Lynozyfic (linvoseltamab-gcpt) / Regeneron - LARVOL DELTA

Linvoseltamab versus real-world International Myeloma Working Group standard-of-care in triple-class exposed relapsed/refractory multiple myeloma. (PubMed, Blood Cancer J) - P1/2 | "Linvoseltamab had a higher objective response rate (weighted odds ratio 3.0 [95% confidence interval (CI): 1.9-4.1]) and longer median progression-free survival (weighted hazard ratio [wHR] 0.33 [95% CI: 0.28-0.40]), time to next treatment (wHR 0.34 [95% CI: 0.29-0.44]), and overall survival (wHR 0.72 [95% CI: 0.58-0.98]) than RW SOC. These findings highlight linvoseltamab's potential as an effective treatment for 3L+ and TCE/TCR RRMM."

Journal • Real-world evidence • Hematological Malignancies • Multiple Myeloma • Oncology

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 | Sponsor: European Myeloma Network B.V.

Trial initiation date • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

Clinical predictors of cytokine release syndrome in non-single chain CD3 directed therapies among cancer patients (AACR 2026) - "20 patients were identified with median age of 67 years. 30% were male and 70% were female. 35% received tarlatamab, 30% got glofitamab, 10% got talquetamab and epcoritamab each, 1 patient got mosunetuzumab and linvoseltamab."

Clinical • Cytokine release syndrome • Oncology

Safety and efficacy of linvoseltamab as a simplified monotherapy first-line regimen in NDMM: Initial Results from the window of opportunity Phase 1/2 LINKER-MM4 trial (ASH 2025) - P1/2 | "In this larger, longer follow-up analysis, LINVO monotherapy continues to have high ORRand a generally manageable safety profile in NDMM, with no Gr ≥2 CRS events and 1 Gr 1 ICANS eventobserved. Responses may deepen over time, especially in the 200 mg cohort, supporting the furtherexploration of LINVO as a foundational drug in NDMM front-line regimens."

Clinical • Monotherapy • P1/2 data • Infectious Disease • Inflammation • Multiple Myeloma • Neutropenia • Plasmacytoma • Pneumonia • Respiratory Diseases

An interview with dr. Joshua Richter on his experience as an investigator for linvoseltamab-gcpt - by Reegan Burnell-Clarke (commissioning Editor). (PubMed, Expert Rev Hematol) - No abstract available

Interview • Journal

Patient-reported Quality of Life with Linvoseltamab in Triple-class Exposed Patients with Relapsed/refractory Multiple Myeloma: 2-year Results from the LINKER-MM1 Phase 1/2 Clinical Trial (IMS 2025) - "Improvements in pt-reported QoL, PF, pain, and fatigue were robust over 2 years of linvoseltamab treatment, complementing clinical benefits and supporting a favorable benefit–risk profile."

Clinical • HEOR • P1/2 data • Fatigue • Hematological Malignancies • Multiple Myeloma

A phase 2 trial of abbreviated fixed-duration (Default 4 Cycles) linvoseltamab immuno-consolidation to deepen responses post newly diagnosed multiple myeloma combination therapy for minimal residual disease positivity (the IMMUNOPLANT Study) (ASH 2025) - P2 | "Although high-dose melphalan with autologous stem cell transplant (HDM-ASCT)remains an option for some patients, others prefer a harvest and delayed approach...Prophylaxis includestocilizumab 8 mg/kg to prevent cytokine release syndrome (CRS) 1 hour prior to first dose,dexamethasone 40/10mg C1 only, and standard anti-microbial prophylaxis, IViG, and thromboembolismprophylaxis...As of datacut-off, 14 patients completed 4 cycles of Linvo and underwent MRD assessment with 100% (95%CI: 76.8-100%) achieving MRD negativity by both NGS clonoSEQ (10-6) and flow cytometry (10-5) (13 sCR; 1 VGPR).All patients remain alive, with no relapses and all after C4 have initiated lenalidomide-based maintenancetherapy per treating physician... Recent randomized studies of quad-therapies have shown unprecedented MRD negativeresponses (e.g. PERSEUS, ADVANCE, MIDAS) and in turn, HDM-ASCT may not confer further benefit inthese patients. Given the recent clinical success of T cell..."

Combination therapy • Minimal residual disease • P2 data • Residual disease • Cardiovascular • Cough • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Musculoskeletal Pain • Neutropenia • Respiratory Diseases

Linvoseltamab - A new fully human bispecific anti-BCMA/CD3 antibody, in multiple myeloma from the 4th line of treatment and triple-exposed (PubMed, Bull Cancer) - No abstract available

Journal • Hematological Malignancies • Multiple Myeloma • Oncology

BLOOD-dose: A Platform Trial Evaluating Dose Optimization in Hematological Diseases. (clinicaltrials.gov) - P4 | N=400 | Not yet recruiting | Sponsor: Anne Louise Tølbøll Sørensen

New P4 trial • Hematological Disorders • Hematological Malignancies • Lymphoma • Lymphoplasmacytic Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Waldenstrom Macroglobulinemia

Indirect comparison of linvoseltamab (LINVO) versus teclistamab (TEC) for triple-class exposed (TCE) relapsed/refractory multiple myeloma (RRMM): an updated matching-adjusted indirect comparison (MAIC) analysis based on 14-month follow-up data (DKK 2026) - "These results highlight the potential of LINVO as a highly effective treatment option for TCE RRMM."

Hematological Malignancies • Multiple Myeloma

The evolution of bispecific antibodies in multiple myeloma. (PubMed, Chin Clin Oncol) - "The treatment of multiple myeloma (MM) has revolutionized over the last decade with the advent of CD38-targeting monoclonal antibodies such as daratumumab and isatuximab that were integrated into the therapeutic arsenal of patients with newly diagnosed or with relapsed and/or refractory (R/R) MM...Four BsAbs-teclistamab, elranatamab, linvoseltamab, and talquetamab-are currently approved by the Food and Drug Administration (FDA) for the management of patients with R/R MM. We review in this paper the most studied BiAbs, their mechanism of action, clinical activity, the mechanism of resistance. We discuss the place of BiAbs in the therapeutic arsenal of MM and the emergence of novel strategies such as combining two classes of BiAbs (for example teclistamab and talquetamab) or novel therapies such as trispecific antibodies to overcome resistance and increase the efficacy of BiAbs."

Journal • Review • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

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) (clinicaltrialsregister.eu) - P2/3 | N=315 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals Inc.

Monotherapy • New P2/3 trial • Hematological Malignancies • Multiple Myeloma • Oncology

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 (clinicaltrialsregister.eu) - P2/3 | N=713 | Recruiting | Sponsor: European Myeloma Network B.V., Emn Trial Office S.r.l. Impresa Sociale

New P2/3 trial • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

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 | Sponsor: Regeneron Pharmaceuticals

New P2/3 trial • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

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 | Sponsor: Regeneron Pharmaceuticals

First-in-human • New P1/2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

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 | Sponsor: Fred Hutchinson Cancer Center | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

Linvoseltamab (LINVO) in patients (pts) with relapsed/refractory multiple myeloma (RRMM) in the LINKER-MM1 study: Longer follow-up (FU) and subgroup analyses (DKK 2026) - P1/2 | "ORR was 68% in pts with penta-refractory disease, and 70% in pts with prior belantamab mafodotin treatment (tx). These results support the efficacy and generally manageable safety profile of LINVO in RRMM."

Clinical • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Plasmacytoma

LINKER-MM1: Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: Regeneron Pharmaceuticals | N=74 ➔ 200

Enrollment change • First-in-human • Hematological Malignancies • Multiple Myeloma • Oncology

LINKER-MM1: Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=282 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2029 ➔ May 2030

Enrollment closed • First-in-human • Trial completion date • Hematological Malignancies • Multiple Myeloma • Oncology

LINKER-MM1: Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=74 | Recruiting | Sponsor: Regeneron Pharmaceuticals | N=56 ➔ 74

Enrollment change • First-in-human • Hematological Malignancies • Multiple Myeloma • Oncology

LINKER-MM1: Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=291 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Trial completion date: May 2025 ➔ Oct 2029 | Trial primary completion date: May 2025 ➔ May 2023

First-in-human • Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Linvoseltamab (LINVO) in frail patients (pts) with relapsed/refractory multiple myeloma (RRMM): A subgroup analysis of the LINKER-MM1 study (DKK 2026) - P1/2 | "These results suggest frail, older pts can be treated with LINVO with a similar risk–benefit profile to non-frail pts. References: 1. Facon et al."

Clinical • Hematological Malignancies • Infectious Disease • Leukemia • Multiple Myeloma

LINKER-MM1: Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=387 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Trial completion date: Jun 2032 ➔ Jun 2033 | Trial primary completion date: May 2032 ➔ Mar 2033

First-in-human • Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

LINKER-MM1: Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=309 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Trial completion date: May 2030 ➔ Mar 2032

First-in-human • Trial completion date • Hematological Malignancies • Multiple Myeloma • Oncology

LINKER-MM1: Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=56 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

First-in-human • New P1/2 trial • Hematological Malignancies • Multiple Myeloma • Oncology