Multinational phase 1b-2 trial of first-line mitazalimab plus mFOLFIRINOX for metastatic pancreatic ductal adenocarcinoma

Current systemic therapies for metastatic pancreatic ductal adenocarcinoma (mPDAC) are associated with a 5-year overall survival rate under 5%. The multinational phase 1b-2 OPTIMIZE-1 trial evaluated the combination of the human CD40 agonistic IgG1 antibody mitazalimab with mFOLFIRINOX as first-line treatment for mPDAC in adult patients. In phase 1b, the recommended phase 2 dose was determined to be 900 μg/kg every two weeks in combination with mFOLFIRINOX every two weeks. In phase 2, the objective response rate was 40%, meeting the primary endpoint. The authors conclude that the combination of mitazalimab and mFOLFIRINOX had manageable safety and encouraging activity as first-line treatment for mPDAC.