Positive mitazalimab trial results in pancreatic cancer

Swedish immuno-oncology company Alligator Bioscience (Nasdaq Stockholm: ATORX) today announced positive top-line results from the OPTIMIZE-1 Phase II study of the company’s lead asset mitazalimab in first line metastatic pancreatic cancer, with the news pushing the company’s shares up a signification 28% to 1.51 kronor.

The open-label, multicenter study assessed the safety and efficacy of mitazalimab (CD40 MAb agonist) in combination with standard of care chemotherapy mFOLFIRINOX, in previously untreated, chemotherapy naive patients.

The study achieved its primary endpoint with the top-line results demonstrating a confirmed Objective Response Rate (ORR) of 40.4%, an unconfirmed ORR of 50.9% and a disease control rate (DCR) of 79% in 57 evaluable patients, as per the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). This compares favorably to the ORR of 31.6% reported in a similar patient population treated with FOLFIRINOX alon.e.