Cited by 147Immunotherapy and Immune ResponsesLung Cancer Treatments and MutationsLung Cancer Research Studies

Phase II trial of Belagenpumatucel-L, a TGF-β2 antisense gene modified allogeneic tumor vaccine in advanced non small cell lung cancer (NSCLC) patients

Nemunaitis, J, Nemunaitis, M, Senzer, N, Snitz, P, Bedell, C, Kumar, P, Pappen, B, Maples, P B +2 more·2009·Cancer Gene Therapy

Abstract

In a previous dose escalation trial we demonstrated dose related survival correlation to Belagenpumatucel-L. In order to further evaluate safety and response at the previously defined optimal dose and schedule and to gain preliminary evidence on a hypothesis that the level of circulating tumor cells (CTCs) in blood may correlate with the overall survival of patients with stage IV NSCLC, we initiated a phase II trial. Patients received intradermal immunization of 2.5 x 10(7) transfected allogeneic tumor cells (Belagenpumatucel-L, supplied by NovaRx) 1 x every month for a total of 16 months. Circulating tumor cells (Veridex, Raritan, NJ) were measured every 4 weeks. Twenty-one advanced NSCLC patients were enrolled on this study. No significant toxic effect was observed. Overall survival was 562 days. The median survival was 660 days in patients having less than 2 CTCs at baseline compared to 150 days in patients with 2 or more CTCs (P=0.025). Phase II results of safety and response are consistent with prior experience following treatment with Belagenpumatucel-L and there is a suggestion that the number of circulating tumor cells at baseline appears to correlate with overall survival. A larger clinical trial is warranted to further explore this observation.

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Crossref · 10.1038/cgt.2009.15

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  • A phase 3 clinical trial of the anti-sense TGF-β2 vaccine did not meet its endpoint of increased overall survival.

    “a phase 3 clinical trial did not meet its endpoint of increased overall survival371.”

    From TGFβ biology in cancer progression and immunotherapy (2021) · cites this paper as [371]

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Authors
Nemunaitis, J., Nemunaitis, M., Senzer, N., Snitz, P., Bedell, C., Kumar, P., Pappen, B., Maples, P. B., Shawler, D., & Fakhrai, H.
Affiliations
  • Mary Crowley Cancer Research Center (US)
  • Baylor University Medical Center (US)
  • Gradalis (United States) (US)
  • NovaRx (United States) (US)
Corresponding author
Nemunaitis, J
Venue
Cancer Gene Therapy
Published
2009-03-13
Volume
16
Issue
8
Pages
620-624
ISSN
  • 0929-1903 (ISSN-L)
  • 1476-5500
OpenAlex
W1993615391
Cited by
147
References
36
Citations by year
2026: 1 · 2025: 4 · 2024: 10 · 2023: 4 · 2022: 11 · 2021: 8 · 2020: 4 · 2019: 4 · 2018: 2 · 2017: 7 · 2016: 8 · 2015: 11 · 2014: 17 · 2013: 19 · 2012: 15
FWCI
5.02
Type
journal article
Language
en
Open access
closed
Locations
  • Cancer Gene Therapy (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
  • Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
Keywords
non-small cell lung cancer, circulating tumor cells, overall survival, intradermal vaccination, gene-modified tumor cells, vaccine safety, stage IV NSCLC
MeSH terms
Adult, Aged, Carcinoma, Non-Small-Cell Lung, Dose-Response Relationship, Drug, Female, Humans, Injections, Intradermal, Lung Neoplasms, Male, Middle Aged, Tumor Cells, Cultured, Genetic Therapy, DNA, Antisense, Disease Progression, Cancer Vaccines, Transforming Growth Factor beta2

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