ASCO 2024: Alligator Reports Positive Pancreatic Cancer Drug Data

Alligator Bioscience has shared promising results from its Phase Ib/II OPTIMIZE-1 study (NCT04888312) on mitazalimab, a monoclonal antibody therapy aimed at treating pancreatic cancer. The data, presented at the American Society of Clinical Oncology Annual Meeting (ASCO 2024) and published in Lancet Oncology on June 3, suggests that mitazalimab, when used in combination with the chemotherapy regimen mFOLFIRINOX, offers significant improvements over traditional therapies.

According to the study findings, patients treated with the mitazalimab and mFOLFIRINOX combination saw a confirmed objective response rate (ORR) of 40.4% and a median overall survival (mOS) of 14.3 months. These results are notably better than historical data for mFOLFIRINOX alone, which typically shows an ORR of 31.6% and an mOS of 11.1 months.

In an exclusive discussion with Pharmaceutical Technology, Alligator Bioscience’s CEO, Dr. Søren Bregenholt, emphasized the importance of these findings. "Adding three months to overall survival is clinically significant," he said. "It is meaningful for patients and is a differential that can be approved in almost all major territories." Bregenholt points out that chemotherapy remains the primary treatment for approximately 80% of pancreatic cancer patients, both as a frontline and second-line option. However, existing approved therapies are considered mediocre in terms of their response rates and clinical benefits.

In February 2024, the US Food and Drug Administration (FDA) approved Ipsen Biopharmaceuticals' combination chemotherapy regimen NALIRIFOX for the first-line treatment of pancreatic cancer. This regimen incorporates Onivyde (irinotecan liposome) along with oxaliplatin, fluorouracil, and leucovorin. NALIRIFOX is only the second Onivyde-based regimen to receive FDA approval for metastatic pancreatic adenocarcinoma, following FOLFIRINOX's approval more than a decade ago. Dr. Bregenholt highlighted that mitazalimab has fewer adverse reactions and side effects compared to the widely used chemotherapy combinations.

Mitazalimab functions as a CD40 agonist, targeting pancreatic cancer by activating and proliferating memory T cells, thereby enhancing the immune response. The encouraging data from the Phase Ib/II study has led Alligator Bioscience to plan a Phase III trial for mitazalimab. "We expect to start the Phase III trial in the first half of next year," Bregenholt confirmed.

The company’s focus on mitazalimab reflects its commitment to advancing treatments for pancreatic cancer, which remains one of the most challenging cancers to treat. The improvements in survival and response rates presented in the Phase Ib/II study offer hope for better therapeutic options in the future. Alligator Bioscience’s ongoing efforts and forthcoming Phase III trial will determine whether mitazalimab can become a new standard of care for pancreatic cancer patients, potentially altering the treatment landscape for this difficult disease.

Overall, the emerging data underscores the potential of mitazalimab to offer considerable benefits over current chemotherapy treatments, providing a glimmer of hope for patients and healthcare providers seeking more effective solutions for pancreatic cancer.