Bexmarilimab–A Promising New Drug To Treat MDS, Currently in Clinical Trials

The FDA recently announced that relapsed or refractory MDS has responded well enough in the Phase 1 trial of bexmarilimab, that the advancement to Phase 2 will begin in Finland and the U.S. Bexmarilimab is a novel anti-Clever-1 antibody (expressed on malignant blasts of the bone marrow. Treatment of these cells with bexmarilimab alone or in combination with azacitidine or venetoclax results in increased activation markers on affected T cells.)

From The Beginning 

Preliminary data has shown that bexmarilimab is well tolerated with disease control rates up 40%. “Data from the Phase 1 part of the study have demonstrated that optimal target engagement can be achieved with 3 mg/kg dosing. The highest immune activation, as observed in the accumulation of activated immune cells in patients’ bone marrow, was observed in both 3 mg/kg and 6 mg/kg cohorts. Both dose levels have been safe and well tolerated to date.”

Moving Forward

Phase 2 of the BEXMAB trial (NCT05428969) will enroll 32 patients where HMAs (hypomethylating agents) have failed previously. This phase hopes to successfully treat intermediate to high-risk MDS patients. The primary goals are safety and tolerability at each dose escalation phase.

“Targeting macrophages to break the immune tolerance of tumors and help activate host immune defenses is the next cutting edge in cancer immunotherapy. Macrophage-targeted therapies could be used as monotherapy or along with various other treatments and open entirely new therapeutic options.” As a Clever-1 antibody, bexmarilimab shows anti-tumor activity as it targets macrophages. Bexmarilimab is also used alongside standard-of-care treatment for MDS.

Some of the side effects experienced with bexmarilimab:

• Fatigue- 41%
• Anemia- 25%
• Abdominal pain- 24%

Promising Future

“With current treatments, only 5% of patients with higher-risk MDS end up eligible for hematopoietic stem cell transplantation (HSCT), which intends to reset a patient’s immune system, increasing survival outcomes. The five-year survival rates for MDS between 2012 and 2018 were 36.9%, respectively.”

Bexmarilimab offers an effective treatment option for MDS patients with limited choices. “The highest overall response rate (ORR) of 80% was observed among the previously failed HMA MDS group. The bexmarilimab / SoC (standard of care) combination continues to be well-tolerated at all tested dose levels with no dose-limiting toxicities.”

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