- Top-line readout demonstrates Objective Response Rate of 40.4%, meeting primary endpoint and confirming the benefit of mitazalimab in combination with mFOLFIRINOX
- Median Overall Survival of 14.3 months at the time of analysis, and expected to improve further as more than half of the patients remain alive
- Median Duration of Response of 12.5 months compares favorably to the standard of care FOLFIRINOX of 5.9 months
- Discussions with the FDA confirm a clear approval pathway with Phase 3 registration study on track to start in early 2025
Webcast to discuss top-line data with Key Opinion Leader Dr.
The study achieved its primary endpoint with the top-line results 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]
The cut-off time for analysis was
- Median Overall Survival (mOS) of 14.3 months at the time of analysis and expected to improve as majority of the patients remain alive, comparing favorably to the 11.1 months demonstrated by FOLFIRINOX[1], and more recently by NALIRIFOX in the
NAPOLI 3 Phase 3 trial[2] - An unprecedented median Duration of Response (DoR) of 12.5 months, compared to 5.9 months with FOLFIRINOX[1], and the 7.3 months demonstrated by NALIRIFOX[2]
- The 12-month survival rate was 59.3% compared to 48.1% for FOLFIRINOX[1] and 45.6% for NALIRIFOX[2]
- Median Progression Free Survival (PFS) of 7.7 months, compared to 6.4 months with FOLFIRINOX[1], and the 7.4 months demonstrated by NALIRIFOX[2]
- Mitazalimab's manageable safety and tolerability profile supporting long-term administration in combination with mFOLFIRINOX was confirmed
As the majority of patients remain alive at the time of analysis, Overall Survival and Durability of Response are expected to improve further with ongoing treatment and follow-up.
"We are very pleased to announce that the OPTIMIZE-1 study has successfully met its primary endpoint, with the data demonstrating that when combined with mFOLFIRINOX, mitazalimab provides significant survival benefit to pancreatic cancer patients compared to the standard of care," said Søren Bregenholt, CEO ofAlligator Bioscience . “The unprecedented duration of response is to us a clear confirmation of the strong immune activation that mitazalimab triggers, which translates into a much improved overall survival. As of today, more than half of the patients are still in the study and we expect these promising data to improve even further."
"It is very rewarding for us to see the OPTIMIZE-1 top-line results demonstrate the clear clinical signal and survival benefit of mitazalimab in combination with mFOLFIRINOX," said Prof.Jean-Luc van Laethem , Head of theDigestive Oncology Clinic in the Gastroenterology Department ofErasmus Hospital (ULB)Brussels and Principal Investigator of the OPTIMIZE-1 trial. "Metastatic pancreatic cancer is particularly hard to treat due to its highly complex and aggressive nature, so for mitazalimab to have delivered such data in previously untreated patients is a remarkable and promising outcome.“
"Successfully meeting its primary endpoint, together with a very long durability of response and median overall survival, is a highly encouraging result for the OPTIMIZE-1 study, which demonstrates mitazalimab's potential in pancreatic cancer," said Dr.Zev Wainberg , Professor of Medicine atUniversity of California, Los Angeles (UCLA) and co-director of the UCLA Gastrointestinal (GI) Oncology Program. “With current therapeutic options so limited, I remain highly optimistic that mitazalimab can have a significant impact on the way pancreatic cancer is treated and I look forward to the next stage of its clinical development. These data also warrant a broader evaluation of mitazalimab in other tumor types."
Phase 3 expected to start in early 2025
Mitazalimab has been granted orphan drug designation in pancreatic cancer by both FDA and the
Webcast – Monday
A webcast will be held today,
Please use the following link to connect to the webcast via Alligator’s Youtube channel.
[1] Conroy et al., N Engl J Med 2011; 364:1817-1825; DOI: 10.1056/NEJMoa1011923
[2] Wainberg et al.,
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