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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:
7d
Determination 2 - Isatuximab, Iberdomide, Bortezomib and Dexamethasone Induction, Followed by Risk- and Response-Adapted Consolidation and Maintenance Therapy, in Transplant-Eligible Patients With Newly Diagnosed Multiple Myeloma (clinicaltrials.gov)
P3, N=720, Not yet recruiting, Dana-Farber Cancer Institute
New P3 trial
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TP53 (Tumor protein P53)
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clonoSEQ®
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bortezomib • dexamethasone • iberdomide (CC-220) • Lynozyfic (linvoseltamab-gcpt) • Sarclisa subcutaneous (isatuximab subcutaneous) • captisol-enabled melphalan
14d
POPLIN: Adult Outpatient Linvoseltamab With Tocilizumab Prophylaxis to Mitigate the Risk of Cytokine Release Syndrome (CRS) (clinicaltrials.gov)
P4, N=30, Not yet recruiting, Regeneron Pharmaceuticals
New P4 trial
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Actemra IV (tocilizumab) • Lynozyfic (linvoseltamab-gcpt)
27d
Horizon Two Adaptive Platform Study in High Risk Newly Diagnosed Multiple Myeloma (clinicaltrials.gov)
P2, N=300, Recruiting, Multiple Myeloma Research Consortium | Not yet recruiting --> Recruiting | Initiation date: Oct 2025 --> Apr 2026
Enrollment open • Trial initiation date
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SDC1 (Syndecan 1)
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TP53 mutation
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clonoSEQ®
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Sarclisa (isatuximab-irfc) • Lynozyfic (linvoseltamab-gcpt)
1m
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: Mar 2026 --> Jul 2026
Trial initiation date
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Lynozyfic (linvoseltamab-gcpt)
2ms
R17372-HM-2493: A Trial to Study if REGN17372 in Combination with Linvoseltamab is Tolerable for Adult Participants with Relapsed/Refractory Multiple Myeloma (2025-522776-93-00)
P1, N=26, Not yet recruiting, Regeneron Pharmaceuticals Inc.
New P1 trial • First-in-human
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Lynozyfic (linvoseltamab-gcpt)
2ms
Advances in multiple myeloma: key updates from the ASH 2025 meeting. (PubMed, J Hematol Oncol)
In newly diagnosed MM (NDMM), minimal residual disease (MRD)-adaptive consolidation with linvoseltamab in IMMUNOPLANT converted persistent MRD positivity to MRD negativity in all evaluable patients, supporting biologically guided treatment intensification...In early relapsed/refractory MM (RRMM), the pioneering phase III MajesTEC-3 trial demonstrated significant progression-free survival (PFS) and overall survival (OS) benefits with BsAb teclistamab plus daratumumab compared to other standard triplets, with response rates approaching those historically observed with chimeric antigen receptor (CAR) T cell therapy. A novel rational BsAb combination of BsAb elranatamab anda cereblon E3 ligase modulatory drug (CELMoD) iberdomide in MagnetisMM-30 showed promising synergy despite cytopenias and updates to combination BsAb targeting in RedirecTT-1 demonstrated major activity in difficult to treat extramedullary myeloma (EMM). First-in-human inMMyCAR data showcased the forefront of engineered immune strategies, by introducing an in vivo CAR-T product as a proof-of-concept platform, with tremendous potential to streamline the access to therapy. Collectively, these studies signal a shift toward earlier and adaptive immunotherapy in all phases of MM disease, while underscoring the importance of infection mitigation and long-term safety evaluation.
Journal • First-in-human
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CRBN (Cereblon)
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Darzalex (daratumumab) • Elrexfio (elranatamab-bcmm) • Tecvayli (teclistamab-cqyv) • iberdomide (CC-220) • Lynozyfic (linvoseltamab-gcpt)
2ms
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
Trial initiation date
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bortezomib • carfilzomib • dexamethasone • pomalidomide • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Lynozyfic (linvoseltamab-gcpt)
2ms
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, Recruiting, Regeneron Pharmaceuticals | Not yet recruiting --> Recruiting
Enrollment open • First-in-human
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Lynozyfic (linvoseltamab-gcpt)
3ms
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)
3ms
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
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Lynozyfic (linvoseltamab-gcpt)
3ms
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
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Lynozyfic (linvoseltamab-gcpt)
4ms
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
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lenalidomide • bortezomib • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • Lynozyfic (linvoseltamab-gcpt)
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