INOVIO Announces Survival Results for INO-5401 + INO-9012 in Combination with Libtayo(R) in Patients with Newly Diagnosed GBM
May 27, 2022 at 08:06 am EDT
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INOVIO announced results from the company's novel Phase 1/2 trial of INO-5401 and INO-9012 in combination with PD-1 inhibitor Libtayo(R) (cemiplimab) in the treatment of newly diagnosed glioblastoma (GBM), including encouraging median overall survival (OS) data from fifty-two subjects. Median OS duration in unmethylated MGMT (Cohort A) was 17.9 months. Median OS data in MGMT Methylated patients (Cohort B) are being presented for the first time, at a median of 32.5 months, which compares favorably to historical comparisons (23.2-25 months). Overall, INO-5401 + INO-9012 is demonstrated to be tolerable and immunogenic when administered with Libtayo and RT/TMZ (radiation and temozolomide) to newly diagnosed GBM patients. Notably, INO-5401 elicited antigen-specific T cells that may infiltrate GBM tumors. The data from this study was selected to be presented in an oral presentation by Dr. David Reardon on, June 6, 2022, at the 2022 American Society of Clinical Oncology (ASCO) at the McCormick Place Convention Center in Chicago, Illinois. The adverse event profile was consistent with known single-agent (INO-5401, INO-9012, EP or Libtayo) events; most events were <=Grade 2 and no related events were Grade >=4. Median OS durations in Cohorts A and B were 17.9 months (95% CI 14.5-19.8) and 32.5 months (95% CI 18.4-not reached), respectively. Flow cytometry revealed activated, antigen specific CD4+CD69+PD1+ and CD8+CD69+PD1+ T cells, the latter with lytic potential as defined by presence of perforin and granzyme
A. Both subsets exhibited HR < 1.0 and p < 0.05 when accounting for a 0.1% T cell frequency change, translating to a 23% and 28% reduced risk of death at 18 months, respectively.
Inovio Pharmaceuticals, Inc. is a clinical-stage biotechnology company. The Company is focused on developing and commercializing deoxyribonucleic acid (DNA) medicines to help treat and protect people from diseases associated with human papillomavirus (HPV), cancer, and infectious diseases. Its DNA medicines pipeline include INO-3107 for HPV-related recurrent respiratory papillomatosis (RRP); INO-3112 for the treatment of HPV-related Oropharyngeal Squamous Cell Carcinoma, or OPSCC; VGX-3100 for the treatment of Anal or Perianal HSIL; INO-5401 for the treatment of Glioblastoma Multiforme (GBM), and INO-5401 for the Treatment of Glioblastoma Multiforme (GBM). Its lead candidate is INO-3107 for the treatment of RRP, a rare and debilitating disease of the respiratory tract caused by HPV infection. Its DNA medicines platform consists of DNA plasmids and its CELLECTRA devices, which are used to deliver the DNA plasmids into the cell. Its CELLECTRA device portfolio consists of two models.