Single-center phase 1-2 study of LOAd703 plus chemotherapy for unresectable or metastatic pancreatic cancer

Pancreatic ductal adenocarcinoma is characterized by low immunogenicity and an immunosuppressive tumor microenvironment. LOAd703 is an oncolytic adenovirus that lyses cancer cells selectively, activates cytotoxic T cells, and induces tumor regression in preclinical models. Arm 1 of the phase 1-2 study LOKON001, at Baylor College of Medicine (Houston, TX), evaluated the combination of LOAd703 with nab-paclitaxel and gemcitabine chemotherapy for advanced pancreatic ductal adenocarcinoma (aPDAC). The combination was feasible and safe, and resulted in increased proportion of CD8⁺ effector memory cells and adenovirus-specific T-cells after LOAd703 injections in 94% of patients. Among the patients evaluable for activity, 44% (95% CI 26-66) had an objective response. Arm 2 of the study, combining LOAd703 with nab-paclitaxel plus gemcitabine and atezolizumab, is ongoing.