- China approved belantamab mafodotin with bortezomib plus dexamethasone for adults with relapsed/refractory multiple myeloma after ≥1 prior therapy
- DREAMM‑7 randomized 494 patients (1:1); BVd nearly tripled median PFS (36.6 vs 13.4 months; HR 0.41) and cut risk of death by 42% (OS HR 0.58) at 39.4‑month median follow‑up
- Belantamab was dosed 2.5 mg/kg IV every three weeks for the first eight cycles then continued as single agent; the ADC uses monomethyl auristatin F with a Seagen‑licensed linker and an antibody produced via POTELLIGENT tech (BioWa/Kyowa Kirin)
- Key safety: thrombocytopenia 87% and diarrhea 32%; ocular adverse events were reversible with dose modifications, with ≤9% discontinuing due to eye issues
Approval
The National Medical Products Administration approved blenantamab mafodotin (Blenrep) in combination with bortezomib and dexamethasone for adults with relapsed or refractory multiple myeloma after at least one prior line of therapy following priority review and Breakthrough Therapy designation.
DREAMM‑7 key outcomes
Phase III DREAMM‑7 randomized 494 patients 1:1 to BVd versus DVd; BVd nearly tripled median PFS (36.6 vs 13.4 months; HR 0.41, p<0.00001) and reduced risk of death by 42% (OS HR 0.58) at a median follow‑up of 39.4 months, with three‑year OS rates of 74% versus 60%.
Drug profile and dosing
Blenrep is an anti‑BCMA antibody‑drug conjugate linked to monomethyl auristatin F (Seagen‑licensed linker); in DREAMM‑7 it was given 2.5 mg/kg IV every three weeks for eight combination cycles, then continued as monotherapy.
Safety and administration
Ocular adverse events were reported but described as reversible with dose modifications, yielding ≤9% discontinuations for eye issues; most common non‑ocular AEs included thrombocytopenia (87%) and diarrhea (32%); Blenrep is administered as a 30‑minute outpatient infusion.
Context
Incidence of multiple myeloma in China has risen to about 30,000 new cases annually with a 50% increase in mortality over three decades, highlighting demand for effective outpatient‑deliverable therapies.
