OPTIMIZE-1 is an ongoing Phase 1b/2 trial of mitazalimab in combination with mFOLFIRINOX in first-line metastatic pancreatic cancer (mPDAC). The trial has demonstrated strong clinical outcomes to date, including a ~30% survival rate at 24-months follow up.

Mitazalimab-induced biomarkers were associated with clinical benefit supporting a significant contribution of mitazalimab to clinical efficacy, including the intratumoral immune activation in responding patients. In addition, a fibrosis-related gene signature was identified as potentially predictive of improved overall survival, while ctKRAS clearance and molecular response were significantly associated with longer survival and outcomes.

These translational data strengthen the rationale for mitazalimab’s mode of action, showing that mitazalimab-induced immune activation and suppression of tumor-promoting genes contribute to the clinical benefits observed in OPTMIZE-1. With an observed median overall survival of 14.9 months and objective response rate of 54.4%, the results support further development of mitazalimab in mPDAC, including the planned randomized confirmatory trial. 

Alligator’s participation at ASCO reflects its commitment to scientific exchange and business development. The meeting provides an important platform to highlight mitazalimab’s potential and engage in strategic partnering discussions. 

Abstract information:

• Title: Biomarkers associated with outcomes from OPTIMIZE-1: CD40 agonist mitazalimab with mFOLFIRINOX in patients with untreated metastatic pancreatic cancer
• First Author: Philippe Cassier
• Date and time: 2^nd June 2025, 1.30 p.m. - 4:30 p.m CDT.
• Session Title: Developmental Therapeutics—Immunotherapy
• Sub Track: Tissue-Based Biomarkers
• Abstract Number: 2624
• Poster Board Number: 271
• Abstract link