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our Premium Content: News alerts, weekly reports and conference plannersDRUG:
Lynozyfic (linvoseltamab-gcpt)
i
Other names: REGN5458, REGN 5458, BCMAxCD3 antibody, BCMAxCD3 bispecific antibody
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News alerts, weekly reports and conference planners
Company:
Regeneron
Drug class:
CD3 agonist, BCMA inhibitor
Related drugs:
13d
EMN39: A Study to Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant (clinicaltrials.gov)
P3, N=1000, Recruiting, European Myeloma Network B.V.
Trial initiation date
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lenalidomide • Darzalex (daratumumab) • dexamethasone • Lynozyfic (linvoseltamab-gcpt)
1m
A Trial to Study if REGN17372 in Combination With Linvoseltamab is Tolerable for Adult Participants With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
P1/2, N=150, Not yet recruiting, Regeneron Pharmaceuticals
New P1/2 trial • First-in-human
|
Lynozyfic (linvoseltamab-gcpt)
1m
Response-Based Dose Reduction of Linvoseltamab in the Treatment of Relapsed, Refractory, or Triple-Class Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
P1/2, N=30, Recruiting, Fred Hutchinson Cancer Center | Not yet recruiting --> Recruiting
Enrollment open
|
Lynozyfic (linvoseltamab-gcpt)
1m
LINKER-MM8: A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM) (clinicaltrials.gov)
P2/3, N=1570, Not yet recruiting, Regeneron Pharmaceuticals
New P2/3 trial
|
lenalidomide • bortezomib • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Lynozyfic (linvoseltamab-gcpt)
1m
LINKER-SMM1: A Proof-of-Concept Trial to Study the Safety and Activity of Linvoseltamab in Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma (clinicaltrials.gov)
P2, N=40, Active, not recruiting, Regeneron Pharmaceuticals | Recruiting --> Active, not recruiting
Enrollment closed
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Lynozyfic (linvoseltamab-gcpt)
2ms
EMN39: A Randomized, Open-Label, Controlled Phase 3 Study Comparing Daratumumab, Lenalidomide and Dexamethasone Induction followed by Linvoseltamab Versus continued Daratumumab, Lenalidomide, and Dexamethasone in Newly Diagnosed Transplant Ineligible Multiple Myeloma Patients (2024-519827-16-00)
P2/3, N=713, Recruiting, European Myeloma Network B.V., Emn Trial Office S.r.l. Impresa Sociale
New P2/3 trial
|
lenalidomide • Darzalex (daratumumab) • dexamethasone • Lynozyfic (linvoseltamab-gcpt)
2ms
R5458-ONC-2246: A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy with Standard-of-Care Combination Regimens in Adult Participants with Relapsed/Refractory Multiple Myeloma (RRMM) (2024-519504-27-00)
P2/3, N=315, Not yet recruiting, Regeneron Pharmaceuticals Inc.
New P2/3 trial
|
bortezomib • Darzalex (daratumumab) • carfilzomib • dexamethasone • pomalidomide • Lynozyfic (linvoseltamab-gcpt)
2ms
LINKER-SMM2: A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM) (clinicaltrials.gov)
P3, N=270, Not yet recruiting, Regeneron Pharmaceuticals
New P3 trial
|
Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Lynozyfic (linvoseltamab-gcpt)
2ms
BCMA Bispecific Antibody Therapy for Post-BCMA CAR T-Cell Therapy Relapse (RECLAIM) (clinicaltrials.gov)
P2, N=34, Not yet recruiting, Medical College of Wisconsin | Initiation date: Dec 2025 --> Mar 2026
Trial initiation date
|
Lynozyfic (linvoseltamab-gcpt)
3ms
LINKER-MM5: A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (clinicaltrials.gov)
P3, N=915, Recruiting, Regeneron Pharmaceuticals | Not yet recruiting --> Recruiting
Enrollment open
|
bortezomib • carfilzomib • dexamethasone • pomalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Lynozyfic (linvoseltamab-gcpt)
3ms
BCMA biology and therapeutic targeting in multiple myeloma: From ligand signaling to antigen escape. (PubMed, Semin Hematol)
We then summarize the clinical development and distinguishing features of currently approved BCMA-targeted modalities-CAR T-cell therapies (ide-cel, cilta-cel), bispecific T-cell engagers (teclistamab, elranatamab, linvoseltamab), and the antibody-drug conjugate (belantamab mafodotin)-highlighting their efficacy, toxicity profiles, and practical positioning in relapsed/refractory MM. Finally, we review emerging resistance mechanisms, including γ-secretase-driven sBCMA elevation, ligand-rich APRIL/BAFF niches, and therapy-induced TNFRSF17 lesions, ranging from biallelic deletions to epitope-altering missense mutations and in-frame deletions within the BCMA extracellular domain. These insights inform rational strategies such as γ-secretase inhibition, dual-target CAR T-cells and bispecific T-cell engagers.
Journal • IO biomarker
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TNFRSF17 (TNF Receptor Superfamily Member 17)
|
Elrexfio (elranatamab-bcmm) • Blenrep (belantamab mafodotin-blmf) • Abecma (idecabtagene vicleucel) • Carvykti (ciltacabtagene autoleucel) • Tecvayli (teclistamab-cqyv) • Lynozyfic (linvoseltamab-gcpt)
4ms
EMN39: A Study to Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant (clinicaltrials.gov)
P3, N=1000, Recruiting, European Myeloma Network B.V. | Not yet recruiting --> Recruiting
Enrollment open
|
lenalidomide • Darzalex (daratumumab) • dexamethasone • Lynozyfic (linvoseltamab-gcpt)
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