Interim Analysis Demonstrates Reassuring Toxicity Profile for Glioblastoma

David Reardon, MD, clinical director for the Center for Neuro-Oncology and institute physician at the Dana-Farber Cancer Institute, and professor of medicine at Harvard Medical School, discusses the interim results and toxicity with INO-5401 and INO-9012 delivered intramuscularly with electroporation in combination with cemiplimab (Libtayo) in patients with newly diagnosed glioblastoma.

According to Reardon, these agents were well tolerated and there were no significant adverse effects (AEs) associated with the vaccine. Cemiplimab showed the usual spectrum of AEs that are usually associated with PD-1 inhibitor therapies and there were no unexpected or new toxicities in the context of treating patients with glioblastoma.

There were 52 patients treated on the trial; 32 in cohort A, which was the O6-methylguanine-DNA methyltransferase (MGMT) unmethylated group, and 20 in cohort B, which was MGMT methylated. All of these patients had a reassuring safety profile, Reardon says.

It is too early to assess the efficacy of the regimen in these patients, but initial results showed encouraging progression-free survival results at 6 months and overall survival at 12 months. They were both higher than what would be expected at the time of the interim analysis for patients with newly diagnosed disease, according to Reardon. It is still too early to draw conclusions with these data.

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