Alligator Bioscience To Present Positive Phase 2 Mitazalimab Data in Pancreatic Cancer at 2024 ASCO Annual Meeting
In This Article:
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OPTIMIZE-1 study results showed confirmed ORR of 40.4%, unconfirmed ORR of 50.9% and DCR of 79% in 57 evaluable patients with chemotherapy-na?ve mPDAC
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The encouraging duration of response (median 12.5 months) and overall survival (median 14.3 months) support continued development of mitazalimab in a randomized confirmatory Phase 3 trial
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Biomarker analysis demonstrates correlation of mitazalimab-induced immune activation with clinical outcomes
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Updated results from a longer, 18-month survival follow-up in OPTIMIZE-1 expected at end of June 2024
LUND, SWEDEN / ACCESSWIRE / May 23, 2024 / Alligator Bioscience (STO:ATORX) today announced that two clinical abstracts on its lead drug candidate mitazalimab, a best-in-class CD40 agonist, in first line metastatic pancreatic cancer will be presented (abstracts 2569 and 4133) in a poster presentation session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago, IL and online during May 31-June 4.
Data presented at ASCO from the OPTIMIZE-1 study, of mitazalimab in combination with mFOLFIRINOX chemotherapy, showed that pharmacological analyses identified mitazalimab-induced expansion of CD4 effector T cells one week after first administration as a correlate of treatment outcomes. These data suggest the contribution of mitazalimab to tumor responses, and further supports the unique trial design of OPTIMIZE-1.
OPTIMIZE-1 achieved its primary endpoint, demonstrating a confirmed Objective Response Rate (ORR) of 40.4%, an unconfirmed ORR of 50.9% and a disease control rate (DCR) of 79% in 57 evaluable patients, as per the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). This compares favorably to the ORR of 31.6% reported in a similar patient population treated with FOLFIRINOX alone.[1] Median Duration of Response (DoR) was 12.5 months, remarkably longer than reported so far with any other approved and investigational therapies. Median Overall Survival (OS) was 14.3 months and the survival estimate from the next planned analysis may further improve.
"Most pancreatic cancer patients are diagnosed after the disease has already metastasized. Treatment options at this stage are rather unsatisfactory and there is a major need of novel therapies for these patients. The primary analysis results of OPTIMIZE-1 study suggest that adding mitazalimab to the modified FOLFIRINOX regimen significantly prolongs the durability of response, resulting in a meaningful extension of overall survival in this fatal disease. It is indeed encouraging to see many patients still continuing in the study, and we are very much looking forward to the 18-month survival follow-up from OPTIMIZE-1, which we expect at the end of June 2024," said Dr. Sumeet Ambarkhane, CMO of Alligator Bioscience. "These results support the continued development of mitazalimab in combination with mFOLFIRINOX, in a confirmatory, phase 3, clinical trial in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC). Furthermore, the correlation of mitazalimab-induced immune activation with improved clinical outcomes suggests a potential immunological profile that could be used as a biomarker for this treatment."
