Randomised, double blind, placebo-controlled, multi-centre, group-sequential trial of G17DT for patients with advanced pancreatic cancer unsuitable or unwilling to take chemotherapy

Abstract

2511 Background: Pancreatic adenocarcinomas express CCK-2 receptors and respond to amidated gastrins resulting in transcriptional activation of EGF receptor ligands, matrix metalloproteinases and anti-apoptotic factors which collectively increase tumorigenic potential. The gastrin gene may also be activated resulting in gly-gastrin secretion. G17DT, a gastrin immunogen, induces neutralising antibodies against amidated and glycine-extended gastrin-17. Methods: Randomised, double blind, placebo-controlled, multi-centre trial of patients with advanced pancreatic cancer unsuitable or unwilling to take chemotherapy, performed outside the US. Inclusion criteria were Karnofsky performance score (KPS) ≥60, life expectancy >2 months. Patients received G17DT or the vehicle only at weeks 0, 1, 3, 24 and 52. Primary endpoint was survival; secondary endpoints included tolerability, KPS, weight change, quality of life and tumour response. Results: 154 patients: 79 randomised to G17DT, 75 to placebo. Intention to Treat (ITT) analysis gave median survival of 151 vs 82 days, G17DT:placebo, (p=0.03, Log rank). Time to deterioration of Karnofsky index was longer in the G17DT group than placebo: median 138 (95% CI: 84–165) vs 78 days (95% CI: 56–97) (p=0.038, Wilcoxon). G17DT was well tolerated; 2/79 (2.5%) G17DT patients vs 0/74 (0%) placebo patients developed sterile abscess at the injection site. Conclusion: G17DT prolongs survival, maintains performance and provides a well tolerated new therapeutic option for advanced pancreatic cancer patients. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aphton Corp. Aphton Corp. Aphton Corporation