Faron leukemia trial results continue on positive trajectory

Translation: Original published in Finnish on 11/28/2024 at 7:31 am EET.

On Wednesday, Faron announced key interim results from the Phase II BEXMAB trial. Key results have now been reported in a press release and more detailed results will be presented at the ASH meeting on December 9 and at a subsequent press conference, which can be viewed here on December 10. The results have continued to be positive and are in line with previous read-outs. We will update our view on the stock after the press conference.

Patient enrollment has progressed according to plan

According to the press release, 20/32 patients with myelodysplastic syndrome (MDS) who no longer respond to HMA (relapsed/refractory MDS, r/r MDS) have been analyzed to date in Phase I and II. Since the summer, the trial has been on track and the company has confirmed earlier information that patient enrollment will be completed in January 2025. The result read-out for all patients should be completed by the end of Q1'25. However, we estimate that responses will continue to be monitored beyond this time and that results relevant to the operation of the drug candidate should also be available in summer 2025 and later time points. In addition to r/r MDS patients, the study includes first-line MDS patients, for whom bexmarilimab is being studied as part of their first-line treatment. The press release did not comment on these patients. This is likely due to the small number of patients treated at this stage.

Responses are still seen in the vast majority of patients

At this stage, the overall response rate (ORR) is 80% (16/20) of patients treated. This is excellent as a single figure. However, it should be noted that the quality of the responses plays a key role in the interpretation of the results and no further information on quality was available at this stage. The estimated life expectancy of patients was 13.4 months, in line with previous results. In previous studies, life expectancy with standard treatment (azacitidine) has been 5-6 months. We remind you that direct comparisons of figures can easily lead to erroneous conclusions, as there may be differences in, e.g., patient selection between studies, which may reduce comparability at this stage.

More detailed information will be available in a couple of weeks

A more detailed analysis of the results will be presented at the annual meeting of the American Society of Hematology (ASH) in San Diego on December 9. Faron will hold a press conference on December 10 at 4:00 pm EET, which can be viewed here. In our view, the results release did not contain any major surprises. However, the continuation of the positive trend of the previous results will contribute to a slight reduction of the risk for the success of Phase II and may improve Faron's position in future collaboration negotiations. Our interpretation of the press release is therefore positive at this stage. We will update our view on the stock after the press conference.