CTIM-14. EARLY SAFETY DATA FROM A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PHASE 2B STUDY OF IGV-001, AN AUTOLOGOUS CELL IMMUNOTHERAPY, VERSUS PLACEBO, IN NEWLY DIAGNOSED GLIOBLASTOMA (NDGBM)

Abstract Standard of care (SOC) for ndGBM begins with maximal safe resection followed by adjuvant radiotherapy and temozolomide, and maintenance temozolomide. IGV-001 is an autologous biologic-device combination immunotherapy for the treatment of ndGBM that consists of autologous GBM tumor cells and an antisense oligonucleotide against IGF-1R mRNA, irradiated and administered via biodiffusion chambers implanted in the abdomen. In a phase 1b study, IGV-001 was well tolerated without unexpected adverse events in subjects with ndGBM. Multiple efficacy signals were observed, including significant improvements in progression-free survival (PFS), overall survival (OS), radiographic evidence of tumor response, and changes in immune response biomarkers. Here, we present early safety data from the phase 2b randomized, multicenter, double-blind, placebo-controlled study (NCT04485949) designed to assess efficacy and safety of IGV-001 in subjects with ndGBM across 20 sites in the United States. After surgical resection, subjects were randomized 2:1 and treated with IGV-001 or placebo followed by SOC. The primary outcome is PFS, defined as the time from randomization to first progression, as determined by blinded central radiology review, or death. Secondary outcomes include OS, defined as the time from randomization to death due to any cause, and safety. As of May 22, 2024, 99 subjects were randomized and 95 implanted with IGV-001 or placebo plus SOC. A total of 39/45 (86.7%) subjects had sufficient follow-up time after initiated treatment with concurrent radiation and temozolomide. Nine of 72 randomized (12.5%) discontinued treatment, including 7 who stopped during the SOC treatment period. None ceased treatment for adverse events, protocol deviations, or death. A total of 11/72 (15.3%) randomized subjects discontinued the study after randomization. A review of blinded safety data did not show any emerging risk and supports no change to the benefit-risk profile of IGV-001 versus placebo. Updated data will be presented.

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Publication Details

Journal
Neuro-Oncology
Published
2024-11-01
DOI
https://doi.org/10.1093/neuonc/noae165.0347
Primary Topic
Glioma Diagnosis and Treatment
Type
article
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article

CTIM-14. EARLY SAFETY DATA FROM A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PHASE 2B STUDY OF IGV-001, AN AUTOLOGOUS CELL IMMUNOTHERAPY, VERSUS PLACEBO, IN NEWLY DIAGNOSED GLIOBLASTOMA (NDGBM)

Athar N. Malik, Dominique Higgins, Soma Sengupta, Kyle C. Wu et al.
Neuro-Oncology
Glioma Diagnosis and Treatment
article

CTIM-14. EARLY SAFETY DATA FROM A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PHASE 2B STUDY OF IGV-001, AN AUTOLOGOUS CELL IMMUNOTHERAPY, VERSUS PLACEBO, IN NEWLY DIAGNOSED GLIOBLASTOMA (NDGBM)

Athar N. Malik, Dominique Higgins, Soma Sengupta, Kyle C. Wu, Morana Vojnic, Synphen H. Wu, Rohan Ramakrishna, Carlos Eduardo Silva Correia, Pierre Giglio, Brad E. Zacharia, Suriya Jeyapalan, Adı́lia Hormigo, Tobias Walbert, Michael Schulder, Charles Scott, David W. Andrews, Rajiv Magge, Adam Robin, A. Gabriella Wernicke, Eric T. Wong, John A. Boockvar, Saadi Ghatan, Gregory Pennock, Mahua Dey, Vijay Agarwal, Lyndon Kim, Linton T. Evans, Simon Hanft, Julian K. Wu, Dawit Gebremichael Aregawi, Raul Perez-Olle, Iyad Alnahhas, Samuel Singer, Ankush Bhatia, Laura L. Neese, Nitesh V. Patel, Nelson S. Moss, Amy B. W. Chan, Brian Gill, Cameron Brennan, FABIO MASSAITI IWAMOTO, J. Bradley Elder, Cristina Falo, Ian Lee, Christopher James Farrell, Alfredo Quiñones-Hinojosa, Wendy Sherman, Robert Maurer
article en

Abstract

Abstract Standard of care (SOC) for ndGBM begins with maximal safe resection followed by adjuvant radiotherapy and temozolomide, and maintenance temozolomide. IGV-001 is an autologous biologic-device combination immunotherapy for the treatment of ndGBM that consists of autologous GBM tumor cells and an antisense oligonucleotide against IGF-1R mRNA, irradiated and administered via biodiffusion chambers implanted in the abdomen. In a phase 1b study, IGV-001 was well tolerated without unexpected adverse events in subjects with ndGBM. Multiple efficacy signals were observed, including significant improvements in progression-free survival (PFS), overall survival (OS), radiographic evidence of tumor response, and changes in immune response biomarkers. Here, we present early safety data from the phase 2b randomized, multicenter, double-blind, placebo-controlled study (NCT04485949) designed to assess efficacy and safety of IGV-001 in subjects with ndGBM across 20 sites in the United States. After surgical resection, subjects were randomized 2:1 and treated with IGV-001 or placebo followed by SOC. The primary outcome is PFS, defined as the time from randomization to first progression, as determined by blinded central radiology review, or death. Secondary outcomes include OS, defined as the time from randomization to death due to any cause, and safety. As of May 22, 2024, 99 subjects were randomized and 95 implanted with IGV-001 or placebo plus SOC. A total of 39/45 (86.7%) subjects had sufficient follow-up time after initiated treatment with concurrent radiation and temozolomide. Nine of 72 randomized (12.5%) discontinued treatment, including 7 who stopped during the SOC treatment period. None ceased treatment for adverse events, protocol deviations, or death. A total of 11/72 (15.3%) randomized subjects discontinued the study after randomization. A review of blinded safety data did not show any emerging risk and supports no change to the benefit-risk profile of IGV-001 versus placebo. Updated data will be presented.

Neuro-OncologyVol. 26(Supplement_8)
University of North Carolina at Chapel Hill (US), Tufts University (US), Albert Einstein College of Medicine (US), Northwell Health (US), Westchester Medical Center (US), Memorial Sloan Kettering Cancer Center (US), University of Wisconsin–Madison (US), Hofstra University (US), Thomas Jefferson University (US), Henry Ford Health System (US), Cornell University (US), Brown University (US), Rhode Island Hospital (US), North Shore University Hospital (US), Lenox Hill Hospital (US), Jacksonville College (US), Mount Sinai Medical Center (US), Jersey Shore University Medical Center (US), Weill Cornell Medicine (US), The Ohio State University (US), Columbia University (US), University of Pennsylvania (US), Penn State Milton S. Hershey Medical Center (US)
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