The ongoing P-II study (OPTIMIZE-1) evaluating mitazalimab in combination with CT (mFOLFIRINOX) in patients with mPDAC. The results are expected in Q1’24
The results showed an ORR of 52% in pre-planned interim efficacy analysis among 23 evaluable patients as per the response evaluation criteria in solid tumors (RECIST 1.1), DCR, ORR, or stabilization of disease was ≥90%
Mitazalimab was safe and tolerable at 900µg/kg in combination with mFOLFIRINOX, as previously reported in the P-Ib dose escalation phase of the trial. The company intends to talk with regulators in the EU & EU about these positive results to explore a potential accelerated development and approval pathway for mitazalimab
Ref: Alligator Bioscience | Image: Alligator Bioscience
