What question did this study set out to answer?

This study aims to assess the efficacy and safety of mitazalimab combined with mFFX in untreated patients with metastatic pancreatic ductal adenocarcinoma.

May 30, 2026

CD40 agonist mitazalimab + mFOLFIRINOX (mFFX) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): Final efficacy analysis of the OPTIMIZE-1 study.

Key Points

This study aims to assess the efficacy and safety of mitazalimab combined with mFFX in untreated patients with metastatic pancreatic ductal adenocarcinoma.
Open-label, single-arm, multicenter phase 1b/2 trial
Patients received mitazalimab with mFFX regimen
Primary endpoint was overall response rate (ORR) compared to historical controls
Overall response rate (ORR) was 54.4% (42.1% confirmed) among 57 evaluable patients treated with 900 µg/kg
Median overall survival (mOS) was 14.9 months with 12-month OS rate of 57.8%
Three patients achieved complete responses in target lesions, reinforcing treatment efficacy

Abstract

e16380 Background: With a 5-year overall survival (OS) rate 36 months—support continued development of mitazalimab in a confirmatory Phase 3 study. Clinical trial information: NCT04888312 . 450 µg/kg(N=22) 900 µg/kg(N=57) Median follow up (95% CI) 13.1 (12.1 - 13.9) 36.2 (30.9 - 36.7) ORR n % (90% CI) 5 (22.7) 24 (42.1) DoR (95% CI) NE (3.7 - NE) 12.6 (7.5 - 22.0) mPFS (95% CI) 5.3 (2.0 - 9.2) 7.8 (5.8 - 11.5) mOS (95% CI) 9.7 (5.9 - NE) 14.9 (10.0 - 17.3) 12-month OS, % (95% CI) 42.9 (21.9 - 62.3) 57.8 (43.9 - 69.4) 18-month OS, % (95% CI) 32.1 (11.1 – 55.7) 37.3 (24.8 - 49.9) 24-month OS, % (95% CI) - 26.1 (15.4 - 38.2) 30-month OS, % (95% CI) - 20.5 (11.0 - 32.1)

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CD40 agonist mitazalimab + mFOLFIRINOX (mFFX) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): Final efficacy analysis of the OPTIMIZE-1 study.

Key Points

Abstract

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