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Nuvation Bio Announces Pivotal Global Phase 3 SIGMA Trial (G203) for Safusidenib in IDH1-Mutant Glioma

Nuvation Bio Inc. Class A (NUVB) 
Company Research Source: Business Wire
Protocol amendment to change SIGMA from a Phase 2 to a Phase 3 study now completeThe currently enrolling SIGMA trial will now include patients with grade 2 astrocytoma with high-risk features in the maintenance setting, in addition to previously eligible patients with high-grade astrocytomaA new exploratory cohort has also been added for patients with grade 3 oligodendroglioma in the post-surgical settingBroad patient population in SIGMA represents most forms of IDH1-mutant glioma that do not have an FDA-approved targeted treatment option NEW YORK--(BUSINESS WIRE)--Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced finalization of a protocol amendment to the ongoing global SIGMA study (also known as G203; NCT05303519) of safusidenib that expands it to a Phase 3 trial. SIGMA is evaluating the efficacy and safety of safusidenib versus placebo for the maintenance treatment of patients with Show less Read more
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