Correlation of interferon-g (IFN-γ) response with survival in a phase II hyperacute (HAL) immunotherapy trial for non-small cell lung cancer (NSCLC).

2571 Background: Lung cancer is the leading cause of cancer-related mortality. Patients progressing after initial systemic therapy have a poor prognosis. Thus, new therapies are needed. HAL immunotherapy exploits the hyperacute rejection of a xenotransplant as defense mechanism to initiate anti-tumor immune response by administering genetically modified allogeneic tumor cells expressing the αGal moieties on their cell surface. HAL immunotherapy utilizes αGal epitopes and natural human antibodies (Ab) against these targets as the proposed mechanism for anti-tumor immunity. Methods: We completed a phase II study of HAL immunotherapy in patients with metastatic or recurrent NSCLC, age ≥18, ECOG PS ≤2, ≤2 prior systemic therapies. Trial objectives were to determine response rate, safety and immunological responses. Patients received 300 x 106 HAL cells every 2 weeks for 8 doses. Response was determined using RECIST and adverse events were assessed using CTCAE v3. Immune responses were assessed by changes in s...