Safusidenib - (J201)

July 20, 2026: Nuvation Bio Inc. (NYSE: NUVB) reported updated long-term follow-up results from the Phase 2 J201 study of safusidenib, an investigational mutant IDH1 inhibitor, in chemotherapy- and radiotherapy-naïve grade 2 IDH1-mutant glioma patients in Japan (n=27). At a median 38.8 months’ follow-up, centrally assessed confirmed ORR (RANO LGG criteria) was 51.9%; median PFS was not reached and the 36‑month PFS rate was 79.1%. Responses were described as durable, with one prior responder later progressing; no new safety signals were identified.

The company also announced an expansion of safusidenib’s development program with two new trials:

• G307 (NCT07712757): Pivotal Phase 3 randomized, placebo-controlled study (~140) in newly diagnosed grade 2 IDH1-mutant glioma patients outside the U.S. who have not received chemotherapy/radiation; primary endpoint PFS by BICR.
• G209 (NCT07703436): Phase 2 multicenter U.S. study (up to 40) in grade 2/3 IDH1-mutant glioma that progressed after vorasidenib; primary endpoint ORR by BICR, with secondary endpoints including tumor growth rate.

Nuvation Bio noted the ongoing, currently enrolling pivotal Phase 3 SIGMA (G203) maintenance study in high-risk IDH1-mutant astrocytoma, plus a non-pivotal cohort in grade 3 IDH1-mutant oligodendroglioma.