Expert: Bispecific T-cell engager binding BCMA on myeloma cells and CD3 on T-cells, inducing T-cell mediated cytotoxicity.

Everyday: A protein that directs immune cells to attack myeloma cells.

Targets: ["BCMA","CD3"]

Primary EP: [{"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"

Efficacy: 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).

Safety: 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%. D

Lynozyfic - Earlier-line MM (2L-3L) - Ph3 Enrollment 2026

BCMAxCD3 bispecific for RRMM 4L+. FDA accelerated approval July 2, 2025. Competes with teclistamab (JNJ), elranatamab (PFE), talquetamab (JNJ). LINKER-MM1: 70% ORR (including 45% CR or better). SC maintenance dosing is a convenience advantage. Too early for meaningful revenue data.

{"keyRisks":[{"category":"CRS (cytokine release syndrome)","description":"Occurred in 46%. Mostly Grade 1-2. Grade 3 <1%. Manage with tocilizumab/dexamethasone per standard protocols. Step-up dosing mitigates risk.","incidenceRate":"46%"},{"category":"Neurologic toxicity / ICANS","description":"Any neurotoxicity 54%, ICANS 8%, Grade 3-4 8%. Includes headache, tremor, confusion.","incidenceRate":"8% ICANS"},{"category":"Serious infections","description":"Occurred in 42%. Fatal infections in 4%. Profound lymphopenia (Grade 3-4 in 92%) increases infection risk. Monitor for pneumonia, COVID, opportunistic infections.","incidenceRate":"42%"},{"category":"Cytopenias","description":"Grade 3-4 neutropenia 47%, anemia 42%, lymphopenia 92%. Monitor CBCs regularly.","incidenceRate":">40%"}],"monitoring":["CRS monitoring during step-up and first doses","Neurological assessment","CBC with differential before each dose","Infection surveillance (Ig levels, viral reactivation)"],"classWarnings":["BCMAxCD3 bispecific: T-cell activation carries CRS, neurotoxicity, infection risks","Step-up dosing required to mitigate CRS","REMS program required"],"hasBoxedWarning":false}