Lundbaserade Alligator Bioscience fortsätter att stärka argumenten för sin fas II-kandidat mitazalimab med 24-månadersdata. BioStock pratade med vd Søren Bregenholt för att få hans kommentarer på de senaste data.
– These results align well with our expectations and further reinforce our confidence in mitazalimab’s potential, säger Bregenholt.

Alligator Bioscience, som fokuserar på att förbättra cancerbehandlingar, adderade under onsdagsmorgonen till den ström av goda nyheter som omger huvudkandidaten mitazalimab. Kandidaten, en CD40-agonistisk antikropp, har utvärderats som förstalinjesbehandling vid metastaserande pankreascancer i fas II-studien OPTIMIZE-1 i kombination med standardbehandlingen mFOLFIRINOX. Under 2024 rapporterade bolaget mycket lovande data från studien, inklusive övertygande topplinedata och 18-månaders överlevnadsdata. Läs mer här. 

24-månadersdata fortsätter att övertyga 

Efter förra årets publicering av 18-månadersresultaten släppte Alligator på onsdagsmorgonen förra veckan analysen av 24-månadersdata. Denna bekräftar en stark överlevnadsfördel och stärker mitazalimabs potential som en effektiv immunterapi. 

Studien visade att 29,4 procent av patienterna som fick mitazalimab med mFOLFIRINOX fortfarande var vid liv efter 24 månader. Detta är avsevärt högre än de uppskattade överlevnadssiffrorna på 8 procent för enbart FOLFIRINOX. Den mediana uppföljningstiden var 25,4 månader, där 16 patienter (28 procent) fortfarande var vid liv, inklusive fem (9 procent) som fortfarande får behandling. 

Den mediana totala överlevnaden (mOS) var 14,9 månader, vilket överträffar de 11,1 månader som observerats med FOLFIRINOX eller NALIRIFOX, en annan standardbehandling. Responsens varaktighet var 12,6 månader, jämfört med 5,9 och 7,3 månader för standardbehandlingar. Resultaten bekräftar att mitazalimab ger stabila och långvariga fördelar över tid. 

Vd kommenterar

Søren, what stands out as the most important data from the 24-month analysis?

– We are very pleased to see that mitzalimab continues to provide long-term survival benefits with a 29.4% survival rate at 24 months in this hard-to-treat cancer. These data are underpinned by the fact that ~10% of the patients remain on treatment at this late timepoint, where the longest ongoing treament duration is more than 32 months.

What do you see as the key factors driving the extended survival benefit compared to standard treatments?

– Published mitazalimab biomarker data show a level of correlation between activation of the patients’ immune system and clinical response. In my view the extended survival benefit is a consequence of sustained immune activation in these patients, which is supported by the fact that some of these patients are maintained on mitazalimab only, without any chemotherapy.

The 900 µg/kg dose shows significantly higher response rates than the 450 µg/kg dose. How do these findings influence your strategy for the upcoming phase III trial?

– It is important to remember that we did the 450 µg/kg cohort to satisfy FDA’s request for additional dose characterization prior to phase 3 initiation. These data confirms, together with other data, that 900 µg/kg remains the recommended phase 3 dose.

With 29% of patients still alive at 24 months and some remaining on treatment for over 32 months, what insights do these long-term outcomes provide about mitazalimab’s durability?

– As just discussed, these data suggest that mitazalimab is able to sustain the tumor-directed immune response in these patients. We are of course digging deeper into the genetic and immune profile of these patients to establish any connections.

You are currently preparing for a phase III trial and engaging with potential partners. What are the next steps in this preparatory work?

– With these data, the confirmed regulatory pathway and the ongoing phase 3 manufacturing, the program is on track for phase 3 initiation in the second half this year. Meanwhile we actively explore strategic collaborations to accelerate late-stage development of mitazalimab.

The market reacted very positively to the results. Why do you think that is?

– The entire Alligator team is of course very pleased that investors, peers, and investigators have reacted to positively to these unprecedented data and the progress we have made pushing mitazalimab forward as a transformative treatment option for pancreatic cancer. Given the strong scientific foundation and the encouraging data we have seen continuously reported from OPTIMIZE-1, we were not surprised by the positive outcome of the readout. These results align well with our expectations and further reinforce our confidence in mitazalimab’s potential.

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