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Updated: Feb 17, 2026

Paramyxoviruses for Tumor-targeted Immunomodulation: Design and Evaluation Ex Vivo
Published on: January 7, 2019
GVAX (GMCSF gene modified tumor vaccine) in advanced stage non small cell lung cancer
1US Oncology, Dallas, TX, USA. john.nemunaitis@usoncology.com
Abstract:
Treatment for advanced stage non-small cell lung cancer is limited. In an attempt to determine whether immune stimulating activity can be induced with a GMCSF gene transduced autologous tumor vaccine (GVAX), 83 patients were entered into trial (20 with stage 1B/IIB disease and 63 with stage IIIB/IV disease). Patients fulfilling eligibility criteria underwent surgical harvest of autologous lung tumor tissue. The tissue was then processed, transfected with an E1 deleted, E3 deleted adenoviral GMCSF gene vector irradiated prior to injection. Patients received a series of six vaccinations (1 every two weeks). Forty-three of the 83 patients were eligible for treatment (10 in cohort A and 33 in cohort B). These results have previously been reported. GVAX was well tolerated. Three of 33 patients with advanced disease achieved complete response. Evidence of immunologic activity following vaccination in a subset of patients was suggested, based on antibody response to either autologous SV40 transformed tumor cells or allogeneic non-small cell lung cancer tumor cells. These results supported further clinical investigation with GVAX in non-small cell lung cancer.
Insights
This study investigated the safety and immune response of a granulocyte-macrophage colony-stimulating factor (GM-CSF) gene-transduced autologous tumor vaccine (GVAX) in non-small cell lung cancer patients. GVAX demonstrated tolerability and suggested immunologic activity, supporting further clinical trials.
Area of Science:
- Oncology
- Immunotherapy
- Gene Therapy
Background:
- Advanced non-small cell lung cancer (NSCLC) has limited treatment options.
- Investigating novel immunotherapeutic strategies is crucial for improving patient outcomes.
- Granulocyte-macrophage colony-stimulating factor (GM-CSF) plays a role in immune modulation.
Purpose of the Study:
- To evaluate the safety and immunogenicity of a GM-CSF gene-transduced autologous tumor vaccine (GVAX) in patients with NSCLC.
- To assess the potential of GVAX to stimulate an anti-tumor immune response.
- To determine the feasibility of GVAX administration in a clinical trial setting.
Main Methods:
- 83 patients with NSCLC were enrolled in a clinical trial.
- Autologous tumor tissue was harvested, processed, and transduced with a GM-CSF gene vector.
- Patients received a series of six GVAX vaccinations over two weeks.
Main Results:
- GVAX was well-tolerated in eligible patients.
- Three out of 33 patients with advanced NSCLC achieved a complete response.
- Evidence of immunologic activity was observed in a subset of patients, indicated by antibody responses.
Conclusions:
- GVAX is a safe and potentially effective immunotherapy for non-small cell lung cancer.
- The observed immunologic activity supports further clinical investigation of GVAX.
- GVAX represents a promising therapeutic approach for advanced NSCLC.
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