Imvax undeterred by primary endpoint miss in glioblastoma trial

Imvax shared top line results from its phase 2b clinical trial of its cell therapy-device combination product in 99 patients with newly diagnosed glioblastoma (ndGBM), in which the study missed its primary endpoint.

IGV-001, the first product of Imvax’s Goldspire immuno-oncology platform, is an autologous product that combines personalized whole tumor-derived cells with an antisense oligonucleotide in implantable biodiffusion chambers, with the goal of inducing a tumor-specific immune response in patients with ndGBM.

The trial did not reach statistical significance on progression-free survival (PFS) but demonstrated a 6.3 month increase in median overall survival and a favorable safety profile.

According to Imvax, to date, approximately 100 ndGBM patients have received treatment with IGV-001 across two clinical studies. Because patients in the IGV-001 arm saw “measurable patient benefit across multiple metrics compared to the placebo arm,” the company intends to submit a meeting request with the FDA to discuss the regulatory pathway for IGV-001.

Glioblastoma is the most common and aggressive malignant brain cancer, with an average life expectancy of 12 to 15 months with the current standard of care. The FDA has granted fast track and orphan drug designation to IGV-001 for the treatment of ndGBM.

Last week, Genenta Science shared an update from its ongoing phase 1/2a study in newly diagnosed glioblastoma multiforme patients with an unmethylated MGMT gene promoter — a subtype of glioblastoma that occurs in patients who are resistant to temozolomide therapy. In the 25-person trial, 44% of patients have reached 18-month survival, compared to 38% reported in April. Two-year survival rate continues to be 29% and median overall survival remains at 17 months.