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

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)

New P2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Enhancing Health Technology Assessment With Data Transportability Analyses: Addressing Bias and Generalizability Challenges In Non-Local Real-World Evidence (ISPOR 2025) - "For example, external control arm data for teclistamab and elranatamab for the treatment of relapsed/refractory multiple myeloma faced criticism from HTA agencies due to differences in treatment regimens and unmeasured prognostic variables relative to the local HTA jurisdiction. Transportability analyses may be an underused tool offering a rigorous framework for addressing key challenges in adapting non-local RWE to local HTA decision-making. Implementing these methodologies could improve the acceptance of non-local evidence, accelerate patient access to therapies, and support globally harmonized evidence generation and interpretation strategies. Further development of practical guidelines and case studies are essential to standardize these methods and ensure broader adoption in HTA practice."

Clinical • HEOR • Real-world • Real-world evidence • Hematological Malignancies • Multiple Myeloma • Oncology • Rare Diseases

Use of Novel Therapies for Multiple Myeloma in the United States: Important Differences in Patient Characteristics, Access to Care, and Real-World Treatment Challenges (ISPOR 2025) - "All pts had ≥1 claim for a CAR-T/BsAb tx including idecabtagene vicleucel, ciltacabtagene autoleucel, teclistamab, talquetamab, or elranatamab, and continuous enrollment ≥90 days before and after index date. Of the 2,442 pts included, 61% received BsAbs and 39% received CAR-Ts. Descriptively, these results suggest important differences in sociodemographic and clinical characteristics among pts who received novel tx for MM. Uptake of BsAbs was higher compared to CAR-Ts, indicating greater tx accessibility for BsAbs. This warrants further investigation into barriers to access and strategies to potentially ameliorate existing health disparities in U.S. MM pts."

Clinical • HEOR • Real-world • Real-world evidence • Hematological Malignancies • Multiple Myeloma • Oncology

Prolonged COVID-19 Pneumonia in Patients with Hematologic Malignancies: Clinical Significance and Serial CT Findings. (PubMed, J Clin Med) - "A total of 56.4% had received B-cell-directed therapies, such as rituximab or teclistamab, within one year of COVID-19 diagnosis. Median CT severity scores during <30 days, 30-59 days, 60-89 days, and ≥90 days from initial diagnosis were 2.0, 2.0, 2.0, and 1.0, respectively. (4) Patients with hematologic malignancies may experience prolonged COVID-19 pneumonia, which is associated with the use of B-cell-directed antibody-based drugs and can result in longer hospital stays and delays in treatments for underlying malignancy."

Journal • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Novel Coronavirus Disease • Oncology • Pneumonia • Respiratory Diseases

Effect of Intravenous Immunoglobulin (IVIG) Supplementation on infection-free survival in recipients of BCMA-directed bispecific antibody therapy for multiple myeloma. (PubMed, Blood Cancer J) - "This is a retrospective study of patients treated with either standard of care teclistamab or BCMA-directed investigational bsAb between Nov 2017 and Dec 2023...On multivariate analysis, primary IVIG prophylaxis was independently associated with improved OS (HR = 0.37; p = 0.021), while the presence of extra-medullary (HR = 2.71; p = <0.001) and high-risk disease (HR = 1.88; p = 0.031) conferred poor outcomes. In recipients of BCMA-directed bsAb, IVIG supplementation was associated with an improved clinical outcome, including favorable IFS and OS."

Clinical • Journal • Retrospective data • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Oncology

MajesTEC-1: Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=302 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Jun 2026 ➔ May 2027

IO biomarker • Trial completion date • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology

Enhanced potency of BCMA/CD19 dual-targeting allogeneic CAR-T cells for relapsed/ refractory multiple myeloma with 4-1BB/TACI intracellular domains (AACR 2025) - P1 | "Furthermore, anti-CD19 CAR-T cells given after high-dose melphalan and stem cell transplantation have shown to improve patient survival and can eliminate MM progenitor cells that are resistant to BCMA-directed CAR-T cells.P-BCMACD19-ALLO1 is a fully allogeneic CAR-T therapy designed to target BCMA and CD19...TSCM -rich CAR-Ts, including our BCMA-targeting allogeneic P-BCMA-ALLO1 CAR-T for RRMM (NCT04960579), have shown favorable efficacy and safety in the clinic.To develop P-BCMACD19-ALLO1, we constructed the BCMA CAR using two fully human, single-domain, heavy-chain variable domains (VHs) that independently bind BCMA and are joined together by a G4S linker in tandem. The tandem anti-BCMA VHs binds to all clinical escape mutants, including teclistamab-resistant R27P mutation...P-BCMACD19-ALLO1 also demonstrates potent, in vitro killing of tumor cells expressing R27P, P33Del, P33S and S30Del escape mutants. Lastly, P-BCMACD19-ALLO1 effectively eliminates primary bone..."

CAR T-Cell Therapy • IO biomarker • Hematological Malignancies • Multiple Myeloma • Oncology • B2M • CD81 • DHFR • TNFA

Clinical validation of a quantitative systems pharmacology (QSP) model of ISB 2001 used for deriving first in human (FIH) dose and efficient phase 1 dose escalation design in relapsed refractory multiple myeloma (RRMM) patients (AACR 2025) - P1 | "This QSP model was benchmarked with teclistamab's clinical data to derive the minimal pharmacologically active dose (MPAD) of ISB 2001[1]. Despite the absence of monkey PK and toxicology data, this QSP-guided approach successfully predicted an optimal FIH dose, clinical PK, safety, and efficacy, while minimizing patient exposure to non-therapeutic doses. With this method, TCEs can be optimized solely for activity against human tumors without requiring cross-reactivity to animal species. Overall, the QSP based FIH calculation approach offers an effective pathway for designing phase 1 studies for future TCEs."

Clinical • IO biomarker • P1 data • Hematological Malignancies • Multiple Myeloma • Oncology

Role of cytokine-induced cell death on efficacy of teclistamab-mediated T cell killing of multiple myeloma cells (AACR 2025) - "In summary, were able to show an in vitro model of differential MM cell response to Teclistamab mediated T cell killing, and that this difference in response was predicated on the MM cells' baseline sensitivity to cytokine mediated cell death via TNF and IFNγ. Thus, further dissecting mechanisms underlying resistance or sensitivity of MM cells to cytokine induced death could suggest therapeutic targets with the potential to enhance the efficacy of anti-MM T cell immunotherapies."

Clinical • Hematological Malignancies • Multiple Myeloma • Oncology • IFNG • TNFA

VTS105: A novel and potent BCMA/GPRC5D/CD3 trispecific T cell engager (TCE) for the treatment of hematologic malignancies and autoimmune diseases (AACR 2025) - "Recently approved T cell engagers targeting BCMA (e.g., Teclistamab) and GPRC5D (e.g., Talquetamab) have demonstrated clinical responses; however, high relapse rates persist due to suboptimal complete response (CR) rates and minimal residual disease (MRD)...VTS105 exhibits potent human PBMC-mediated tumor cell killing across various heterogeneous MM cell lines, outperforming competitors such as JNJ-79635322, IBI3003, and SCR-8572...Evaluations in this indication are currently underway. Currently VTS105 is advancing into CMC and toxicology studies, with an Investigational New Drug (IND) filing planned for the second half of 2026."

IO biomarker • Late-breaking abstract • Trispecific • Hematological Malignancies • Multiple Myeloma • Oncology • GPRC5D

Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis (clinicaltrials.gov) - P=N/A | N=20 | Recruiting | Sponsor: Peking University People's Hospital | Initiation date: Dec 2024 ➔ Mar 2025

Trial initiation date • Amyloidosis

Prophylactic acetaminophen regimen to prevent cytokine release syndrome with teclistamab or talquetamab: A single-center experience. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Cytokine release syndrome • Inflammation

Comparative assessment of colitis-related adverse events in multiple myeloma patients treated with teclistamab, ciltacabtagene, and idecabtagene: Incidence, outcomes, and risk assessment. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Adverse events • Clinical • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Immunology • Multiple Myeloma • Oncology

Tocilizumab prophylaxis for outpatient administration of teclistamab in relapsed/refractory multiple myeloma. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • Hematological Malignancies • Multiple Myeloma • Oncology

Teclistamab in relapsed/refractory systemic AL amyloidosis. (ASCO 2025) - "The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Amyloidosis

Teclistamab in Previously Treated AL Amyloidosis (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital

New P2 trial • Amyloidosis

The first case of Teclistamab interference with serum electrophoresis and immunofixation. (PubMed, Clin Chem Lab Med) - No abstract available

Journal • Hematological Malignancies • Multiple Myeloma • Oncology

Outpatient Management of Bispecific Related Toxicities: An Observational Study of Safety Outcomes and Resource Utilization. (PubMed, JCO Oncol Pract) - "An outpatient-based practice for BsAb administration demonstrated safety and cost savings. The description of our practice and results of this study provide valuable insights into the safety, feasibility, and resource stewardship of outpatient management of BsAbs. Future research should attempt to predict and stratify CRS risk to deliver a tailored supportive strategy and continued increase of outpatient management."

HEOR • Journal • Observational data • Hematological Malignancies • Inflammation • Multiple Myeloma • Oncology

Real-World Evidence Evaluating Teclistamab in Patients with Relapsed/Refractory Multiple Myeloma: A Systematic Literature Review. (PubMed, Cancers (Basel)) - "Tocilizumab use for CRS management was reported in 14 studies, with two indicating CRS rates of 13% and 26% when used prophylactically. Survival and infection outcomes showed wide variability due to short follow-up in most studies. Overall, early RW effectiveness and safety outcomes of TEC were comparable to findings from MajesTEC-1."

HEOR • Journal • Real-world evidence • Review • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Oncology

Economic Impact of Elranatamab for Treatment of Patients with Relapsed or Refractory Multiple Myeloma. (PubMed, Clinicoecon Outcomes Res) - "Total cost of care per month of median PFS over one year was $19,642 with elranatamab, talquetamab ($33,391), teclistamab ($37,791), selinexor plus dexamethasone ($48,784), physician's choice of treatment ($65,886), idecabtagene vicleucel ($78,361), and ciltacabtagene autoleucel ($17,640). Elranatamab for RRMM is projected to result in a minimal to small budget impact over 3 years and good economic value with lower cost of care per month of PFS compared with other available RRMM treatments except for ciltacabtagene autoleucel."

HEOR • Journal • Hematological Malignancies • Multiple Myeloma • Oncology

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) and the NCCN Drugs & Biologics Compendium (NCCN Compendium) for Multiple Myeloma, Version 2.2025. (NCCN)

NCCN guideline • Multiple Myeloma

Teclistamab versus B-cell maturation antigen-targeting chimeric antigen receptor T-cell therapy in multiple myeloma: a comparative effectiveness analysis. (PubMed, Haematologica) - "Not available."

HEOR • Journal • Hematological Malignancies • Multiple Myeloma • Oncology

ResisTec: Analysis of the Resistance and Sensitivity Mechanisms to Teclistamab by Focusing on Single Immune Cell Examination (clinicaltrials.gov) - P=N/A | N=100 | Recruiting | Sponsor: University Hospital, Toulouse | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

Real-world treatment patterns for teclistamab and talquetamab in multiple myeloma (MM): experience from 609 patients. (PubMed, Blood Cancer J) - No abstract available

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

Teclistamab for Patients with Heavily Pretreated Relapsed/Refractory Multiple Myeloma and Renal Impairment. (PubMed, Blood Adv) - "No differences in overall survival or non-relapse mortality were noted. Our findings suggest that treatment with teclistamab is feasible in patients with RI including those on dialysis, with a similar safety and efficacy profile to patients without RI."

Journal • Hematological Disorders • Hematological Malignancies • Inflammation • Multiple Myeloma • Oncology • Renal Disease • Thrombocytopenia