Talvey (talquetamab-tgvs) / J&J, Genmab - LARVOL DELTA

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

Feasibility and safety of bispecific antibodies outpatient model in triple-refractory multiple myeloma patients in two Italian centers (ASH 2025) - "All patients underwent premedication with acetaminophen, chlorphenamine and dexamethasone during SUD and first full dose whereas three patients received post-medication with dexamethasone 16 mg the day after SUD1, SUD2 and first full dose...Seven patients were treated with teclistamab and one with talquetamab, approved after teclistamab in Italy...For both these two patients, tocilizumab was administered with rapid resolution of CRS and no need of hospitilization...A solid collaboration with emergency room doctors and nurses, the education of the patient and the outline of a path to rapidly and safely manage complications has been documented to be crucial. These encourage the feasibility of managing BSAbs therapy for MM patients in an outpatient setting in hub centres where multidisciplinary collaboration can be easily achieved."

Clinical • CNS Disorders • Hematological Disorders • Hematological Malignancies • Hypotension • Multiple Myeloma

Cardiovascular adverse events associated with bispecific antibodies in Relapsed/Refractory hematologic malignancies: A comprehensive systematic review and meta-analysis (ASH 2025) - "The study included seven bispecific antibodies (BsAbs) : blinatumomab , mosunetuzumab , elranatamab , epcoritamab , glofitamab , talquetamab , and teclistamab . While bispecific antibodies (BsAbs) show promising results in managing R/R hematologic malignancies, their use can lead to significant cardiac adverse effects, including tachycardia, arrhythmias, and hypotension. To mitigate these risks, a multidisciplinary approach—incorporating vigilant cardiac monitoring, preventive strategies, and prompt intervention—is essential for optimizing patient care and treatment success. Risk of Bias was relatively low."

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

Incidence of second primary malignancies (SPMs) following bispecific antibody (BsAb) therapy for lymphoid malignancies: A descriptive analysis of clinical trials (ASH 2025) - "Included agents were blinatumomab (CD19×CD3), glofitamab, mosunetuzumab, epcoritamab, and odronextamab (all CD20×CD3), as well as elranatamab, teclistamab, and linvoseltamab (BCMA×CD3), and talquetamab (GPRC5DxCD3). Notably, some reported cases may represent disease progression rather than true SPMs. However, limited follow-up duration across trials warrants continued long-term surveillance, particularly as agents move to frontline settings where longer survival may reveal delayed malignancies."

Clinical • Acute Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Hodgkin Lymphoma • Leukemia • Lung Cancer • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • CD20

Comparative analysis of fatal serious adverse events associated with FDA-approved bispecific antibodies in hematologic malignancies (ASH 2025) - " Using the FDA Adverse Events Reporting System (FAERS) public dashboard case-listing feature up to Q2 2025, individual reports listings with death as an outcome were extracted for all FDA-approved BsAbs/BiTEs: blinatumomab, glofitamab, epcoritamab, teclistamab, elranatamab, and talquetamab. The FAERS-based analysis aligns with literature on BsAb/BiTEs toxicities: CRS and infections are consistently reported fatal SAEs, with ICANS more notable in BCMA-targeting agents. Notably, our study also reveals underappreciated signals: cardiovascular fatal events, rare neurological syndromes beyond ICANS, and opportunistic infections—which are not prominently featured in the literature but appear in real-world fatal outcomes. These findings highlight both expected and emerging fatal toxicity patterns across FDA-approved BiTEs/BiAbs."

Adverse events • Serious adverse event • Acute Lymphocytic Leukemia • CNS Disorders • Hematological Malignancies • Hypotension • Infectious Disease • Leukemia • Oncology • Pneumonia • Respiratory Diseases • Septic Shock

Comprehensive cost analysis of 4th line + therapies for relapsed/refractory multiple myeloma in Germany: Drug, co-medication, and office-based treatment perspective (ASH 2025) - "Whilst there is no official myeloma registry in Germany, treatments we considered were reimbursable combination therapies frequently used in the 4 th line treatment of RRMM in Germany in 2023, containing: carfilzomib, daratumumab, elotuzumab, melflufen, selinexor, talquetamab and teclistamab, and newly approved therapeutic options like elranatamab, along with evidence-based recommendations regarding premedication, comedication, and mandatory prophylaxis of treatment-related adverse events, as outlined in the Summary of Product Characteristics (SmPC) and published literature... Costs for myeloma drugs and combinations show a broad variation, from 88.863€ for Elotuzumab/Revlimid/Dexamethasone (ERd), to 178.850€ for talquetamab treatment. The second lowest in terms of annual costs was melflufen with 106.839€, followed by Elotuzumab/Pomalidomide/Dexamethasone (EPd):119.301€, teclistamab: 124.626€, Selinexor/Dexamethasone (Sd): 129.976€, elranatamab: 146.706€ and..."

Cost-analysis • HEOR • Hematological Malignancies • Multiple Myeloma

Use of bispecific antibody talquetamab before leukapheresis may lead to out-of-specification ciltacabtagene autoleucel manufacturing: A university of Arizona experience (ASH 2025) - "One IS patient received prior bendamustine; none in the OOS group did. Exposure to bispecific T-cell engager therapy was significantly more common in the OOS group (4/5 vs. 1/10; p = 0.016), with all OOS exposures involving talquetamab and the IS exposure involving teclistamab... In this single-institution cohort, patients who received OOS cilta-cel products experienced safety and efficacy outcomes comparable to those treated with IS products. These findings support the potential utility of selected OOS CAR T-cell products under appropriate oversight. Exposure to talquetamab prior to leukapheresis was significantly associated with OOS product status."

Hematological Malignancies • Infectious Disease • Influenza • Multiple Myeloma • Respiratory Diseases

The development of FT839: An off-the-shelf CD19xCD38 dual-CAR T cell for the treatment of multiple myeloma (ASH 2025) - "In vitro cytotoxicity assays against MM cell lines RPMI-8226, OPM2, MM1.s and H929 demonstrated durable and potent cell cytotoxicity at low effector:target ratios, as a monotherapy with further deepening of response when combined with mAbs such as daratumumab or sarclisa, or T cell engagers such as teclistamab or talquetamab (exceeding 90% cytotoxicity in each case). Collectively, FT839 is engineered to eliminate cancer cells with broad and heterogenous antigen expression by a unique dual-CAR system and in combination with standard of care therapeutics, including mAbs and TCEs via hnCD16 and CD3-CFR transgenes, to overcome multiple challenges that have limited autologous CAR T-cell therapies in treating MM. Moreover, as an off-the-shelf CAR T-cell therapy, FT839 is intended for broad and on-demand access without the need for complicated and variable manufacturing processes or intense conditioning chemotherapy."

CAR T-Cell Therapy • IO biomarker • Hematological Malignancies • Multiple Myeloma

Efficacy of tocilizumab prophylaxis in preventing cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome: A systematic review and meta-analysis (ASH 2025) - "The Bispecific antibodies used were Teclistamab. Eltranatamab, Talquetamab, and Linvoseltamab... Tocilizumab is a viable option for preventing all grades of CRS and ICANS following CAR-T cell therapy and Bispecific antibodies. Randomized trials with larger patient populations are needed to further demonstrate its efficacy, safety, and the impact on treatment responses."

Cytokine release syndrome • Retrospective data • Review • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Infectious Disease • Inflammation • Leukemia • Lymphoma • Mantle Cell Lymphoma • Multiple Myeloma • Neutropenia • Non-Hodgkin’s Lymphoma • Thrombocytopenia

Real-world outcomes and toxicities of elranatamab (ELRA) in relapsed/refractory multiple myeloma: A retrospective analysis using the trinetx global health research network. (ASH 2025) - "Treatment exposure patterns indicated a heavily pretreated, triple-class refractory population: proteasome inhibitors (bortezomib 61%, carfilzomib 47%), IMiDs (lenalidomide 67%, pomalidomide 69%), and anti-CD38 monoclonal antibodies (daratumumab 67%). Additional therapies included CAR T-cell therapy (8%), autologous stem cell transplant (23%), Belantamab mafodotin (8%), Talquetamab (10%), and Teclistamab (8%)...Tocilizumab was used in 21% of patients... In comparison to the MagnetisMM-3 trial, this real-world analysis confirms the manageable immune toxicity profile of ELRA, with similarly low rates of grade ≥3 CRS and ICANS. However, the higher 6-month mortality (22.6%) observed in this cohort may reflect broader patient inclusion, including those with significant comorbidities and prior BCMA-directed therapies. Hematologic and infectious toxicities were substantial, reinforcing the need for enhanced monitoring and supportive care strategies in routine clinical use."

Real-world • Real-world evidence • Retrospective data • Hematological Disorders • Hematological Malignancies • Infectious Disease • Influenza • Leukemia • Multiple Myeloma • Nephrology • Neutropenia • Plasma Cell Leukemia • Pneumonia • Respiratory Diseases • Septic Shock • Thrombocytopenia

Real-world outcomes and toxicities of talquetamab (Tal) in Relapsed/Refractory multiple myeloma (RRMM): A retrospective analysis using the trinetx global health research network. (ASH 2025) - "Treatment patterns reflected a triple-class refractory population, with high prior exposure to proteasome inhibitors (bortezomib 52%, carfilzomib 48%), IMiDs (lenalidomide 66%, pomalidomide 63%), and anti-CD38 antibodies (daratumumab 51%). Additionally, 35% had received CAR T-cell therapy, 39% underwent ASCT, 24% were treated with Teclistamab, and extramedullary disease and plasma cell leukemia were reported in 11% and 13% of patients, respectively...Grade ≥3 CRS and ICANS occurred in <10 patients each (2.4%), and 24% received tocilizumab for CRS... In this large, real-world cohort, Talquetamab demonstrated favorable short-term survival and a manageable safety profile, consistent with clinical trial data. The higher mortality observed may reflect the heavily pretreated, triple-class refractory population with advanced disease features and comorbidities often seen in real-world settings. Hematologic toxicities remained significant, while lower observed rates of..."

Real-world • Real-world evidence • Retrospective data • Dermatology • Multiple Myeloma • Neutropenia • Plasma Cell Leukemia • Thrombocytopenia

Prophylactic tocilizumab in Relapsed/Refractory multiple myeloma patients treated with bispecific antibodies: A single centre experience (ASH 2025) - "Twelve patients (46%) had received previous anti-BCMA therapy (8 belantamab, 2 both belantamab and teclistamab, 1 teclistamab and 1 idecel). Talquetamab was administered to 16 patients (61%), teclistamab to 8 (30%), elranatamab to 2 (8%)...Premedication for each step up dose included dexamethasone, acetaminophen and diphenhydramine...This data supported, in our center, the use of prophylactic tocilizumab in outpatient setting. Given these results, even if all CRS events were grade 1, remained fully manageable and ICANS were rare, the use of prophylactic tocilizumab could improve treatment safety, inpatient management, and ultimately support feasibility in the outpatient regimen."

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

Dermatologic toxicities associated with talquetamab in patients with Relapsed/Refractory multiple myeloma: A systematic review and meta-analysis (ASH 2025) - "Of these, 3 studies (n=194 patients) utilized combination therapy (talquetamab with daratumumab, teclistamab, or pomalidomide), while 5 studies (n=622 patients) administered talquetamab as a monotherapy. The frequency of skin toxicities did not differ significantly between monotherapy and combination therapies. The limited reporting on the grading of skin toxicities highlights the need for further research to more comprehensively define the spectrum of talquetamab-associated adverse events in a clinical setting."

Retrospective data • Review • Dermatology • Hematological Malignancies • Infectious Disease • Multiple Myeloma

Real‑world matched comparison of talquetamab versus teclistamab in Relapsed/Refractory multiple myeloma (ASH 2025) - "Talquetamab was associated with higher early-onset neutropenia yet showed numerically fewer serious infections, whereas CRS and ICANS remained low-grade for both agents. Bispecific antibody selection decision should weigh in baseline marrow reserve and infection risk until longer follow-up clarifies durability and late-onset toxicities."

Clinical • Real-world • Real-world evidence • Acute Kidney Injury • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Nephrology • Neutropenia • Pneumonia • Renal Disease • Respiratory Diseases • Septic Shock • Thrombocytopenia

First results of aponermin(Apo) improving teclistamab (tec)/talquetamab (tal) in patients (pts) with Relapsed/Refractory multiple myeloma (RRMM) (ASH 2025) - P=N/A | " As of August 3, 2025, 6 pts received Apo+ Tec (including 1pts with Tal causing resistant of BCMA) +Thalidomide. In this first combination study of Apo+BCMA-/GPRC5D-targeted bispecific antibody, at the RP2R has a manageable safety profile consistent with each of the monotherapies. In dose level 2, a 100% ORR was observed in pts with advanced RRMM at the RP2R, and an ORR of 66.7% was achieved in pts with EMD, a high-risk population with unmet need, supporting further evaluation of the combination. Clinical trial information: ChiCTR2500106279."

Clinical • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Nephrology • Neutropenia • Renal Disease • Thrombocytopenia

Oral Care™ kit as a prophylaxis for talquetamab-associated toxicities in patients with Relapsed/Refractory multiple myeloma (ASH 2025) - "Oral toxicities were common in both the kit and non-kit groups, with dysgeusia being the most frequently reported symptom. While the overall profile of oral events differed slightly between groups, no clear pattern of benefit associated with the Oral Care™ Kit was observed. Weight loss after one full treatment cycle appeared greater in the kit group, although the difference did not reach statistical significance."

Clinical • Anorexia • Dental Disorders • Dermatology • Gastrointestinal Disorder • Hematological Malignancies • Multiple Myeloma • Preventive care • Stomatitis • Xerostomia

Comparative disproportionality analysis of cytokine release syndrome associated with FDA-approved bispecific T-cell engagers in relapsed/refractory multiple myeloma (ASH 2025) - " We extracted individual retrospective case safety reports from the FAERS database for three BiTE therapies—teclistamab, talquetamab, and elranatamab—used in individuals with "plasma cell myeloma" as the disease indicator. CRS is a consistent and significant adverse event across all FDA-approved BiTE therapies for RRMM. Among these agents, teclistamab demonstrated the highest disproportionality signal for CRS, whereas elranatamab exhibited the lowest. These differences may reflect variations in cytokine activation profiles or administration protocols and could help guide treatment decisions and CRS mitigation strategies in clinical practice."

Cytokine release syndrome • Hematological Malignancies • Inflammation • Multiple Myeloma

Adverse events in Relapsed/Refractory multiple myeloma (RRMM) patients receiving bi-specific T-cell antibodies (BsAbs): A systematic review and meta-analysis of real-world evidence (ASH 2025) - " On June 1, 2025, we conducted a literature search in PubMed and Embase using controlled vocabularies and keywords related to MM, BsAbs, teclistamab, talquetamab, and elranatamab. In the meta-analysis, about half of RRMM patients using teclistamab can experience CRS, and about three-fourths of talquetamab users can have CRS. ICANS is not frequently observed in teclistamab and talquetamab users. In teclistamab users, prior treatment burden could be positively associated with CRS and hematotoxicity."

Adverse events • HEOR • Real-world • Real-world evidence • Retrospective data • Review • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Leukopenia • Multiple Myeloma • Neutropenia • Thrombocytopenia

Real-world data on anti-BCMA CAR-T in Brazil: A single-center retrospective case series (ASH 2025) - "Background : The treatment landscape for relapsed/refractory Multiple Myeloma (R/R MM) in Brazil is unique, with both BCMA CAR-T (ciltacabtagene autoleucel, cilta-cel) and bispecific antibodies (teclistamab, talquetamab, elranatamab) being available for patients who are triple class exposed, but without the necessity of a specific number of previous lines of therapy (LoTs). Ciltacel is also approved based on lenalidomide refractoriness and previous proteasome inhibitor exposure...Of the other 5 patients, 3 did not fulfill CARTITUDE-1 criteria due to cytopenia (2/3), previous BCMA therapy with teclistamab and belantamab mafodotin (1/3) and non-secretory disease (1/3)...Tocilizumab was commonly used (4/7)... Access to CAR-T therapy for multiple myeloma in Brazil is often marked by extensive delays, resulting in a prolonged and complex treatment journey. Most patients wouldn't have fulfilled inclusion/exclusion criteria for the clinical trials the led to ciltacel..."

Real-world • Real-world evidence • Retrospective data • Hematological Malignancies • Multiple Myeloma

Impact of obesity on CRS and icans in patients with multiple myeloma receiving bispecific antibodies: A real-world analysis (ASH 2025) - "There was no time restriction but only patients aged ≥18 years with a diagnosis of MM and exposure to FDA-approved BsAb therapy (talquetamab and teclistamab) were included . In this real-world cohort, obesity showed modest risk of CRS/ICANS. However, it was not associated with an increased risk of CRS or ICANS in patients treated with bispecific antibodies compared to other BMI cohorts. The results are limited by the inherent heterogeneity of registry data, including variability in data quality, completeness, and coding practices across sites."

Clinical • IO biomarker • Real-world • Real-world evidence • Genetic Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Obesity • Septic Shock • CD8 • IL1B • IL6

Talquetamab induces deep responses in heavily pre-treated patients with systemic light-chain amyloidosis (ASH 2025) - "All were refractory to daratumumab, bortezomib, cyclophosphamide, and pomalidomide; four were refractory to lenalidomide and belantamab mafodotin; one patient with t(11; 14) was refractory to venetoclax. Three relapsed after anti-BCMA academic CAR-T (HBI0101). Additional therapies included ixazomib (2), carfilzomib (1), elotuzumab (1), and melphalan (1)... Talquetamab produced deep and durable hematologic responses in heavily pretreated patients with R/R AL amyloidosis. Assessment of organ response potential was limited by irreversible organ dysfunction at baseline and short follow-up. Treatment was feasible, including in end-stage renal disease, and the safety profile was manageable without unexpected toxicities."

Clinical • Amyloidosis • Cardiovascular • Congestive Heart Failure • Dental Disorders • Heart Failure • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Nephrology • Renal Disease • Septic Shock • Thrombocytopenia • Xerostomia

Ktx-1001, a potent, selective MMSET/NSD2 inhibitor, enhances immunomodulatory and immune-directed therapies in preclinical models of multiple myeloma (ASH 2025) - P1 | " MM cell lines harboring t(4; 14) translocation and resistant to standard therapies were treated with escalating concentrations of KTX-1001 in combination with pomalidomide (POM), mezigdomide (MEZI), anti-CD38 monoclonal antibodies (daratumumab, [DARA], isatuximab, [ISA]), and T-cell engagers (teclistamab (TEC, anti-BCMA) and talquetamab (TALQ, anti-GPRC5D). These preclinicalfindings supportthe therapeutic potential of combining KTX-1001 with immunomodulatory and immune-directed therapies in MM. KTX-1001 demonstrated synergistic reductions in cell viability in IMiD-resistant t(4; 14) cell lines when combined with POM or MEZI. In immune-based co-culture assays, pre-treatment with KTX-1001 enhanced cytotoxicity induced by T-cell engagers, TEC and TALQ in t(4; 14) MM cell lines."

Immunomodulating • IO biomarker • Preclinical • Hematological Malignancies • Multiple Myeloma • CD4 • CD69 • CD8 • NSD2

Single-cell DNA profiling unveils clonal evolution and identifies mechanisms of therapeutic resistance and progression in monoclonal gammopathies (ASH 2025) - "As an example, one patient with biallelic inactivation of GPRC5D in near 90% of the cells prior to TALQUETAMAB treatment, failed to respond, correlating with absent membrane expression of the target...Our data support the clinical relevance of integrating single-cell genomics in the management of plasma cell dyscrasias to tailor therapy and anticipate resistance. Our results suggest that performingsingle-cell genomic and proteomic profiling prior to treatment initiation may improve therapeutic selection and predict response, particularly in the era of targeted immunotherapies."

IO biomarker • Hematological Malignancies • Monoclonal Gammopathy • Multiple Myeloma • Smoldering Multiple Myeloma • GPRC5D • SDC1 • TNFRSF17 • TP53

Evolving real-world uptake and patient characteristics of bispecific antibodies in Relapsed/Refractory multiple myeloma: Insights from a US community oncology network (ASH 2025) - "Background : The treatment landscape for relapsed/refractory multiple myeloma (rrMM) has continued to evolverapidly with the Introduction of T cell directing bispecific antibodies (BsAbs), such as teclistamab-cqyv(approved October 2022), talquetamab-tgvs, and elranatamab-bcmm (both approved August 2023) andlinvoseltamab (approved July 2025). This study demonstrates rapid uptake and steady growth in use of BsAbs in rrMM in a communityoncology setting following regulatory approvals. Patients receiving BsAbs tended to be slightly youngerand with better performance status compared to those receiving other therapies, suggesting patientselection or access disparities. It is encouraging that almost one fifth of patients were receiving BsAbtherapy in the potentially more challenging rural clinic setting."

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

Collaborative outreach and education for management of bi-specific antibody treatment side effects in Relapsed/Refractory multiple myeloma (COMBAT-RRMM) (ASH 2025) - "Three such antibodies, Elranatamab,Teclistamab (targeting BCMA), and Talquetamab (targeting GPRC5D), have received FDA approval inpatients who have received 4 prior lines of therapy due to their impressive response rates andprogression-free survival in clinical trials. Despite about 54 registered attendees for multiple workshops, we only had 22 pre-survey responses and18 post survey responses. Post-intervention, the proportion of participants strongly agreeing with keycompetencies increased substantially: familiarity with BsAbs rose from 14% to 56%, confidence inmanaging side effects from 9% to 61%, understanding of CRS management from 18% to 72%, andcomfort in managing infections from 41% to 56%. All changes were statistically significant (p < 0.05)except for infection management."

Adverse events • Hematological Malignancies • Infectious Disease • Multiple Myeloma