APX005M, a CD40 monoclonal antibody, for patients with pancreatic adenocarcinoma

Despite progress, chemotherapy yields disappointing results in metastatic pancreatic ductal adenocarcinoma and median overall survival is less than 12 months. Mark H O’Hara and colleagues 1 O'Hara MH O'Reilly EM Varadhachary G et al. Evaluating the safety and efficacy of CD40 agonistic monoclonal antibody APX005M and chemotherapy, with or without nivolumab, for the treatment of metastatic pancreatic adenocarcinoma: an open-label, multicentre, phase 1b study. Lancet Oncol. 2021; 22: 118-131 Google Scholar investigated how to improve this figure by building on a nab-paclitaxel plus gemcitabine chemotherapy backbone in a phase 1b trial assessing the recommended phase 2 dose of the CD40 agonistic monoclonal antibody APX005M, with and without nivolumab, in an attempt to sensitise an immunologically cold disease. The authors provide an example of a smart strategic project of drug development and multicentre cooperation aimed at boosting and fostering the acquisition of sound and reliable data by rapid execution of a well designed and well managed trial. CD40 agonistic monoclonal antibody APX005M (sotigalimab) and chemotherapy, with or without nivolumab, for the treatment of metastatic pancreatic adenocarcinoma: an open-label, multicentre, phase 1b studyAPX005M and gemcitabine plus nab-paclitaxel, with or without nivolumab, is tolerable in metastatic pancreatic adenocarcinoma and shows clinical activity. If confirmed in later phase trials, this treatment regimen could replace chemotherapy-only standard of care in this population. Full-Text PDF