Faron reports first OS results from frontline MDS patients
Summary
- Faron released the first overall survival (OS) analysis from the BEXMAB trial for frontline high-risk myelodysplastic syndrome (HR-MDS) patients, showing median OS reached only in the bi-allelic TP53 mutation subgroup.
- The trial's small size and lack of randomization or control group limit the strength of conclusions, with historical OS for HR-MDS patients treated with azacitidine alone serving as a benchmark.
- The BEXERA trial, a 90-patient randomized Phase IIb study, is central to Faron's investment story, with results expected in late 2027 to assess the commercial potential of bexmarilimab.
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Translation: Original published in Finnish on 7/28/2026 at 8:15 am EEST.
On Monday, Faron published the first overall survival (OS) analysis of the BEXMAB trial. The analysis concerns frontline patients with high-risk myelodysplastic syndrome (HR-MDS). According to early-stage results, median OS has only been achieved in one subgroup. In the other two subgroups, median OS has not yet been reached, and follow-up is still ongoing. In the big picture, key to the investment story is the rapid progress of the upcoming BEXERA trial towards the readout planned for the end of 2027.
OS in line with standard of care for the most urgently treated patient group
The BEXMAB trial includes 21 frontline HR-MDS patients. To our understanding, the median overall survival has not yet been reached in the entire group after a median follow-up of 14.9 months. The median was also not reached in patients with wild-type (non-mutated) TP53 gene or only one allele TP53 mutation (i.e. mutation in only one DNA strand). The only group that reached the median overall survival (8.8 months) was the patient group with bi-allelic TP53 mutations, whose disease is the most severe and prognosis the poorest. The result is in line with historical life expectancy (Bernard, 2020). Thus, the result does not suggest that bexmarilimab increases life expectancy in this subgroup. For other groups, the median has not yet been reached, so the results cannot be interpreted at this time. We emphasize that the trial design (small size, no randomization or control group) does not allow for drawing strong conclusions. Due to the small size of the entire trial, and especially the subgroups, the role of chance in the results is very significant. Historically, the OS of HR-MDS patients has varied across trials. According to a recent meta-analysis (Hasegawa, 2023), the OS of HR-MDS patients treated with azacitidine alone was 16.4 months, which serves as a rough benchmark for the efficacy of current treatment. However, direct comparisons between different trials are problematic, as we have often stated in our comments. High-quality data will be obtained from the randomized and controlled BEXERA trial, which compares the combination of bexmarilimab and azacitidine to standard-of-care (azacitidine alone).
High-quality data expected from the BEXERA trial next year
The core of Faron's investment story and the most significant value driver is the BEXERA trial. This 90-patient randomized Phase IIb trial is planned to begin in the second half of 2026. We are keenly following the broader BEXMAB data promised for the end of the year, but we estimate that the actual assessment of the drug candidate's commercial potential will only be available when the results of the BEXERA trial are completed in late 2027.