The publication, titled “CD40 agonist mitazalimab with mFOLFIRINOX in untreated metastatic pancreatic cancer: biomarkers associated with outcomes from OPTIMIZE-1”, provides mechanistic insights into determinants of clinical response and offers translational support for a planned randomized Phase 3 trial.

Key findings from the publication include:

• Clinical efficacy: The OPTIMIZE-1 study met its primary endpoint, with a confirmed objective response rate of 42.1% in the Phase 2 cohort. Median duration of response was 12.6 months, progression-free survival 7.7 months, and overall survival 14.9 months. The survival rate at 24 months was 29.4%, triple that of chemotherapy alone.
• Tumor gene signature linked to outcome: Baseline expression of a tumor-intrinsic fibrotic gene signature, directly linked to the mode of action of mitazalimab, was associated with improved overall survival.
• Peripheral immune activation: Mitazalimab-induced increases in circulating activated immune cells correlated with better clinical outcomes.
• Intratumoral immune activation: Patients with objective clinical responses displayed mitazalimab-induced immune activation supporting mitazalimab’s contribution to clinical outcomes
• Translational impact: strongly supports mitazalimabs contribution to the improved clinical outcomes observed in OPTIMIZE-1 and supports future development of predictive biomarkers for mitazalimab.

“These data provide important guidance for understanding which patients may benefit most from mitazalimab-based immunotherapy in pancreatic cancer, and provides further evidence for mitazalimab’s contribution to the sustained clinical benefit observed in the OPTIMIZE-1 trial” said Søren Bregenholt, CEO of Alligator Bioscience. “The integration of biomarker-driven insights into our clinical development strategy strengthens the foundation for the next phase of mitazalimab’s evaluation in this high-need indication.”

The full article is available online through >>this link<<.