A randomized, placebo-controlled, double blind, multicenter phase II adjuvant trial of the efficacy, immunogenicity, and safety of GI-4000 plus gem versus gem alone in patients with resected pancreas cancer with activating RAS mutations/survival and immunology analysis of the R1 subgroup.

e14501 Background: Patients with resected pancreas cancer treated with standard of care Gem have a median overall survival of 22 months (vs 20 months w/ observation). Activating mutations in ras occur in > 90% of pancreas cancer cases. GI-4000 is whole, heat-killed recombinant S. cerevisiae yeast that expresses mutated Ras proteins. This trial is designed to evaluate the efficacy, immunogenicity, and safety of GI-4000 plus Gem in patients with Ras mutant + resected pancreas cancer. Methods: The study enrolled 176 Ras mutant + pancreas cancer subjects post resection randomized 1:1 to GI-4000 plus Gem or placebo plus Gem (stratified by resection status; R0 or R1). Three weekly injections of GI-4000 or placebo were followed by 6 cycles of Gem 1000 mg/m2 iv (day 1, 8, 15 every 28 days). Monthly GI-4000 or placebo were administered on the Gem off-weeks and continued monthly until intolerance, disease recurrence, or death. The primary endpoint is RFS. Data for the 39 R1 subjects (GI-4000 n=19, Placebo n=20) hav...