Glioblastoma Multiforme: 80% 6-Month Progression-Free Survival In Phase 2 Study with INO-5401 In Combination with PD-1 Inhibitor (cemiplimab)
Inovio Pharmaceuticals, Inc. - Nov 05, 2019
Glioblastoma multiforme has generally proven refractory to immune-focused therapies. Early data suggest efficacy for combination anti-PD1, multi-epitope vaccine (hTERT, WT1 & PSMA) and IL-12, with 80% PFS at 6 months surpassing historical controls.
The trial was designed to evaluate safety, immunogenicity and preliminary efficacy of INO-5401 and INO-9012 in combination with Libtayo, with radiation and chemotherapy, in subjects with newly-diagnosed glioblastoma (GBM). This is a Phase 1/2, open-label, multi-center trial conducted in 52 evaluable patients with GBM. There were 2 cohorts in this trial. Cohort A were participants with a tumor with an unmethylated O6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) promoter. Cohort B included participants with a tumor with a MGMT methylated promoter or who have indeterminate MGMT status. Both cohorts received INO-5401 and INO-9012 and Libtayo at the same doses and on the same dosing schedule, and both cohorts received radiation and temozolomide (TMZ), if clinically indicated. Interim data presented here and at SITC was obtained as of October 2019 and final study data is expected in Q4 2020. For more information of the clinical study, see www.clinicaltrials.gov, identifier NCT03491683.