Novel Tumor Vaccine Gp96-Ig Fusion Heat Shock Protein In Advanced Non-Small Cell Lung Cancer (Nsclc) Patients Who Have Failed Palliative Chemotherapy And Erlotinib

e18042 Background: To determine the safety, immunogenicity, and clinical response to our newly developed allogeneic gp96-Ig tumor vaccine for NSCLC patients (pts) with advanced disease who have failed standard chemotherapy and erlotinib. Methods: Allogeneic, cultured lung adenocarcinoma cells transfected with HLA A1 and gp96-Ig were irradiated and injected intradermally into pts suffering from advanced, relapsed, or metastatic NSCLC in a phase I clinical trial. HLA matching was not required. Three dose-schedule combinations were considered (total of 4.5 × 107 cells administered by 9 biweekly (DS1), 18 weekly (DS2), or 36 twice weekly (DS3) injections). We planned to enroll a maximum of 36 patients. Immune response to vaccination of patients was measured by determining adenocarcinoma-specific CD8 CTL frequencies in ELI-spot assays for interferon-γ (IFN-γ) and by measuring the frequency of FoxP3+ CD4+ Treg. If pts had a clinical response, defined as complete (CR), partial (PR), or stable disease (SD), they continued with the next course of vaccinations for up to 3 courses (9 - 36 vaccinations total). Results: 14 patients were consented, one was never treated due to early progression and another other one was found to be a screen failure. Median age was 65 (38-86), 8/12 were female, most of them Hispanic. Most of the patients had failed at least 2 lines of chemotherapy and erlotinib. 9 patients were treated in DS1 cohort, two in DS2 and one in DS3. None of the patients experienced serious adverse events (SAE) that were related to vaccine. Grade I: rash, skin induration and skin erythema were seen in 5/12/12 patients respectively. Two patients had SD, one for more than 6 months. Four pts (including the 2 pts that had SD) had an immunological response determined by ELI-spot, and in most of the patients the frequency of FoxP3+ CD4+ Treg decreased. Conclusions: Minimal toxicity and immunologic response has been seen so far in this very advanced population of NSCLC pts. No significant financial relationships to disclose.