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NewsA bispecific antibody called linvoseltamab is turning heads in the myeloma world. Updated phase 2 data from the LINKER-SMM1 trial show a 100% objective response rate and universal MRD negativity in patients with high-risk smoldering multiple myeloma — with no disease progression observed. A phase 3 trial comparing it to the current standard, daratumumab, is now enrolling.
A bispecific antibody is making a strong case for early intervention in myeloma. Updated data from the phase 2 LINKER-SMM1 trial show that single-agent, fixed-duration linvoseltamab (Lynozyfic) achieved a 100% objective response rate in patients with high-risk smoldering multiple myeloma (HR-SMM), with 97% reaching a very good partial response or better and 85% achieving a complete response. Crucially, no patients progressed to active multiple myeloma during the study period.
The MRD results were equally striking — every MRD-evaluable patient achieved MRD negativity at the 10⁻⁵ sensitivity threshold, and 86% hit the deeper 10⁻⁶ level at the 12-month mark. Responses continued to deepen over time, and the safety profile was considered manageable, with no cases of the serious neurological side effect ICANS reported.
By the Numbers
Why it matters: Daratumumab is currently the only approved therapy for smoldering myeloma, but its CR rate is low (~8.8%). Linvoseltamab's deep response and MRD-negativity data suggest it could redefine early intervention — and a head-to-head phase 3 trial (LINKER-SMM2) against daratumumab is now underway.
