Combination of platinum standard first front line chemotherapy and Vaxira vaccine in patients with advanced non- small- cell lung cancer (LALCA 2014) - Aug 12, 2014 - Abstract #PD.2; P1, N=20; “Median survival was 12.94 months. The combination was safe since the vaccination did not add toxic effects to the first lines of oncospecific therapy. All patients developed high antibody responses against Racotumomab MAb during the vaccination schedule.”
P1 data • Non Small Cell Lung Cancer • Oncology
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6th Latin American Conference on Lung Cancer, Aug 21 - 23 2014, Lima, Peru
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Background: The combination of vaccines and chemotherapy holds promise for cancer therapy, but the effect of cytotoxic chemotherapy on vaccine-induced antitumor immunity is unknown. Vaxira is a therapeutic vaccine that induces an immune response against Neu- Gc containing gangliosides sulfatides and others antigens expressed in several tumors. Vaxira is composed by Racotumomab and aluminum hydroxide as adyuvant. Racotumomab is an antiidiotype murine monoclonal antibody specific to P3 Ab1 MAb, an antibody which reacts to NeuGc-containing gangliosides, sulfatides and other antigens expressed in tumors. Phase I trials conducted in patients with advanced melanoma, breast and lung cancer have demonstrated the low toxicity and high immunogenicity of Vaxira.
Methods: An exploratory phase I study was conducted to assess the feasibility of combining Vaxira vaccine with the standard first line chemotherapy used in advanced NSCLC patients and determine the effect on Racotumomab-specific humoral immune responses. Twenty patients with histological confirmed NSCLC stages IIIB/IV were treated with cisplatin/vinblastine as standard first front line therapy according the treatment established in the Oncology Therapeutic Guidelines. Vaccination schedule consisted in the administration of 1mg of Racotumomab by intradermic route. The first 5 doses were administered every 14 days concomitantly with the first line chemotherapy and the rest every 28 days. Vaccination was not interrupted due to disease progression, and continued until death or deterioration of PS. Humoral immune responses against Racotumomab anti-idiotype and NeuGcGM3 antigen were measured by standard ELISA assays, and changes in lymphocyte cells subpopulations were measured by flow cytometry analyses (FACS).
Results: The distribution by clinical stage at inclusion was: 8 in stage IIIB, 12 in stage IV. The combination (CT plus vaccine) responses were evaluated according the RECIST Criteria, and 19 patient achieved control disease. The 20 patients were included in an evaluation of survival (Kaplan Meier estimate), after a follow up of at least 10 months. Median survival was 12.94 months. The combination was safe since the vaccination did not add toxic effects to the first lines of oncospecific therapy. All patients developed high antibody responses against Racotumomab MAb during the vaccination schedule. IgM and IgG antibody specific response against NeuGcGM3 antigen was obtained, as in the standard not concomitant vaccination schedule used in other clinical trial protocols. Moreover, an early onset kinetics IgG isotype antibody response specifically for NeuGcGM3 was detected
Conclusion: The combination of Vaxira vaccine and systemic platinum chemotherapy has an acceptable safety profile. The present data suggest that chemotherapy does not inhibit Vaxira vaccine-mediated immune response and provide further support for evaluating novel combinations of chemotherapy and Vaxira vaccine for NSCLC and other cancers.
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