[{"id":"mm1-orr","name":"Overall Response Rate (ORR)","type":"PRIMARY","unit":"%","results":[{"notes":"70% ORR (95% CI 59-80%). sCR 39%, CR 6%, VGPR 19%, PR 6%. CR or better: 45%.","value":70,"arm_id":"linvoseltamab-mm1","arm_name":"Linvoseltamab 200mg","ci_lower":59,"ci_upper":80}],"timepoint":"Best response","description":"Proportion of patients achieving partial response or better (PR, VGPR, CR, sCR) per IMWG criteria. Single-arm trial in heavily pretreated RRMM (≥4 prior lines including PI, IMiD, anti-CD38)."}]

LINKER-MM1: 70% ORR (95% CI 59-80%) with 45% CR or better in heavily pretreated RRMM (median 5 prior lines). Median DOR not reached at data cutoff (72% at 12 months). Rapid responses (median time to first response <1 month).

LINKER-MM1 (n=117): CRS 46% (mostly Grade 1-2, Grade 3 <1%). Neurotoxicity 54% (ICANS 8%, Grade 3-4 8%). Serious infections 42% (fatal 4%). Grade 3-4 neutropenia 47%, lymphopenia 92%. Pneumonia 28%. Discontinuation 16%. SAEs 74%. Typical bispecific T-cell engager safety profile.

LINKER-MM1 is competitive: 70% ORR and 45% deep response (CR+) in 5L+ patients. The step-up dosing mitigates CRS (<1% Grade 3). SC maintenance after step-up is a convenience advantage vs all-IV competitors. The 72% 12-month DOR is encouraging. Key risk: serious infection rate (42%) and fatal infections (4%) — class-wide concern with T-cell redirecting therapies.

BCMAxCD3 bispecific redirects T-cells to kill BCMA-expressing myeloma cells. BCMA is highly expressed on MM cells.