G17DT+gemcitabine [Gem] versus placebo+Gem in untreated subjects with locally advanced, recurrent, or metastatic adenocarcinoma of the pancreas: Results of a randomized, double-blind, multinational, multicenter study

Abstract

LBA4012 Background: G17DT is a novel immunotherapeutic targeted at the gastrin-17 tumor growth factor. It was shown to be effective as monotherapy in advanced pancreatic cancer [APC] (Gilliam et al, ASCO 2004 Abstract 2511) and has also shown encouraging efficacy in Phase 2 trials in combination with chemotherapy in gastric (Michaeli et al, ASCO 2004 Abstract 4048) and colorectal cancer (Rocha Lima et al, ASCO 2004 Abstract 3573). In this study, the combination of G17DT+Gem was investigated in patients with APC. Methods: This was a randomized, double-blind study in subjects with intact organ function, KPS≥70, and evaluable or measurable disease. Subjects were randomized 1:1 to G17DT+Gem or identical matching placebo+Gem in two strata (disease stage II+III vs IV). G17DT/placebo was administered im at wk 0, 4, 8 and 24; Gem (1 g/m2 according to the package insert) was administered to subjects in both arms. 180 deaths per arm would provide 80% power to detect a hazard ratio of 0.744 with α = 0.048. Results: 394 subjects were randomized, with 369 deaths included in this analysis. Data analysis is taking place in January - February 2005. Results of the analyses of the primary endpoint, survival, and of secondary endpoints (tumor response, time to disease progression, and relationship between anti-G17 antibody responder status and efficacy endpoints), as well as of safety analyses, will be presented. Conclusions: TBD Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aphton Aphton Aphton