Global oncology firm Nuvation Bio Inc. (Nuvation Bio (NUVB)) on Monday revealed updated long-term data from a mid-stage trial evaluating safusidenib for grade 2 IDH1-mutant glioma patients who have not yet received chemotherapy or radiotherapy. Following the announcement, the stock jumped over 11%.

Grade 2 IDH1-mutant gliomas are slow-growing but infiltrative primary brain tumors.

Long-Term Phase 2 Trial Efficacy

With a median follow-up period of 38.8 months in the Phase 2 J201 study, which observed 27 patients in Japan, therapeutic responses to safusidenib increased and deepened over the additional year. The centrally assessed confirmed overall response rate reached 51.9%. Furthermore, the median progression-free survival (PFS) had not yet been reached, while the 36-month PFS rate stood at an impressive 79.1%.

Nuvation Bio highlighted that these clinical responses were highly durable. Notably, only a single patient who had previously responded to the therapy experienced subsequent disease progression. Throughout this extended period, the treatment's safety profile remained consistent and manageable, with no new safety signals identified.

Nuvation Bio Broadens Safusidenib Pipeline

Backed by this supportive long-term data, the oncology company is launching two new clinical studies to evaluate the therapy across a wider landscape of IDH1-mutant glioma patients.

The first new trial, designated G307, is a pivotal Phase 3 randomized, placebo-controlled study designed to enroll roughly 140 patients with newly diagnosed grade 2 IDH1-mutant glioma. The study targets regions outside the U.S. where alternative treatments like vorasidenib remain unapproved or inaccessible. Its primary endpoint is PFS, with secondary measures including overall response rate and duration of response.

The second trial, G209, is a U.S.-based multicenter Phase 2 study enrolling up to 40 patients with grade 2 or 3 IDH1-mutant glioma. It specifically targets patients whose disease progressed after prior vorasidenib treatment, seeking to establish proof-of-concept for patients needing immediate options to delay chemotherapy or radiation.

These upcoming studies build upon the company's existing programs, including the currently enrolling Phase 3 SIGMA trial testing the drug as a maintenance therapy for astrocytoma, and a separate exploratory cohort for grade 3 oligodendroglioma.

NUVB Stock Price Activity: Nuvation Bio shares were up 11.29% at $6.45 at the time of publication on Monday, according to market data.