The multi-centre, open-label Phase II trial is designed to evaluate the efficacy and safety of mitazalimab (CD40 mAb) along with chemotherapy, mFOLFIRINOX, in previously untreated metastatic pancreatic ductal adenocarcinoma patients.
Under this pre-planned interim analysis for futility, the company stated that the participating investigators and independent experts evaluated the data for probability of a positive study at primary completion.
The interim results showed that an approximately 52% objective response rate (ORR) was observed in 23 evaluable patients.
The findings demonstrated a disease control rate of over 90%, which is the proportion of patients with objective response or disease stabilisation.
Alligator Bioscience said that the interim data confirms the safety of the mitazalimab and mFOLFIRINOX combination that was previously reported in the Phase Ib dose escalation phase of the trial.
In the Phase 1b dose escalation phase, the combination of mitazalimab and mFOLFIRINOX was found to be safe and well tolerated at the recommended 900μg/kg dose.
The company intends to discuss these positive results with the regulatory authorities of Europe and the US to explore potential accelerated development and approval pathways for mitazalimab.
Alligator Bioscience CEO Søren Bregenholt said: “We are thrilled with these interim results, which demonstrate that mitazalimab combined with chemotherapy could offer a significant clinical benefit for pancreatic cancer patients over standard of care.
“We are very keen to progress our lead asset through the next stage of its development as quickly as we can, and we look forward to discussing with regulatory authorities the potential accelerated development and approval pathway for mitazalimab in pancreatic cancer.
“These strong interim data reconfirm out commitment to mitazalimab and supports broadening the mitazalimab clinical development program in additional tumour types.”
The company expects to obtain top-line data from this trial in the first quarter of next year.