Faron Pharmaceuticals Oy has released additional positive data from the Phase 1 part of the BEXMAB study, focusing on higher-risk myelodysplastic syndrome (MDS) patients who have failed on previous hypomethylating agent (HMA) treatment, as well as patients with relapsed or refractory acute myeloid leukemia (AML). The latest readout of the study shows promising results, with a high overall response rate and good durability of remission among HR HMA-failed MDS patients.
The initial Phase 1 HR HMA-failed MDS patients have shown encouraging results, with 4 out of 5 patients still alive after eight months of follow-up. While the precise estimation of median overall survival is not yet available, the survival benefit seen with the current follow-up for these patients is very encouraging and compares favorably to contemporary comparators.
The BEXMAB trial has now moved into Phase 2 for HR MDS patients failed on previous HMA treatment. The majority of the initial Phase 1 patients have been on treatment with bexmarilimab together with azacitidine for more than six months, and only one patient has been lost due to transformation of their HR MDS into AML. Out of the initial 5 patients, 4 remain alive after eight months, indicating a potentially significantly higher median overall survival than traditionally seen with current standard of care.
In addition to the initial 5 patients, 3 new HMA-failed HR MDS patients were enrolled, with 2 out of 3 responders, bringing the overall response rate to 87.5% in this population. The best responses for these 8 patients include complete response, marrow complete remissions, partial response, hematological improvements, and stable disease.
Dr. Markku Jalkanen, Chief Executive Officer of Faron, expressed confidence in the potential of bexmarilimab to considerably improve outcomes for patients suffering from these aggressive conditions. The company is eagerly awaiting completion of the Phase 2 part of the BEXMAB study to take the data to the FDA as soon as possible.
Faron will be hosting a virtual webinar to discuss the additional data, providing an opportunity for questions during the webcast. The company is also planning to run a registrational trial with median overall survival as the endpoint, based on the encouraging data from the BEXMAB study.