Phase Ib Clinical Trial of IGV-001 for Patients with Newly Diagnosed Glioblastoma.
Publication/Presentation Date
4-1-2021
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
RESULTS: Thirty-three patients were enrolled, and median follow-up 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;
CONCLUSIONS: IGV-001 was well tolerated, PFS compared favorably with SOC, and evidence suggested an immune-mediated mechanism (ClinicalTrials.gov: NCT02507583).
Volume
27
Issue
7
First Page
1912
Last Page
1922
ISSN
1557-3265
Published In/Presented At
Andrews, D. W., Judy, K. D., Scott, C. B., Garcia, S., Harshyne, L. A., Kenyon, L., Talekar, K., Flanders, A., Atsina, K. B., Kim, L., Martinez, N., Shi, W., Werner-Wasik, M., Liu, H., Prosniak, M., Curtis, M., Kean, R., Ye, D. Y., Bongiorno, E., Sauma, S., … Hooper, D. C. (2021). Phase Ib Clinical Trial of IGV-001 for Patients with Newly Diagnosed Glioblastoma. Clinical cancer research : an official journal of the American Association for Cancer Research, 27(7), 1912–1922. https://doi.org/10.1158/1078-0432.CCR-20-3805
Disciplines
Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods
PubMedID
33500356
Department(s)
Administration and Leadership
Document Type
Article