Phase Ib clinical trial of IGV-001 for patients with newly diagnosed glioblastoma

David W. Andrews, Kevin D. Judy, Charles B. Scott, Samantha Garcia, Larry A. Harshyne, Lawrence Kenyon, Kiran Talekar, Adam Flanders, Kofi Buaku Atsina, Lyndon Kim, Nina Martinez, Wenyin Shi, Maria Werner-Wasik, Haisong Liu, Mikhail Prosniak, Mark Curtis, Rhonda Kean, Donald Y. Ye, Emily Bongiorno, Sami SaumaMark A. Exley, Kara Pigott, D. Craig Hooper

Research output: Contribution to journalArticlepeer-review

13 Scopus citations

Abstract

Purpose: Despite standard of care (SOC) established by Stupp, glioblastoma remains a uniformly poor prognosis. We evaluated IGV-001, which combines autologous glioblastoma tumor cells and an antisense oligonucleotide against IGF type 1 receptor (IMV-001), in newly diagnosed glioblastoma. Patients and Methods: This open-label protocol was approved by the Institutional Review Board at Thomas Jefferson University. Tumor cells collected during resection were treated ex vivo with IMV-001, encapsulated in biodiffusion chambers with additional IMV-001, irradiated, then implanted in abdominal acceptor sites. Patients were randomized to four exposure levels, and SOC was initiated 4-6 weeks later. On the basis of clinical improvements, randomization was halted after patient 23, and subsequent patients received only the highest exposure. Safety and tumor progression were primary and secondary objectives, respectively. Time-to-event outcomes were compared with the SOC arms of published studies. Results: Thirty-three patients were enrolled, and median followup was 3.1 years. Six patients had adverse events (grade ≤3) possibly related to IGV-001. Median progression-free survival (PFS) was 9.8 months in the intent-to-treat population (vs. SOC, 6.5 months; P = 0.0003). In IGV-001-treated patients who met Stupp-eligible criteria, PFS was 11.6 months overall (n = 22; P = 0.001) and 17.1 months at the highest exposure (n = 10; P = 0.0025). The greatest overall survival was observed in Stupp-eligible patients receiving the highest exposure (median, 38.2 months; P = 0.044). Stupp-eligible patients with methylated O6-methylguanine-DNA methyltransferase promoter (n = 10) demonstrated median PFS of 38.4 months (P = 0.0008). Evidence of immune activation was noted. Conclusions: IGV-001 was well tolerated, PFS compared favorably with SOC, and evidence suggested an immune-mediated mechanism.

Original languageEnglish
Pages (from-to)1912-1922
Number of pages11
JournalClinical Cancer Research
Volume27
Issue number7
DOIs
StatePublished - Apr 2021

Fingerprint

Dive into the research topics of 'Phase Ib clinical trial of IGV-001 for patients with newly diagnosed glioblastoma'. Together they form a unique fingerprint.

Cite this