Tecvayli (teclistamab-cqyv) / Genmab, J&J - LARVOL DELTA

From Molecular Precision to Clinical Practice: A Comprehensive Review of Bispecific and Trispecific Antibodies in Hematologic Malignancies. (PubMed, Int J Mol Sci) - "Clinical trials of agents like blinatumomab, glofitamab, mosunetuzumab, and teclistamab have demonstrated deep and durable responses in heavily pretreated populations. Finally, we highlight the transformative role of artificial intelligence (AI) and machine learning (ML) in multispecific antibody development, including antigen discovery, biomarker-driven treatment selection, toxicity prediction, and therapeutic optimization. Together, BsAbs and TsAbs illustrate the convergence of molecular precision, clinical innovation, and AI-driven personalization, establishing a new paradigm for immune-based therapy across hematologic and potentially solid tumor malignancies."

IO biomarker • Journal • Review • Acute Lymphocytic Leukemia • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

…Reimbursement review; Janssen’s Tecvayli fails (Korea Biomedical Review) - "The Health Insurance Review and Assessment Service (HIRA) held its fifth CDRC meeting on Wednesday....Janssen Korea's Tecvayli (teclistamab), a novel bispecific antibody that dual-targets B-cell maturation antigen (BCMA) and the T-cell receptor CD3 in treating relapsed multiple myeloma, failed to set the reimbursement criteria....Tecvalyli won the MFDS approval in July 2023 as a monotherapy for adult patients with relapsed or refractory multiple myeloma who have received three or more prior therapies, including proteasome inhibitors, immunosuppressive agents, and anti-CD38 monoclonal antibodies. The drug has been touted as a treatment that could improve outcomes for multiple myeloma patients with limited treatment options due to multiple relapses, but it failed in the reimbursement challenge."

Reimbursement • Multiple Myeloma

Cost per responder for teclistamab and elranatamab in relapsed or refractory multiple myeloma in the United States. (PubMed, J Med Econ) - P1, P2 | "Because MajesTEC-1 and MagnetisMM-3 are single-arm trials, the MAIC was unanchored and therefore susceptible to confounding from any unadjusted effect modifiers or prognostic variables. Teclistamab was associated with significantly lower treatment costs and numerically lower cost per responder than elranatamab in triple class-exposed RRMM."

Journal • Hematological Malignancies • Multiple Myeloma • Oncology

Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Carfilzomib, Dexamethasone) for Patients With High-risk Multiple Myeloma Refractory or in First Relapse (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: National Cancer Institute (NCI) | Initiation date: Jul 2025 ➔ Oct 2025

Trial initiation date • Hematological Malignancies • Multiple Myeloma • Oncology

One-year remission of therapy-resistant SLE after a single course with the bispecific CD3: BCMA antibody teclistamab, but induction of a non-infectious Crohn's-like inflammatory bowel disease. (PubMed, Ann Rheum Dis) - No abstract available

Journal • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease

B-cell maturation antigen (BCMA) immunohistochemistry (IHC) staining in multiple myeloma (MM) patients with prior use of BCMA-based therapies. (ASCO 2025) - "Among patients with negative BCMA staining, one treated with teclistimab showed no response, while the others were treated with alternative therapies, including talquetamab. BCMA expression can be significantly reduced or absent in MM patients who have received prior BCMA-based therapies, suggesting a mechanism of resistance. Routine BCMA IHC testing maybe needed before initiating additional BCMA-targeted therapies to better guide treatment decisions. Notably, patients without prior BCMA exposure retain BCMA expression, indicating potential benefit from BCMA-targeted therapies in this group."

Clinical • IO biomarker • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Oncology • Plasmacytoma

Infectious complications in relapsed/refractory multiple myeloma patients treated with bispecific antibodies: Meta-analysis. (ASCO 2025) - "Various infection-related adverse events were observed in RRMM patients treated with BsABs. While these therapeutic modalities demonstrate promising efficacy, oncologists, infectious disease physicians, and pharmacists need awareness of potential toxicities to establish strategies for infectious disease prevention and management to provide quality care. Infection related complications of teclistamab, talquetamab, and elranatamab, abridged."

Retrospective data • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Oncology • Pneumonia • Respiratory Diseases

Prophylactic acetaminophen regimen to prevent cytokine release syndrome with teclistamab or talquetamab: A single-center experience. (ASCO 2025) - "Funded by No funding sources reported Background: Teclistamab-cqyv and talquetamab-tgvs are bispecific T-cell engagers approved for relapsed/refractory multiple myeloma (MM) after at least four lines of therapy. Our study suggests that in patients treated with teclistamab for refractory MM, prophylactic scheduled acetaminophen may reduce CRS incidence and severity compared to teclistamab alone. This regimen may provide a cost-effective alternative to tocilizumab with a lower risk of infections. Limitations include small sample size, comparison to historical data, and single-center, retrospective design, which affects generalizability."

Clinical • Cytokine release syndrome • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Oncology

Comparative assessment of colitis-related adverse events in multiple myeloma patients treated with teclistamab, ciltacabtagene, and idecabtagene: Incidence, outcomes, and risk assessment. (ASCO 2025) - "This analysis reveals notable differences in colitis-related AEs among patients treated with teclistamab, ciltacabtagene, and idecabtagene. Teclistamab showed the highest rates of severe colitis, including immune-mediated enterocolitis and Clostridium difficile infections. Ciltacabtagene had a broader spectrum of GI-related AEs and higher mortality rates, requiring careful monitoring."

Adverse events • Clinical • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Immunology • Infectious Disease • Inflammatory Bowel Disease • Multiple Myeloma • Oncology • Ulcerative Colitis

Real-world outcomes of patients with multiple myeloma treated with T-cell engagers compared to those treated on clinical trials. (ASCO 2025) - "Median progression free survival (PFS) among the BCMA x CD3 TCEs teclistamab (Tec) and elranatamab (Elran) and the GPRC5D x CD3 TCE talquetamab (Talq) ranges between 10 to 22 months. Our analysis of RW data in RRMM reveals similar safety data but inferior outcomes compared to those treated with TCEs on clinical trials. Factors such as prior BCMA exposure, EMD, an aggressive disease biology wherein patients are unable to enroll on clinical trials due to delays associated with screening and slot allocation may potentially explain the discrepant inferior outcomes in our study. Patients who started therapy following a ≥PR from last line of therapy had improved ORR, implying that TCE benefit may be greater with low burden disease."

Clinical • Real-world • Real-world evidence • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Nephrology • Oncology • Renal Disease

Impact of racial disparities on efficacy and safety outcomes for patients with RRMM receiving T-cell engagers. (ASCO 2025) - " A single center retrospective chart review of consecutive patients with RRMM treated with commercial teclistamab (Tec), talquetamab (Talq), or elranatamab (Elran) between 1/1/23-10/31/24 was performed. Prior data suggested that MM patients with lower incomes, non-white race, and non-English primary languages experience inferior OS. Yet, our findings demonstrated that in a heavily pretreated cohort, differences in race, income, or insurance did not impact ORR, PFS or OS to TCEs. All patients had access to a subspecialty myeloma center."

Clinical • Multiple Myeloma

Tocilizumab prophylaxis for outpatient administration of teclistamab in relapsed/refractory multiple myeloma. (ASCO 2025) - "Other premedications consisted of dexamethasone (16 mg), acetaminophen (975 mg) and cetirizine (10 mg) for the SUD and first full dose. Healthcare resource utilization is a major challenge in the evolving field of cellular immunotherapy. Prophylactic use of tocilizumab reduces both CRS incidence and severity with a very low rate of admission. Our results support that outpatient administration with tocilizumab prophylaxis is a safe and feasible option for teclistamab SUD."

Clinical • Hematological Disorders • Hematological Malignancies • Inflammation • Multiple Myeloma • Neutropenia • Oncology

Neurologic adverse effects associated with the use of T-cell engager therapy in multiple myeloma: Insights from FAERS database. (ASCO 2025) - "T-cell engager (TCE) therapies, including teclistamab, talquetamab, and elranatamab, have emerged as promising options for heavily pre-treated RRMM. Neurological AEs represent a significant component of the toxicity profile of TCEs in MM, particularly with teclistamab, underscoring the need for vigilant monitoring and early management of complications. Future research should focus on identifying predictive biomarkers and optimizing management strategies to enhance patient outcomes in TCE therapy for RRMM."

Adverse events • CNS Disorders • Hematological Malignancies • Multiple Myeloma • Oncology • Pain

Prophylactic dexamethasone (dex) with outpatient step-up dosing (SUD) of bispecific antibodies (BsAb) in multiple myeloma (MM) vs standard of care (SOC) inpatient observation. (ASCO 2025) - "Funded by No funding sources reported Background: Teclistamab (tec) and talquetamab (tal) are BsAb therapies approved for MM. BsAb SUDs for MM can be given outpt safely and resulted in a reduction of 6.4 hospital days per patient. While prophylactic dex did not reduce CRS incidence, all CRS was of grade 1/2, significantly less tocilizumab was used, and ICANS incidence was numerically lower compared to the SOC group."

Clinical • Hematological Malignancies • Multiple Myeloma • Oncology

Bispecific antibody therapy in central nervous system (CNS) multiple myeloma (MM): Multicenter retrospective study. (ASCO 2025) - " Of the 8 patients, 7 received talquetamab and 1 received teclistamab. BsAbs show promise as a feasible and effective treatment for CNS-MM patients, offering good CNS disease control without an increased risk of CRS or ICANS. These findings underscore the potential of BsAbs in managing this high-risk population and support the need for further investigation."

Retrospective data • CNS Disorders • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology • Plasma Cell Leukemia • Plasmacytoma

Meta-analysis of the cardiovascular adverse effects of bispecific antibodies in malignant hematology therapies. (ASCO 2025) - "The BsAbs in this analysis were blinatumomab, elranatamab, epcoritamab, glofitamab, mosunetuzumab, talquetamab, and teclistamab and only monotherapy regimens were included. As BsAbs have demonstrated promising efficacy and increased use in the treatment of R/R hematologic malignancies, a wide variety of cardiac toxicities have been observed in these patients and more data on these toxicities are documented. This meta-analysis has identified tachycardia, cardiac arrhythmias, and hypotension as the most significant cardiac adverse events in a pooled analysis of multiple BsAbs. Practicing oncologists, cardiologists, and pharmacists need not only to be aware of these potential toxicities, but also to establish strategies for cardiac monitoring, prevention and management in order to provide quality care to cancer patients."

Adverse events • Retrospective data • Acute Lymphocytic Leukemia • Atrial Fibrillation • B Cell Lymphoma • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Malignancies • Hypertension • Hypotension • Leukemia • Lymphoma • Multiple Myeloma • Myocardial Infarction • Non-Hodgkin’s Lymphoma • Oncology

Real-world data on bispecific antibodies (BsAbs) administration in community oncology settings. (ASCO 2025) - "Only 1 patient required tocilizumab. For teclistimab, median PFS has not been reached at 300 days... This study highlights the feasibility of administering BsAbs in appropriately resourced community oncology settings. AON's comprehensive approach to protocol development, staff training, and clinical oversight across the inpatient and outpatient spectrum has facilitated the safe and effective use of BsAbs at a scale previously limited to academic centers. These data underscore the potential for broader adoption of BsAbs in community practices and support the need for further real-world evidence to optimize their integration into routine oncology care."

Clinical • Real-world • Real-world evidence • B Cell Lymphoma • Hematological Malignancies • Infectious Disease • Lung Cancer • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Impact of venous thromboembolism on survival in multiple myeloma patients receiving bispecific antibody therapy: Insights from real-world data. (ASCO 2025) - "However, there is limited information regarding the rates of VTE and survival outcomes with FDA-approved bispecific antibodies (BsAbs) such as teclistamab, elranatamab, and talquetamab...After propensity score matching for covariates [accounting for age, sex, ECOG, BMI, COVID-19, pneumonia types, certain infectious diseases, hypertensive diseases, surgery, and medications (dexamethasone, epoetin alfa, darbepoetin alfa)] although RR lost statistical significance (RR 1.333, 95% CI 0.888-2.001), the MM patients with VTE still had statistically significantly shorter overall survival and higher risk of death (50.07% vs. 72.27% survival probability at 18 months, log-rank test p=0.007; HR 1.989, 95% CI 1.190-3.325). RWD demonstrated that MM patients treated with BsAbs who developed VTE had a higher risk of death and shorter overall survival. Further analysis, possibly evaluating patient-level data on a larger cohort of patients with more sophisticated confounding controls, is..."

Clinical • Real-world • Real-world evidence • Cardiovascular • Hematological Disorders • Hematological Malignancies • Hypertension • Infectious Disease • Multiple Myeloma • Oncology • Pneumonia • Respiratory Diseases • Venous Thromboembolism

Teclistamab in relapsed/refractory systemic AL amyloidosis. (ASCO 2025) - "All were previously treated with Daratumumab and 5/8 had previously undergone autologous stem cell transplant. In patients with relapsed refractory AL Teclistamab showed impressive hematologic activity and manageable side effects. A strong case exists for investigating Teclistamab prospectively in this population. Baseline characteristics and response."

Amyloidosis • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology • Thrombocytopenia • SDC1

Real-world comparison of anti-BCMA vs anti-GPRC5D BiTE therapy in relapsed/refractory multiple myeloma without prior CAR-T cell exposure. (ASCO 2025) - " We performed a multicenter, retrospective, propensity score matched (PSM), safety and efficacy comparison between anti-BCMA (Cohort 1: Teclistamab and Elranatamab) and anti-GPRC5D (Cohort 2: Talquetamab) therapy in rrMM, using TriNetX database. Our analysis of real-world patients with relapsed/refractory multiple myeloma (rrMM) showed similar efficacy and tolerability between anti-BCMA and GPRC5D BiTE therapies. However, the Talquetamab group had a higher rate of CRS, consistent with the high incidence observed in the phase 2 MonumenTAL-1 trial. The extent of comorbidities, safety profile of individual agents and plan for subsequent CAR-T cell therapy can guide the choice between available BiTE therapies."

CAR T-Cell Therapy • Clinical • Real-world • Real-world evidence • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Oncology

KT501, A CD19, BCMA-DIRECTED T-CELL ENGAGER (TCE), LEADS TO DEEP B-CELL DEPLETION AND MINIMAL CYTOKINE RELEASE IN VIVO (EULAR 2025) - "Background: B cell depletion therapies targeting CD19 or BCMA, including Chimeric antigen receptor T-cell (CAR-T) therapies and Bispecific antibody such as blinatumomab and Teclistamab, had shown impressive efficacy in treating B cell malignancy. Those preclinical data strongly support clinical development of KT501 in autoimmune disease treatment, which is expected to move into Phase I trial in Q4, 2025."

Preclinical • Immunology • Inflammatory Arthritis • Oncology • Rheumatoid Arthritis • Rheumatology

SAFETY AND EFFICACY OF T CELL ENGAGER THERAPY IN PATIENTS WITH REFRACTORY AUTOIMMUNE DISEASE (EULAR 2025) - "14 patients with rheumatoid arthritis (RA) were treated with the CD19xCD3 TCE blinatumomab, while 10 patients (systemic sclerosis (SSc), N=3, idiopathic inflammatory myositis (IIM) N=2, IgG4-related disease (IgG4-RD) N=2, primary Sjoegren’s-Syndrome (SjS) N=1, Graves disease (GD) N=1,) and RA N=1) were treated with the plasma cells targeting BCMAxCD3 TCE teclistamab. Together, these results substantiate the feasibility of TCE treatment of to autoimmune disease. Most notable adverse events are low grade cytokine release syndrome and infections. Short term efficacy is high even in a refractory patient population, however relapses occur."

Clinical • Endocrine Disorders • Gastroenterology • Gastrointestinal Disorder • Grave’s Disease • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Myositis • Nephrology • Rheumatoid Arthritis • Rheumatology • Scleroderma • Sjogren's Syndrome • Systemic Sclerosis • IFIH1

Effects of T cell engagers treatment on B and T cells in autoimmune disease (EULAR 2025) - " 14 patients with RA were treated in our department with the TCE CD19xCD3 Blinatumomab, 10 patients with various autoimmune diseases including SSc, IIM, IgG4-RD and GD were treated with the plasma cell-targeting TCE BCMAxCD3 teclistamab...In three patients, B cells were already peripherally depleted because of previous rituximab therapy (mean 3.3 months before blinatumomab [range: 3–4])... Together, these data demonstrate the impact of TCEs on B cell depletion and reconstitution kinetics in AIDs. Furthermore, strong effects on the T cell compartment are observed, raising the intriguing possibility that their mechanism of action is not limited to the B cell depletion alone."

Grave’s Disease • Immunology • Infectious Disease • Inflammation • Inflammatory Arthritis • Myositis • Rheumatoid Arthritis • Rheumatology • Scleroderma • Systemic Sclerosis • CD20 • CD27 • CD8 • PD-1

PHASE 2 STUDY OF TALQUETAMAB + TECLISTAMAB IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA AND EXTRAMEDULLARY DISEASE: REDIRECTT-1 (EHA 2025) - P1/2 | "With 90 pts with confirmed EMD, the phase 2 cohort of RedirecTT-1 is the largest dedicated EMD study to date. Tal + Tec led to a high ORR and deep, durable responses; efficacy exceeded standard therapies, including BsAb monotherapies, and was comparable to CAR-T therapies in pts with RRMM with EMD. No new safety signals were identified, including no exacerbated Tal or Tec AEs."

Clinical • Late-breaking abstract • P2 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Oncology • Plasmacytoma • Pneumonia • Respiratory Diseases • Septic Shock

Teclistamab-Lenalidomide and Teclistamab alone vs Lenalidomide alone in newly diagnosed multiple myeloma as maintenance therapy following autologous stem cell transplantation: Phase 3 MajesTEC-4/EMN30 safety run-in (OeGHO-AHOP 2025) - "Tec-Len and Tec can be safely administered as maintenance therapy following ASCT in NDMM, with a trend for improved early safety outcomes with less frequent Tec dosing. Tec-Len demonstrated deepening responses. The randomized part of MajesTEC-4/EMN30 is actively enrolling."

Clinical • P3 data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Neutropenia • Oncology • Transplantation