Nuvation Bio’s glioma drug has touted a 36-month progression-free survival (PFS) rate of 79% with nearly 40 months of follow-up, with its advancement to a pivotal study now set.
The Phase II (J201; NCT04458272) study evaluated safusidenib in patients with chemotherapy- and radiotherapy-naïve grade 2 IDH1-mutant glioma.
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In the study, which enrolled 27 patients with this type of brain tumour in Japan, at a median of 38.8 months of follow-up, the confirmed overall response rate (ORR), per Response Assessment in Neuro-Oncology (RANO) for low-grade gliomas (LGG) criteria, was 51.9%.
Median PFS was not reached, and the 36-month PFS rate was 79.1%. Responses were durable, with only one patient who had previously responded experiencing subsequent disease progression. There were also no new safety signals identified in the study.
Nuvation to advance glioma drug to pivotal trial
Nuvation Bio also announced a significant expansion of the clinical development programme for safusidenib, a selective investigational inhibitor of mutant IDH1.
The company will initiate two new studies to evaluate safusidenib across the broader landscape of IDH1-mutant glioma: a pivotal Phase III study in patients with grade 2 IDH1-mutant glioma outside the US (G307; NCT07712757) and a Phase II study in patients with IDH1-mutant glioma that has progressed after prior treatment with vorasidenib in the US (G209; NCT07703436). Vorasidenib is an approved therapy for the treatment of Grade 2 IDH-mutant gliomas.
The Phase III trial will be a randomised, placebo-controlled study that will enrol approximately 140 patients with newly diagnosed grade 2 IDH1-mutant glioma who have not yet received chemotherapy or radiation.
Meanwhile, the G209 will be a multicentre study that will enrol up to 40 patients in the US with grade 2 or 3 IDH1-mutant glioma who have experienced disease progression after treatment with vorasidenib and who remain in need of another option to delay radiation or chemotherapy.
Dr Macarena de la Fuente, chief of the Neuro-Oncology Division and co-director of Clinical Neuro-Oncology for the Brain Tumor Institute at Sylvester Comprehensive Cancer Center, said: “While the introduction of targeted therapies has transformed the treatment landscape for IDH1-mutant glioma, a critical question remains regarding sequencing of treatments once a patient progresses on a first-line inhibitor. The G209 study is a vital step in addressing this clinical gap by evaluating the potential role of safusidenib in patients who have progressed on prior targeted therapy.”
Kelly Sitkin, president and CEO of the American Brain Tumor Association added: “For patients living with an IDH1-mutant glioma, a historically under-studied disease, questions about what to do when a first-line treatment stops working are a major source of anxiety. We are encouraged to see a clinical program of this scale that not only includes a post-vorasidenib trial but also looks comprehensively across different stages of the disease.”
Nuvation’s stock is up on the announcement, from a $5.80 close on 17 July to a 20 July high of $6.50 (correct at 10.15am ET). The company is listed on the New York Stock Exchange (NYSE) and has a market cap of $2.25bn.
Glioblastoma landscape remains barren
Nuvation is also studying safusidenib as a treatment for glioblastoma (GBM), which is classified as a Grade 4 glioma, in the Phase III SIGMA trial (NCT05303519). According to GlobalData analysts, there are only a handful of innovator treatment options approved for this aggressive form of brain cancer.
The marketed products for GBM belong to different drug classes, such as DNA synthesis inhibitors, vascular endothelial growth factor A inhibitors, DNA topoisomerase II inhibitors, and Interferon alpha/beta receptor 1 agonists. This includes Roche’s Avastin (bevacizumab), which is the US standard of care for GBMs that have returned after initial treatments.
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There are other therapies in the pipeline, however, including Hemispherian’s GLIX1, which is in a Phase I/IIa trial in patients with recurrent and progressive GBM and other high-grade gliomas.
Imvax is also heading to regulators to discuss the future of its drug-device combo IGV-001, despite a Phase IIb trial failing to meet its primary endpoint.
