Bexmarilimab (Clever-1 macrophage checkpoint) + azacitidine logs 80% ORR and 13.4-mo OS in relapsed high-risk MDS

Bexmarilimab, an antibody that blocks the macrophage/blast checkpoint Clever-1, was combined with standard azacitidine in the phase 1/2 BEXMAB trial (NCT05428969). In 35 hypomethylating-agent–refractory MDS patients, overall response reached 80% by IWG 2006 (65% by IWG 2023) with a median overall survival of 13.4 months; the small frontline cohort (n = 5) posted 100% ORR. No dose-limiting toxicities emerged across 1–6 mg/kg weekly doses; only three grade 3 treatment-related events (pruritus, rash, malaise) were seen, and discontinuations were rare (2.5%). For context, azacitidine alone achieves ~16% complete remissions and median OS < 6 months after HMA failure, underscoring the magnitude of benefit if the signal holds.

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