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NUVB expands safusidenib program after strong Phase 2 results in IDH1 glioma

Jul 20, 2026, 8:05 AM EDT1 sourcesAI-analyzed

Why it may matterVerify against the original reporting

Positive long-term implications from expanded trials and durable Phase 2 results; potential later-stage readouts could unlock broader indications and regional approvals.

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NUVB disclosed updated Phase 2 J201 safusidenib data in IDH1-mutant glioma, showing an ORR of 51.9% and a 36-month PFS of 79.1% with median PFS not reached and durable responses; no new safety signals. The company also expanded the safusidenib program, launching a Phase 3 study outside the U.S. (G307) and a Phase 2 study in the U.S. (G209), broadening potential patient access and potential future approvals.

Phase 2 J201: ORR 51.9%, 36-month PFS 79.1%; median PFS not reached.
27 Japanese patients; median follow-up 38.8 months with durable responses.
Nuvation expands safusidenib program with two new studies: G307 outside US, G209 in US.
G307 ~140 patients; G209 up to 40 patients; SIGMA Phase 3 ongoing.
Broader IDH1-mutant glioma program aims for comprehensive treatment options.

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NUVB expands safusidenib program after strong Phase 2 results in IDH1 glioma

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