Abstract #LB-157: Exploratory Analysis of Gender and Age Aspects in a Finished Placebo-Controlled Randomized Trial with the Cancer Vaccine IGN101 in 762 NSCLC Patients in the Adjuvant Setting

AACR Annual Meeting-- Apr 18-22, 2009; Denver, CO IGN101 is a cancer vaccine acting via the Epithelial Cell Adhesion Molecule (EpCAM) frequently expressed on epithelial cancers. It consists of 0.5 mg alum-adsorbed murine Mab 17-1A that bears EpCAM mimotopes to trigger an anti-EpCAM immune response by repeated s.c. injections (AACR 2007). In a randomized, placebo-controlled double-blind trial 762 NSCLC pts stage Ib, II and IIIa following R0 resection were repeatedly vaccinated with placebo or IGN101, primary endpoint was relapse-free survival (RFS), no other treatment was permitted. The study analysis revealed no difference in RFS between treatment groups. However, as result of a prospectively defined subgroup analysis, patients with neutrophil and lymphocyte counts at baseline below 5x10E9/L and 1,6x10E9/L resp. had significantly improved RFS when treated with IGN101. Vaccinations were very well tolerated, no systemic side effects were observed (ASCO 2008). Here we report recent exploratory analyses of this randomized NSCLC study regarding gender and age. 604 male and 158 female patients were enrolled into this study. For the whole study population (regardless of treatment with IGN101 or placebo), there was no difference in RFS between males and females, however, a significantly improved overall survival of female patients was observed (HR 0,735; p=0,03). When comparing IGN101 and placebo, there was no difference in RFS for male patients, however, interestingly in female patients treated with IGN101 a trend to improved RFS was seen (HR 0,758; p=0,23). For the whole study population, there was no difference in RFS between different age groups (33-56, 57-67, > 67). When comparing IGN101 and placebo, there was no difference in RFS in age groups 33-56 and 57-67. However, patients with an age > 67 (n=169) showed a trend to improved RFS when treated with IGN101 (HR 0,734; p=0,16). In summary, repeated vaccination of adjuvant NSCLC patients with the cancer vaccine IGN101 may have a positive impact on RFS in female patients and in older patients. IGN101 therefore may become a very well tolerated alternative to toxic chemotherapy regimens for patients who do not tolerate such a treatment. Additional properly designed studies to assess age and gender parameters are required to substantiate these results. Citation Information: In: Proc Am Assoc Cancer Res; 2009 Apr 18-22; Denver, CO. Philadelphia (PA): AACR; 2009. Abstract nr LB-157.