Abstract
7210 Background: During the last 9 years, numerous clinical trials have been conducted testing an Epidermal Growth Factor (EGF) active immunotherapy approach in patients with advanced NSCLC. This approach consists of human EGF linked to a carrier protein and administered in an adjuvant. Specifically, the vaccine is composed of human recombinant EGF conjugated to Neisseria meningitides P64K as carrier protein and emulsified in Montanide ISA51. Here, we report partial results from an open label, randomized Phase II trial designed to test immunogenicity, safety and efficacy of the EGF vaccine. Methods: Two groups of unresectable, stage IIIb or IV NSCLC patients were compared. All patients received first line chemotherapy and were then randomized to receive EGF vaccine (Group 1) or best supportive care (Group 2). Each dose contained 50ug EGF administered on days 0, 7, 14, 21, 51 and then monthly. Sera anti-EGF antibody titers as well as plasma EGF concentration [EGF] were measured monthly. Survival was compared between treatment groups. Results: Sixty nine (69%) of vaccinated patients (Group 1) showed seroconversion defined as antibody titer levels at least 2X baseline, while 23% of controls (Group 2) did. Forty five percent (45%) of vaccinated patients had a good antibody response (at least 4X baseline levels and at least 1:4000 sera dilution) while none of the controls did. The geometric mean of maximal antibody titers in Group 1 was 1: 2756 and 1:316 in Group 2. Mean minimal [EGF] was 20 pcg/ml for Group 1 and 60 pcg/ml for Group 2. No serious adverse events were reported. Vaccinated patients survived significantly longer than controls. Group 1 median overall survival was 8.47 months (mean 11.52 months) while Group 2 median overall survival was 4.33 months (mean 7.41 months) (p=0.028). Conclusions: Vaccination with EGF active immunotherapy was safe, immunogenic, and significantly increased survival of advanced NSCLC patients in this study. Further study of this approach is warranted. No significant financial relationships to disclose.
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