Efficacy of GV1001 with gemcitabine/capecitabine in previously untreated patients with advanced pancreatic ductal adenocarcinoma having high serum eotaxin levels (KG4/2015): an open-label, randomized, phase 3 trial.

The TeloVac study indicated that GV1001 did not to improve the survival of advanced pancreatic ductal adenocarcinoma (PDAC) patients. However, the cytokine examinations of the study suggested that high serum eotaxin levels may predict responses to GV1001. This phase III trial aimed to assess the efficacy of GV1001 with gemcitabine/capecitabine for eotaxin-high patients with untreated locally advanced and metastatic PDAC. In addition, we proposed potential blood markers to predict response to GV1001 treatment based on correlative studies. To determine potential markers to predict chemoresponse to GV1001, patients’ samples at the time of pretreatment were analyzed using antibody microarray analysis. According to survival, good responders and poor responders were selected from the GV1001 and control groups to compare the difference of marker expression by patients’ treatment response. A total of 73 patients’ samples were analyzed; 49 samples from the GV1001 group (22 good responders and 27 poor responders) and 24 samples from the control group (13 good responders and 11 poor responders). [Sample title header- GV1001 group: GG, control group: CG, good responder: GR, poor responder: PR]