On March 14, 2023 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that it hosted a Key Opinion Leader (KOL) Interview on the interim efficacy results from the OPTIMIZE-1 Phase 2 trial of the company’s lead asset mitazalimab in 1st line metastatic pancreatic cancer, which will be available to view online from Tuesday 14 March, 2023 via this link (Press release, Alligator Bioscience, MAR 14, 2023, View Source [SID1234628633]).
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The discussion features Professor Jean-Luc Van Laethem, Head of the Digestive Oncology Clinic in the Gastroenterology Department of Erasmus Hospital (ULB) Brussels, an internationally-recognized specialist in the field of digestive cancers and the Principal Investigator of the OPTIMIZE-1 trial, and Dr. Sumeet Ambarkhane, Chief Medical Officer of Alligator Bioscience. They discuss perspectives on the current standard of care for patients with metastatic pancreatic cancer, what outcomes are associated with those therapies and the unmet medical needs. The function of mitazalimab and the OPTIMIZE-1 study design are elucidated, and the latest interim efficacy and safety data are presented and explained. Mitazalimab’s therapeutic potential, and other potential combinations with the drug candidate, are discussed as well.
OPTIMIZE-1 is an open-label, multi-center study assessing the safety and efficacy of mitazalimab (CD40 mAb) in combination with chemotherapy, mFOLFIRINOX, in previously untreated patients with metastatic pancreatic ductal adenocarcinoma. In January 2023, Alligator announced strong interim results from OPTIMIZE-1, in which mitazalimab combined with mFOLFIRINOX demonstrated an objective response rate (ORR) of 52% in 23 evaluable patients, as per the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Primary endpoint readout is expected in Q1 2024.
"The potential of mitazalimab as a combination therapy for pancreatic cancer can be seen by comparing these interim results to data from a similar patient population treated only with FOLFIRINIOX, which demonstrated an ORR of around 32 percent," said Dr. Sumeet Ambarkhane, CMO of Alligator Bioscience. "Pancreatic cancer is considered an immunologically cold tumor, meaning there is little influx of T cells which renders therapeutic approaches such as chemotherapy alone less effective. Mitazalimab has an important role to play here because it can activate better infiltration of T cells converting the tumor microenvironment from immune suppressive to immune active, to support the killing of tumor cells."