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Purpose: To determine the safety, immunogenicity, and clinical response to an allogeneic tumor vaccine for NSCLC, we conducted a phase 1 trial in patients (pts) with advanced metastatic disease. Material and Methods: We treated 19 pts with a vaccine based on adenocarcinoma line (AD100) transfected with B7.1 (CD80) and HLA A1 or A2. Pts were vaccinated intradermally with 5x107 cells once every two weeks. Three such vaccinations represented one course of treatment. If pts had a clinical response, defined by protocol as complete (CR), partial (PR), or stable disease (SD), they continued with the next course of vaccinations for up to 3 courses (9 vaccinations total). Immune response was assessed by a change between pre-study and post-vaccination Elispot frequency of purified CD8 T cells secreting Ifn-γ in response to in vitro challenge with AD100. Results: All pts had advanced metastatic disease. Most were white (13/19), female (12/19), and had already failed palliative chemotherapy (17/19), and radiotherapy (6/19). Adenocarcinomas predominated (11/19). A total of 90 vaccinations were given to the 19 patients. Four pts experienced serious adverse events that were judged to be unrelated to vaccine: two-pericardial effusions, one renal failure, and one respiratory failure. Another 4 pts experienced only minimal skin erythema. All but one pt had a measurable CD8 response after 6 weeks (3 immunizations). The immune response of six surviving and clinically responding pts shows that CD8 titers continue to be elevated up to 150 weeks even after cessation of vaccination. Overall, one pt had a partial response (5%), and five had stable disease (26%). The median survival for all pts is estimated at 18 months with corresponding estimates of 1–year and 2-year overall survival of: 52% (90% CI: 32 to 73%) and 30% (90% CI: 10 to 50%), respectively. HLA matching, age, sex, race, or pathology did not have a significant relation to clinical response. Conclusion: Minimal toxicity and good survival in this initial investigation suggest clinical benefit from vaccination.

[Proc Amer Assoc Cancer Res, Volume 45, 2004]