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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.
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.
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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