Nuvation Bio reports 51.9% response rate for safusidenib in Phase 2 glioma study

• Nuvation Bio (NYSE:NUVB) reported updated Phase 2 data for safusidenib showing a confirmed overall response rate of 51.9% in grade 2 IDH1-mutant glioma patients.
• The company's shares traded near $4.10 following the clinical data update and pipeline expansion announcement.
• Management announced the clinical program is expanding with two new trials, adding to the ongoing pivotal Phase 3 SIGMA trial.

Nuvation Bio (NYSE:NUVB) reported updated long-term Phase 2 data for safusidenib in chemotherapy- and radiotherapy-naïve grade 2 IDH1-mutant glioma.

The evaluation of 27 patients in Japan demonstrated a centrally assessed confirmed overall response rate of 51.9% and a 36-month progression-free survival rate of 79.1% at a median follow-up of 38.8 months.

Median progression-free survival was not reached, only one prior responder experienced subsequent disease progression, and no new safety signals were identified.

Following the announcement, Nuvation Bio shares traded near $4.10.

According to the company, safusidenib’s clinical program is expanding 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 new evaluations build directly on the ongoing pivotal Phase 3 SIGMA (G203) trial, which is currently evaluating approximately 300 patients with IDH1-mutant astrocytoma with high-risk features alongside an exploratory cohort of about 40 patients with grade 3 IDH1-mutant oligodendroglioma.