On July 1, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX) Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immunotherapies, reported that new data from the ongoing OPTIMIZE-1 study, evaluating the CD40 agonist mitazalimab in combination with mFOLFIRINOX in metastatic pancreatic cancer, will be presented at the ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2025, taking place in Barcelona on 2–5 July (Press release, Alligator Bioscience, JUL 1, 2025, View Source [SID1234654190]).
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The poster includes 24-month efficacy results and dose characterization data from OPTIMIZE-1 (NCT04888312), a Phase 1b/2 trial in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC). Patients receiving 900 μg/kg mitazalimab showed a median overall survival of 14.9 months and a median progression-free survival of 7.8 months, supporting a sustained clinical benefit. The survival rate at 24 months was 29.4%, triple that of chemotherapy alone.
A comparison between the 900 μg/kg and 450 μg/kg cohorts revealed a higher response rate for 900 μg/kg of 54.4% versus 22.7%. This indicates a dose-response relationship further supporting mitazalimab’s contribution to the positive clinical response data observed in OPTIMIZE-1, reinforcing the candidate’s favorable safety profile and supporting 900 μg/kg as the recommended Phase 3 dose — a decision recently endorsed by the FDA.
Poster presentation details
Title: CD40 agonist mitazalimab + mFOLFIRINOX in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): 24-month follow up and dose characterization from the OPTIMIZE-1 study
Topic: Upper digestive – Biliary, ampullary and pancreatic cancer
Presentation number: 265P
Session: Poster display session 1 and coffee break
Date: Thursday, 3 July 2025
Time: 15:30–16:30 CEST
Location: Foyer
Presenter: Dr. Aurélien Lambert