Abstract 5364: Correlation of immune responses and overall survival in a phase II study of belagenpumatucel-L, an allogeneic tumor cell vaccine, in non-small cell lung cancer (NSCLC)

This study examines the correlative/predictive value of cellular- and humoral-mediated immune response on the clinical responsiveness of patients who received belagenpumatucel-L, a therapeutic vaccine comprised of 4 TGF-β2 antisense gene-modified allogeneic non-small cell lung cancer (NSCLC) cell lines in a phase II clinical trial in which subjects with stage III/IV NSCLC received intradermal injections of the vaccine every 4-8 weeks. We performed assays of cellular (ELISPOT) and humoral (antibody ELISA) immunity on 36 subjects in the trial and correlated these data with the long term assessment of overall survival. All but one subject in the study showed an increase in immune reactivity in at least one of the cellular or humoral assays. Eleven subjects who demonstrated an aggregate increase in both cellular and humoral immune reactivity (positive by three of four criteria tested) had a median survival of 32.5 months (95% CI, 25.2 to 39.8). This was significantly better than the median survival of only 11.6 months (95% CI, 5.6 to 17.6) for the 25 subjects who showed an increase in one or none of the measured immune parameters (p=0.015, log-rank test). The demonstration of a statistically significant correlation between cellular and humoral immune responses and overall survival in subjects treated with belagenpumatucel-L suggest that both compartments of the immune system likely impact the clinical response and are important for the induction of clinically significant antitumor immunity by the vaccine. Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 103rd Annual Meeting of the American Association for Cancer Research; 2012 Mar 31-Apr 4; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2012;72(8 Suppl):Abstract nr 5364. doi:1538-7445.AM2012-5364