Linvoseltamab (BCMA×CD3 bispecific) maintains ~63–74% ORR in frail RRMM patients in LINKER-MM1

Linvoseltamab is a human BCMA×CD3 T-cell–engaging bispecific antibody evaluated at the 200mg dose in the Phase 1/2, single-arm LINKER-MM1 study (NCT03761108) in heavily pretreated relapsed/refractory multiple myeloma; in this post hoc frailty subgroup analysis (data cutoff July 23, 2024; median follow-up 21.3 months), 117 treated patients were categorized as frail by IMWG Frailty Proxy (27.4%), Simplified Frailty Score (26.5%), or patient-reported frailty phenotype (20.5%). ORR was broadly similar in non-frail vs frail patients across tools: IMWG-FP 72.7% vs 65.6%, SFS 69.8% vs 74.2%, and PRFP 73.0% vs 62.5%, with Grade 3/4 TEAE rates also comparable (IMWG-FP 72.7% vs 75.0%; SFS 73.3% vs 74.2%; PRFP 74.2% vs 70.8%). In real-world US triple-class–exposed RRMM, “standard-of-care” salvage regimens typically deliver far lower response rates and shorter disease control than BCMA bispecifics; in an external-control comparison using similar eligibility criteria, linvoseltamab improved ORR (weighted odds ratio 3.0) and PFS (wHR 0.33) vs real-world SOC—suggesting these frailty data support access rather than exclusion, but without proving equivalence in survival endpoints within the frail subgroup.