Faron's BEXMAB update provided additional information on response duration
Summary
- Faron presented updated results from the BEXMAB Phase I/II trial, showing extended treatment response duration in HR-MDS, supporting a transition to a broader Phase IIb BEXERA trial scheduled for H2'26.
- The BEXMAB study reported an 85% Overall Response Rate and a 45% Complete Remission rate, with the median duration of CR responses increasing to 16.1 months, compared to around 10 months for azacitidine-only treatment in previous studies.
- Biological data suggests that bexmarilimab combined with azacitidine alters the bone marrow immune landscape, potentially enhancing T cell activation and healthy cell recovery more effectively than azacitidine alone.
- The company is on track to start the randomized Phase IIb BEXERA trial with 90 patients in H2'26, with results expected in Q4'27, marking key value drivers for Faron.
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Translation: Original published in Finnish on 6/16/2026 at 7:24 am EEST.
On Monday, Faron presented updated clinical results from the BEXMAB Phase I/II trial of bexmarilimab at the EHA Congress. The results indicate that treatment response duration is extended in higher-risk myelodysplastic syndrome (HR-MDS). Accumulating evidence supports the company's transition to a broader Phase IIb BEXERA trial, which is on schedule to begin in H2'26, according to the company.
New information on response duration obtained through longer-term follow-up
In the BEXMAB study, the Overall Response Rate (ORR) for the combination of bexmarilimab and azacitidine in frontline HR-MDS patients was 85%, and the Complete Remission (CR) rate was 45%. The proportion of patients who achieved full clearance of bone marrow blasts increased from the previous 55% to 60%. The median duration of CR responses increased to 16.1 months as the follow-up period extended. These results are preliminarily promising as the duration of CR responses for azacitidine-only treatment in previous studies has been around 10 months, though there has been significant study-specific volatility. In general, results from different studies are not particularly comparable, and reliable data will only be available from appropriately designed comparative studies.
CR responses are a key data point, as Faron has previously agreed with the US Food and Drug Administration (FDA) that the number of CRs is the primary endpoint of the upcoming Phase IIb trial. The newly released data further supports the drug candidate's clinical profile and paves the way for the next phase of research.
Biological data supports the mode of action and prepares for the future
In addition to the clinical results, the company presented biological research data indicating that the combination of bexmarilimab and azacitidine changes the bone marrow immune landscape. The results suggest that the treatment may activate T cells that destroy cancer cells and promote recovery of healthy cells more effectively than azacitidine alone. In addition, the company observed differences in the baseline immune profiling between patients who responded to treatment and those who did not. The company also confirmed that it is fully on track to initiate its randomized Phase IIb BEXERA trial with 90 patients in the second half of 2026. This study and its expected readout in Q4'27 are key value drivers for the company.
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