Aduro BioTech, Inc. announced that results from a Phase 2 clinical trial of patients with metastatic pancreatic cancer were published in the most recent issue of the Journal of Clinical Oncology(JCO). The multi-center trial, which enrolled 93 pancreatic cancer patients, demonstrated a statistically significant survival benefit in patients receiving the combination immuno-oncology regimen of CRS-207 and GVAX Pancreas. In the clinical trial, the median overall survival of Arm A patients receiving the combination regimen of CRS-207 and GVAX Pancreas was 6.1 months compared to 3.9 months for Arm B patients receiving GVAX monotherapy (HR=0.5930, one-sided p=0.0172).

One-year survival probability for patients in Arm A was 24% compared with 12% for patients in Arm B. The most frequent drug-related Grade 3 or 4 adverse event (AE) was lymphopenia, with three patients experiencing Grade 3 lymphopenia and two patients experiencing Grade 4 lymphopenia. There were no other Grade 4 AEs, and there were no other Grade 3 AEs with frequencies higher than five % in either arm. The most common Grade 3 AEs were transient lymphopenia, fevers, elevated liver enzymes and fatigue.

The trial enrolled advanced-stage metastatic pancreatic cancer patients who previously received or refused prior chemotherapy, with most patients having received two or more prior therapies in the metastatic setting. Patients were randomized in a 2:1 ratio to receive two doses of GVAX Pancreas vaccine followed by four doses of CRS-207 (Arm A) or to receive six doses of GVAX Pancreas vaccine alone (Arm B). The results were more pronounced in a pre-defined subset of patients who received at least three doses in either treatment group (GVAX Pancreas dose followed by at least one CRS-207 dose in Arm A or at least three doses of GVAX Pancreas in Arm B).

The median overall survival was 9.7 months in Arm A compared to 4.6 months in Arm B (HR=0.5290, one-sided p=0.0167).