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Inovio Demonstrates 80% 6-Month Progression-Free Survival In Phase 2 Glioblastoma Multiforme (GBM) Study with INO-5401 In Combination with PD-1 Inhibitor Libtayo® (cemiplimab)
80% of Methylated Patients and 75% of Unmethylated Patients Were Disease Progression-Free at 6 Months PLYMOUTH MEETING, Pennsylvania, Nov. 5, 2019
About this update from Inovio Pharmaceuticals, Inc.
[{"type":"text","content":"80% of Methylated Patients and 75% of Unmethylated Patients Were Disease Progression-Free at 6 Months\n PLYMOUTH MEETING, Pennsylvania, Nov. 5, 2019 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today positive interim results from Inovio's Phase 2 study (NCT03491683) of newly diagnosed glioblastoma multiforme (GBM) combining Inovio's INO-5401, a T cell-activating immunotherapy encoding for three tumor-associated antigens (hTERT, WT1, and PSMA), and INO-9012, an immune activator encoding IL-12, in combination with Libtayo® (cemiplimab), a PD-1 blocking antibody developed by Regeneron Pharmaceuticals (NASDAQ: REGN) in collaboration with Sanofi. The data will be featured in a late-breaking poster presentation at the Society for Immunotherapy of Cancer (SITC) 2019 Annual Meeting in National Harbor, Maryland, November 6-10.\nKey interim data from the 52-patient clinical trial showed that 80% (16 of 20) of MGMT gene promoter methylated patients and 75% (24 of 32) of unmethylated patients were progression-free at six months (PFS6) measured from the time of their first dose, substantially exceeding historical standard-of-care data.\nThis immunotherapy combination with a PD-1 checkpoint inhibitor also exhibited supportive safety, tolerability, and immunogenicity data and suggested an acceptable safety profile consistent with that of Libtayo and Inovio's platform technology. The majority of patients tested had a T cell immune response to one or more tumor-associated antigens encoded by INO-5401. Immune responses to all three tumor-associated antigens were demonstrated in this study. Inovio plans to report 12- and 18-month overall survival data next year. \nDr. David Reardon, M.D., Coordinating Principal Investigator of the study and the Clinical Director for Neuro-Oncology at the Dana-Farber Cancer Institute, said, \"This innovative trial provides promising information that the combination of INO-5401 plus INO-9012, a T cell-promoting therapy, combined with Libtayo, a checkpoint inhibitor, may provide clinically meaningful benefit in this very difficult to treat disease.\"\nDr. J. Joseph Kim, Inovio's President & CEO, said, \"Our new data demonstrates the potential of our immunotherapies utilizing tumor-associated antigens in cancer treatments. Our goal in this GBM trial is to increase progression-free and overa...