EHA 2025 | Results of the BEXMAB study: efficacy of bexmarilimab plus azacitidine in MDS

This is actually a trial that we are presenting here in Milan. Bexmarilimab is a novel macrophage activator and we are investigating that in both frontline and relapsed resistant MDS patient population. CLEVER-1 is an immunosuppressive molecule that is expressed on monocytes and Bexmarilimab actually targets this CLEVER-1 molecule. And based on the inhibition caused by bexmarilimab, the monocytes become more immunologically active ones. So they are secreting more cytokines, they are overexpressing antigen-presenting molecules, and most importantly, they are activating T-cells. 

We are presenting the data from both frontline and HMA failed patient population. In frontline we had 21 MDS patients and in HMA failure patient population we had 32 patients. In both patient populations the patients were receiving the combination of azacitidine plus bexmarilimab. In the Phase I part of the trial we did a dose escalation with three dose levels: one, three and six milligrams per kilogram. We did not observe dose-limiting toxicities and in general the toxicity profile was very similar to standard of care. 

Our patient population was quite difficult to treat. Over 40% of the patients had TP53 mutations and actually also most patients had a very high risk as per IPSS-R. Regarding the responses for previously untreated MDS patients the overall response rate was 55% as per 2023 classification and for HMA failed patient population that was 47%. When looking at overall survival which we have ready for HMA failure patient population the overall survival was 13.4 months for the whole patient population. For TP53 mutated patient population overall survival median was 9.4 months. 

So taken together at least this far the data looks extremely promising and we are currently planning for the Phase III trial in newly diagnosed MDS population.

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