Mitazalimab in Advanced Pancreatic Cancer

The combination of the precision cancer medicine mitazalimab and FOLFIRINOX produced responses in patients with metastatic pancreatic ductal adenocarcinoma according to updated data from the ongoing phase 2 OPTIMIZE-1 clinical trial.¹

About Mitazalimab

Mitazalimab is a precision cancer medicine known as a monoclonal antibody that targets the CD40 antigen expressed on pancreatic cancer cells and is being developed by Alligator Bioscience. In May 2023, mitazalimab received an orphan drug designation from the FDA for use as a potential therapeutic option in patients with pancreatic cancer.³

The OPTIMIZE clinical trial has been evaluating previously untreated patients with metastatic pancreatic cancer. Mitazalimab is given intravenously once every 14 days in combination with mFOLFIRINOX. An interim analysis conducted for all evaluable patients reported a response rate of 44%. Additionally, 33% of patients experienced stable disease, resulting in a disease control rate of 77%. The median duration of response was 8.7 months.^1-5

A second interim analysis of the ongoing trial reported the combination produced an objective response rate of 57% in 23 evaluable patients. Among 13 responders, 7 patients (54%) were receiving ongoing treatment for more than 10 months, with 1 patient receiving treatment for 17 months^.2

• Other drugs in development for pancreatic cancer.

References

1. https://alligatorbioscience.se/en/news/alligator-bioscience-announces-positive-second-interim-efficacy-analysis
2.  https://alligatorbioscience.se/en/news/alligator-bioscience-announces-positive-interim-result
3. https://alligatorbioscience.se/en/news/alligator-bioscience-receives-fda-orphan-drug-designation-for-mitazalimab-in-pancreatic-cancer/
4. Safety and efficacy of mitazalimab in combination with chemotherapy in pancreatic cancer patients (OPTIMIZE-1). ClinicalTrials.gov. Updated April 24, 2023. Accessed June 27, 2023. https://clinicaltrials.gov/ct2/show/NCT04888312
5. Prenen H, Borbath I, Geboes KP, et al. Efficacy and safety of mitazalimab in combination with mFOLFIRINOX in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): an interim analysis of the optimize-1 phase 1b/2 study. J Clin Oncol. 2023;41(suppl 16):4139. doi:10.1200/JCO.2023.41.16_suppl.4139