Lynozyfic (linvoseltamab-gcpt) / Regeneron - LARVOL DELTA

Updated Safety and Efficacy Results for Linvoseltamab (LINVO) in Patients (Pts) with High-Risk Smoldering Multiple Myeloma (HR-SMM): Phase 2 LINKER-SMM1 Trial (IMS 2026) - P2 | "With additional enrollment and follow-up ( n=36; median 8.6 mos ) in LINKER-SMM1, LINVO monotherapy continued to demonstrate deep and ongoing response s (100% ORR, 97% ≥ VGPR, 69% ≥CR) with a tolerable safety profile , support ing its role as a promising treatment strategy for HR- SMM. Further updated data as of May 2026 will be presented at the meeting. A P hase 3 registrational study is ongoing."

Clinical • P2 data • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Smoldering Multiple Myeloma

Systematic Review and Meta-Analysis of Tocilizumab Prophylaxis for Cytokine Release Syndrome (CRS) in Bispecific Antibody Therapy for Multiple Myeloma (IMS 2026) - "Databases (PubMed, Cochrane, Embase, Google Scholar) and ClinicalTrials.gov were searched with MeSH terms and keywords for tocilizumab, prophylaxis, CRS, bispecific, teclistamab, talquetamab, elranatamab, linvoseltamab, cevostamab, and multiple myeloma. A single prophylactic dose of tocilizumab before the first step-up dose consistently and substantially reduces CRS — to a pooled 9% with almost absence of grade ≥3 events. This low rate of CRS with prophylactic tocilizumab could lend to safe adoption of bispecifics in academic and community practices."

Bispecific • Cytokine release syndrome • Retrospective data • Review • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Neutropenia

Pharmacodynamic Immune Changes and Cell Type Correlates of Response, Cytokine Release Syndrome (CRS), and Infection Across Linvoseltamab (LINVO) Combination Regimens in RRMM (LINKER-MM2) (IMS 2026) - P1 | "Introduction: L INVO (BCMA×CD3) in combination with anti-CD38 m onoclonal antibodies ( m Abs ) , proteasome inhibitors (PIs), immunomodulatory drugs ( IMiDs ) , immune checkpoint inhibitors ( ICIs ) , and a gamma secretase inhibitor ( nirogacestat ) i s being evaluated in relapsed/refractory multiple myeloma ( RRMM ; LINKER-MM2; NCT05137054 ). LINVO combinations induce diverse T-cell activation patterns, including cytotoxic effector, differentiated, and senescent cells, with distinct features per regimen. Response was associated with more cytotoxic CD8 EM/EMRA prior to treatment; suppressive Tregs and CD4 ⁺ T-cell dysfunction characterized nonresponse."

Cytokine release syndrome • PK/PD data • Infectious Disease • Inflammation • Multiple Myeloma • B3GAT1 • CD27 • CD28 • CD8 • CXCL8 • ICOS • IFNG • IL10 • IL2 • KLRG1 • PD-1 • TNFA

Incidence and Timing of Cytokine Release Syndrome (CRS) Observed with Linvoseltamab (LINVO) in LINKER-MM1 in Patients (Pts) with Relapsed/Refractory Multiple Myeloma (RRMM) (IMS 2026) - P1/2 | "In Weeks 1 and 2, an optimized dosing regimen included premedication (no tocilizumab prophylaxis) and step-up dosing to mitigate CRS risk, with 24-hour inpatient monitoring after each step-up dose. CRS occurred early following LINVO administration, was primarily low grade, and decreased in frequency and severity across step-up dosing, with few higher-grade CRS events at later dosing levels. This detailed analysis enables optimization of administration and implementation of timely monitoring and interventions to improve pt safety."

Clinical • Cytokine release syndrome • Hematological Malignancies • Hypotension • Inflammation • Multiple Myeloma

Eosinophilia Associated with Elranatamab in Patients with Multiple Myeloma: A Multi-Institutional Analysis (IMS 2026) - " We retrospectively evaluated multiple myeloma patients treated with elranatamab (elra; n=181), teclistamab (tec; n=138), and linvoseltamab (linvo; n=44) as monotherapy across three academic centers (n=363)... Prophylactic medications, including sulfamethoxazole/trimethoprim, were standard across institutions and BCMA TCE products... Elra demonstrated a distinct eosinophilic toxicity profile among BCMA-TCE, characterized by higher incidence, greater severity, and infrequent but severe systemic inflammatory manifestations often independent of rash and generally not meeting criteria for DRESS. While the mechanism is unknown, recognition of this syndrome is clinically important. Continued elra dosing with corticosteroids in asymptomatic and/or low-grade cases appears feasible and effective."

Clinical • Eosinophilia • Gastrointestinal Disorder • Hematological Malignancies • Multiple Myeloma • Myeloproliferative Neoplasm

Efficacy and Safety of Linvoseltamab with Utilization of Outpatient Step-Up Dosing and Prophylactic Tocilizumab (IMS 2026) - "This is the largest cohort of RRMM patients treated with linvo to date in the real-world setting particularly with incorporation of outpatient step-up dosing and prophylactic tocilizumab. Our data demonstrates the feasibility of outpatient SUD and efficacy of ppx toci in significantly reducing CRS rates, and suggests early de-escalation of dosing maintains durability of response while minimizing toxicity. This real world cohort achieved similar response rates with a frail and older population, and included a large black population compared to the trial."

Clinical • Infectious Disease • Multiple Myeloma • Pneumonia • Respiratory Diseases

Initial Experiences of Outpatient Bispecific Antibody Administration at a Large Academic Center (IMS 2026) - "Four BsAbs (teclistamab, talquetamab, elranatamab, and linvoseltamab) are approved in the United States and in some other countries...At the first sign of CRS or ICANS, pts were instructed to self-administer dexamethasone 12 mg and acetaminophen 650 mg, then contact the provider... This initial single-center experience shows that OP BsAb administration with prophylactic tocilizumab is feasible in selected pts (4/27, 15%) without observed CRS, ICANS, or unplanned hospitalization. These results are consistent with larger studies, indicating that BsAb administration in OP and community settings is feasible when supported by rigorous patient selection and preparedness to manage adverse events. Distances >30 mins from the center represented the primary limitation to OP BsAb and underscores the need to expand community access."

Bispecific • Clinical • Hematological Malignancies • Inflammation • Multiple Myeloma

Updated Safety and Efficacy Results for Linvoseltamab (LINVO) in Patients (Pts) With High-Risk Smoldering Multiple Myeloma (HR-SMM): Phase 2 LINKER-SMM1 Trial (IMS 2026) - P2 | "With additional enrollment and follow-up ( n=36; median 8.6 mos ) in LINKER-SMM1, LINVO monotherapy continued to demonstrate deep and ongoing response s (100% ORR, 97% ≥ VGPR, 69% ≥CR) with a tolerable safety profile , support ing its role as a promising treatment strategy for HR- SMM. Further updated data as of May 2026 will be presented at the meeting. A P hase 3 registrational study is ongoing."

Clinical • P2 data • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Smoldering Multiple Myeloma

Linvoseltamab Shows 100% Response Rate in Smoldering Myeloma, Raising Early-Intervention Question (Pharmacy Times) - "In this update, 32 evaluable patients with HR-SMM who completed at least 1 treatment cycle achieved a 100% investigator-assessed overall response rate per International Myeloma Working Group (IMWG) criteria, with 97% reaching very good partial response (VGPR) or better and 69% reaching complete response (CR). Responses continued to deepen over time, and among MRD-evaluable patients with VGPR or better, 100% reached MRD negativity at the 10⁻⁵ threshold and 10⁻⁶ sensitivity. No patient progressed to active myeloma during the observation period."

P2 data • Multiple Myeloma

Linvoseltamab (LINVO) + carfilzomib (CFZ) in patients (pts) with relapsed/refractory multiple myeloma (RRMM): Initial results from the LINKER-MM2 trial. (ASCO 2025) - P1 | "Dexamethasone premedication was limited to C0–1. LINVO + CFZ induced a high rate of deep and durable responses with a safety profile consistent with the individual drugs, supporting further development. Enrollment at 200 mg LINVO in combination with CFZ is ongoing."

Clinical • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Oncology • Thrombocytopenia

LINVOSELTAMAB + CARFILZOMIB IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA: INITIAL RESULTS FROM THE LINKER-MM2 TRIAL (EHA 2025) - P1 | "Dexamethasone premedication was limited to C0-1. LINVO + CFZ induced a high rate of deep and durable responses with a safety profile consistent with the individual drugs, supporting further development. Enrollment of patients receiving LINVO 200 mg in combination with CFZ is ongoing."

Clinical • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Oncology • Thrombocytopenia

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

Effectiveness of linvoseltamab versus real-world standard-of-care in triple-class-exposed relapsed/refractory multiple myeloma in the United States. (PubMed, Blood Cancer J) - P1/2 | "The most common SOC regimens were combinations of carfilzomib, pomalidomide, and dexamethasone (8.6%) and daratumumab, pomalidomide, and dexamethasone (8.2%). No patients received chimeric antigen receptor T cell therapy or bispecific antibodies. Linvoseltamab had a higher objective response rate than RW SOC (weighted odds ratio 3.8 [95% CI: 2.5-6.6]), and longer median progression-free survival (weighted hazard ratio [wHR] 0.29 [95% CI: 0.23-0.39]), time to next treatment (wHR 0.20 [95% CI: 0.15-0.26]), and overall survival (wHR 0.41 [95% CI: 0.32-0.52]), demonstrating its potential as an effective treatment for 3L+ and TCE/TCR RRMM."

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

Real-World Comparative Survival and Hospitalization Outcomes After CAR-T Relapse in Relapsed/Refractory Multiple Myeloma: Bispecific Antibodies Versus Conventional Chemotherapy (SOHO 2026) - "Adult patients with RRMM who received BCMA-directed CAR-T therapy followed by either BsAbs (teclistamab, elranatamab, linvoseltamab, talquetamab) or cCT (including selinexor-based regimens, alkylators, proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies) were included. In this real-world post–CAR-T RRMM cohort, BsAbs were associated with significantly improved OS compared with cCT, with numerically lower hospitalization rates. These findings support BsAbs as an effective post–CAR-T strategy and warrant prospective validation. GPRC5D: G protein-coupled receptor class C group 5 member D."

Bispecific • CAR T-Cell Therapy • Clinical • Real-world • Real-world evidence • Hematological Malignancies • Multiple Myeloma • Oncology

Linvoseltamab (LINVO) + bortezomib (BTZ) in patients (pts) with relapsed/refractory multiple myeloma (RRMM): First results from the LINKER-MM2 trial. (ASCO 2025) - P1 | "Dexamethasone premedication was limited to C0–1...One DLT occurred at DL2 (Gr 3 CMV colitis on day 48; resolved with tx delay and ganciclovir)... LINVO + BTZ induced high response rates, with encouraging early DOR and PFS, in a population that was mostly PI-refractory. Safety was consistent with the known profile of each drug, and risk of Gr 3–5 infection was similar to LINVO monotherapy. These data will inform LINVO combination strategies for earlier LoT."

Clinical • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Inflammation • Multiple Myeloma • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Thrombocytopenia

Prophylactic Tocilizumab During Bispecific Antibody Step-Up Dosing in Relapsed/Refractory Multiple Myeloma: CRS Mitigation, Low-Dose Strategies, and Outpatient Feasibility (SOHO 2026) - "Any-grade CRS occurred in 10.1%, with drug-specific CRS rates of 13% for talquetamab, 12.5% for elranatamab, 8.9% for teclistamab, and 0% for linvoseltamab. Early single-center data suggest that prophylactic tocilizumab may reduce CRS severity and support outpatient bispecific antibody step-up dosing in carefully selected patients with RRMM. The evidence remains limited by nonrandomized design, institutional selection criteria, variable dosing strategies, and limited prospective data on ICANS, infections, efficacy, and health care utilization. Multicenter prospective studies are needed to define optimal dose, timing, and patient selection."

Bispecific • Clinical • Hematological Malignancies • Multiple Myeloma • Oncology

Safety and Efficacy of Linvoseltamab (LINVO) in Patients (Pts) with High-risk Smoldering Multiple Myeloma (HR-SMM): First Results from the Phase 2 LINKER-SMM1 Trial (IMS 2025) - P2 | "Tocilizumab was used in 2 pts. LINVO in HR-SMM was highly active with 100% ORR, and the safety profile appeared more favorable compared to RRMM. These data support further investigation of LINVO as an early intervention for SMM."

Clinical • P2 data • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Respiratory Diseases • Smoldering Multiple Myeloma

Hematotoxicity and immune deficits with bispecific antibodies: A systematic review and meta-analysis in lymphoma and multiple myeloma (ASH 2025) - "Among NHL cohorts, the BsAb distribution was: 7 glofitamab, 6 mosunetuzumab, 5 epcoritamab, and 4 odronextamab. Among MM cohorts, 6 received teclistamab, 3 talquetamab, 1 teclistamab and talquetamab, 2 elranatamab, 2 linvoseltamab and 1 etentamig (ABBV-383)... Cytopenias affect a substantial proportion of patients treated with BsAbs, particularly in MM and in NHL with combination regimes. These findings support the need for systematic hematologic monitoring, IG surveillance and tailored pre-emptive strategies to mitigate infection risk.This study represents the first and most comprehensive meta-analysis of hematotoxicity and immune deficits with BsAbs, establishing a benchmark across clinical settings."

Retrospective data • Review • Hematological Malignancies • Infectious Disease • Lymphoma • Multiple Myeloma • Neutropenia • Non-Hodgkin’s Lymphoma • Thrombocytopenia

Opportunistic Neurologic Infections With CD3-Engaging Bispecific Antibodies in Hematologic Malignancies: A FAERS Disproportionality Analysis (SOHO 2026) - "Interventions: Included agents were teclistamab, elranatamab, talquetamab, linvoseltamab, blinatumomab, mosunetuzumab, epcoritamab, and glofitamab. In FAERS, CD3-engaging bispecific antibodies showed strong pharmacovigilance signals for opportunistic neurologic infections, predominantly progressive multifocal leukoencephalopathy/JC virus events, with the most consistent signals observed for BCMA-directed agents. FAERS signals do not establish incidence or causality, but surveillance for opportunistic CNS infections should be considered in postmarketing safety frameworks for bispecific antibodies. AIDS: acquired immunodeficiency syndrome, BCMA: B-cell maturation antigen, CAR-T: chimeric antigen receptor T-cell, CD: cluster of differentiation, FDA: US Food and Drug Administration, HIV: human immunodeficiency virus, JC: John Cunningham, MM: multiple myeloma, OR: odds ratio."

Bispecific • Acute Lymphocytic Leukemia • B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • CD20

Cardiovascular Adverse Event Reporting Patterns With BCMA-Directed CAR-T and BCMA/GPRC5D Bispecific Antibodies in Relapsed/Refractory Multiple Myeloma: A FAERS Disproportionality Analysis (SOHO 2026) - "Interventions: Included therapies were idecabtagene vicleucel, ciltacabtagene autoleucel, teclistamab, elranatamab, talquetamab, and linvoseltamab. Cardiovascular AE reporting differed across RRMM immune-effector therapies. Idecabtagene vicleucel showed the strongest product-level signal, while bispecific antibodies demonstrated a modestly higher platform-level reporting burden. These findings are hypothesis generating and do not establish incidence or causality."

Adverse events • Bispecific • CAR T-Cell Therapy • Hematological Malignancies • Multiple Myeloma • Oncology

Incidence of Parkinsonism and Non-ICANS Neurotoxicity With BCMA-Targeting Bispecific Antibodies vs CAR T-Cell Therapy in Multiple Myeloma: A Systematic Review and Meta-Analysis (SOHO 2026) - "BCMA-targeting bispecific antibodies (BsAbs)—teclistamab, elranatamab, linvoseltamab, pavurutamab—also redirect T cells to BCMA, yet the incidence of parkinsonism with these agents has not been systematically characterized...FAERS analysis (2832 events across teclistamab, talquetamab, elranatamab) identified non-ICANS neurotoxicity (41 events) and peripheral neuropathy (46 events) but no parkinsonism signal... Parkinsonism and MNT are established complications of BCMA CAR-T, particularly cilta-cel, likely reflecting sustained T-cell expansion. Parkinsonism has not been identified with BCMA BsAbs in clinical trials or pharmacovigilance data, possibly due to lower magnitude and shorter duration of T-cell activation. However, systematic underreporting and limited follow-up may obscure the true incidence."

Bispecific • CAR T-Cell Therapy • IO biomarker • Retrospective data • Review • Hematological Malignancies • Multiple Myeloma • Oncology

Infectious Morbidity With Bispecific T-Cell Engager Antibody Therapy in Relapsed/Refractory Multiple Myeloma: A Systematic Synthesis Revealing a Preventable Survival Gap (SOHO 2026) - "Interventions evaluated were teclistamab, elranatamab, and linvoseltamab (BCMA-directed BsAbs), and talquetamab (GPRC5D-directed BsAb) as monotherapy. Infectious morbidity is the dominant real-world driver of the BsAb trial-to-practice gap in RRMM. These findings quantify the benefit magnitude of preemptive IgG replacement, consistent with existing NCCN guidance. Future trials should incorporate infectious endpoints and prophylaxis protocols as co-primary objectives."

Bispecific • IO biomarker • Hematological Malignancies • Multiple Myeloma • Oncology

Facial Palsy Reports With BCMA × CD3 and GPRC5D × CD3 Bispecific Antibodies in Relapsed/Refractory Multiple Myeloma: A FAERS Disproportionality Analysis (SOHO 2026) - " FAERS reports from January 1, 2022, through May 13, 2026, were queried for the BCMA × CD3 agents elranatamab, teclistamab, and linvoseltamab and the GPRC5D × CD3 agent talquetamab using nonproprietary and brand-name variants. Facial palsy may represent an underrecognized focal cranial neuropathy associated withRRMM bispecific antibody therapy, beyond the broader ICANS or peripheral neuropathy categories. Because FAERS lacks exposure denominators and causal adjudication, these signal-generating findings warrant validation through prospective studies or registries capturing cranial nerve events. BCMA: B-cell maturation antigen, CD: cluster of differentiation, GPRC5D: G-protein–coupled receptor family C group 5 member D."

Bispecific • Hematological Malignancies • Multiple Myeloma • Oncology

Safety Outcomes Associated With Bispecific Antibody Therapy in Relapsed/Refractory Multiple Myeloma: A Systematic Review and Meta-Analysis (SOHO 2026) - "The primary analysis included six phase 1/2 cohorts (N = 850) from four agents: teclistamab, elranatamab, linvoseltamab, and talquetamab. BsAbs in RRMM are associated with a complex safety profile, characterized by a multidomain toxicity burden extending beyond CRS, with substantial infectious morbidity and under-recognized cardiovascular risk. Pharmacovigilance signals, particularly with teclistamab, suggest that cardiovascular toxicity may be underestimated in clinical trials. These findings support proactive infection prophylaxis, immunoglobulin replacement, and structured cardiovascular monitoring throughout treatment."

Bispecific • Retrospective data • Review • Hematological Malignancies • Multiple Myeloma • Oncology

Secondary Primary Malignancies Associated With BCMA-Directed Bispecific Antibodies in Relapsed/Refractory Multiple Myeloma: A FAERS Pharmacovigilance Analysis (SOHO 2026) - "Background: Four BCMA-directed bispecific antibodies (BsAbs), teclistamab, talquetamab, elranatamab, and linvoseltamab, are FDA-approved for relapsed/refractory multiple myeloma (RRMM) after at least four prior lines of therapy. These findings provide a baseline estimate of SPM burden with BsAbs in RRMM. Teclistamab is associated with a significant SPM signal, mostly skin cancers, while elranatamab and talquetamab show lower signals with mostly hematologic SPMs. This pattern suggests heterogeneity within the class rather than a uniform class-wide risk."

Adverse events • Bispecific • Hematological Malignancies • Multiple Myeloma • Oncology • Skin Cancer • Solid Tumor