 patients in the United States with grade 2 or 3 IDH1-mutant glioma whose disease has progressed following prior treatment with vorasidenib. The primary end point is ORR, with secondary end points including tumor growth rate and additional efficacy measures.
“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,” stated Macarena de la Fuente, MD, Sylvester Comprehensive Cancer Center, Miami, Florida. “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.”
The new studies build upon the broader safusidenib clinical development program, which also includes the ongoing pivotal phase 3 SIGMA trial evaluating safusidenib versus placebo as maintenance therapy following standard-of-care treatment in patients with IDH1-mutant astrocytoma with high-risk features. The pivotal portion of SIGMA is expected to enroll approximately 300 patients.
In addition, SIGMA includes an exploratory, nonpivotal cohort evaluating safusidenib in approximately 40 patients with grade 3 IDH1-mutant oligodendroglioma who have not received chemotherapy or radiotherapy. The primary end point for this cohort is ORR.
Collectively, the J201, G307, G209, and SIGMA studies are evaluating safusidenib across newly diagnosed, maintenance, and post-vorasidenib treatment settings in patients with IDH1-mutant glioma.
Source:
Nuvation Bio Inc. 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. Accessed July 20, 2026. https://investors.nuvationbio.com/news/news-details/2026/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/
