Studien utvärderar Alligator Biosciences CD40-agonist mitazalimab i kombination med mFOLFIRINOX hos patienter med metastaserad pankreatisk duktal adenokarcinom (mPDAC).
Den kommande posterpresentationen omfattar 24-månadersdata kring effekt och doskarakterisering, med fokus på lovande överlevnadsresultat och en tydlig dos-responsrelation.
Positiva överlevnad- och responssiffror
Patienter som behandlats med den högre dosen av mitazalimab (900 μg/kg) uppnådde en medianöverlevnad på 14,9 månader och en median progressionsfri överlevnad på 7,8 månader. 24-månadersöverlevnaden nådde 29,4 procent – en betydande förbättring jämfört med enbart cellgiftsbehandling.
En jämförelse mellan de två doskohorterna visade en avsevärt högre objektiv responssiffra i gruppen som fick 900 μg/kg (54,4 procent) jämfört med gruppen som fick 450 μg/kg (22,7 procent). Dessa resultat tyder på en dosberoende effekt och understryker mitazalimabs potential att förbättra behandlingsresultaten för patienter med få behandlingsalternativ och dålig prognos.
Baserat på dessa data har 900 μg/kg mitazalimab rekommenderats som dos för fas III-studier – ett beslut som nyligen fått stöd av FDA.
Posterpresentation på ESMO
Resultaten kommer att presenteras på ESMO GI torsdagen den 3 juli 2025 av Dr. Aurélien under titeln:
CD40 agonist mitazalimab + mFOLFIRINOX in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): 24-month follow up and dose characterisation from the OPTIMIZE-1 study
Kommentar från vd
BioStock pratade med vd Søren Bregenholt för en djupare inblick i de nya resultaten från OPTIMIZE-1-studien.
How do you interpret the 24-month survival data from OPTIMIZE-1 in the context of current treatment standards for metastatic pancreatic cancer?
– We are very encouraged by the 24-month survival data from OPTIMIZE-1 that we are now presenting at ESMO GI. With these results, mitazalimab continues to demonstrate long-term clinical benefit in this highly aggressive cancer. The results are particularly notable given that the current standard treatments typically result in considerably lower long-term survival. The fact that around 10 per cent of patients in OPTIMIZE-1 remain on treatment beyond two years, with the longest treatment duration now exceeding 3 years at the time of writing, underscores the durability of the response and mitazalimab’s potential to change the treatment landscape for mPDAC.
– In addition to the clinical data itself, we are equally proud and encouraged by patient stories about how mitazalimab has enabled them to reduce or stop chemotherapy, improved their quality of life, and allowed them more valuable time with their family and loved ones.
What key messages or insights are you aiming to highlight at ESMO GI 2025?
– The primary focus at ESMO GI is to share the maturing survival and dose characterisation data, which continue to support mitazalimab’s development. As you may recall, in December 2023, FDA requested us to provide additional data from the 450 µg/kg dose cohort. In less than 18 months, we have managed to treat an additional 17 patients, readout and analyse data and present them to the FDA with a successful outcome. This is a strong testament to the dedication and professionalism of the Alligator team, our collaborators, and investigators.
– The data clearly show a dose-dependent effect, with the 900 µg/kg group achieving more than double the objective response rate compared to the 450 µg/kg group. This data is further supported by a so-called exposure-response analysis, together reinforcing the selection of 900 µg/kg as the recommended phase III dose – which as you know was recently endorsed by the FDA and EMA. We also aim to highlight the consistency of the survival benefit and the immune-driven mode of action, which we believe are key differentiators for mitazalimab in the treatment of metastatic pancreatic cancer.
Finally, how are preparations for the phase III trial with mitazalimab progressing?
– The preparations are progressing according to plan. In addition to the regulatory dialogue, we have manufactured the drug to be used in the trial, using an updated commercial manufacturing process. Hence, we are well-positioned to initiate the pivotal trial and we are actively engaging with potential partners to explore strategic collaborations that could further accelerate mitazalimab’s late-stage development and broaden its clinical and commercial potential.
