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

Evaluating inobrodib (CCS1477) in combination with teclistamab or elranatamab in patients with Relapsed/Refractory multiple myeloma; Specific cohorts within a Phase I/IIa study evaluating inobrodib in patients with advanced hematological malignancies (ASH 2025) - P1/2 | "This Phase I/II study (Study CCS1477-02) of Ino with pomalidomide and dexamethasone (InoPd) showed high response rates (75% ORR) with a manageable safety profile in heavily pre-treated relapsed/refractory multiple myeloma (RRMM), all of which were refractory to their last line of therapy. Serial blood and bone marrow samples are being collected for exploratory biomarker analysis to understand mechanisms of response to treatment or disease progression. These cohorts will be opened in approximately 8 sites in the UK and US."

Clinical • Combination therapy • IO biomarker • Metastases • P1/2 data • Hematological Malignancies • Multiple Myeloma • Myelodysplastic Syndrome • Oncology • IRF4

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

Plasma cell leukemia: A single institution review of cases (ASH 2025) - "For salvage therapies, 4 patients received DCEP, 2 received PACE-based regimens, 1 patient achieved remission while on teclistamab, one had delayed ASCT (with third line therapy), and one received CAR-T therapy...There was no statistically significant difference in PFS1 (p = 0.86) or OS (p = 0.57) between patients who received conventional chemotherapy and those treated with a daratumumab-based quadruplet induction regimen. Of note, the majority of patients that received these quadruplet regimens did not receive lenalidomide or carfilzomib for induction of PCL. Although the results of this retrospective study showed that there was no significant difference in PFS1 and OS based on induction regimens, some patients received suboptimal regimens due to various constraints including prior treatment regimens, comorbidities, socioeconomic factors, and variabilities in access to care. Despite therapeutic advances in MM, PFS and OS in patients with both pPCL and sPCL remains..."

Clinical • Review • Endocrine Disorders • Hematological Disorders • Hematological Malignancies • Leukemia • Metabolic Disorders • Multiple Myeloma • Nephrology • Plasma Cell Leukemia • Renal Disease • RB1

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

Evaluation of payment reimbursement models for teclistamab administration and monitoring in the community hospital setting (ASH 2025) - "Five doses of tocilizumab were given in model 1 and 0 doses were given in model 2 (p=0.26). Eight doses of supplemental dexamethasone were given in model 1 and 7 doses were given in model 2 (p=0.88)...Conclusion Outpatient model 1 had significantly higher payment reimbursement and net profit margins compared to inpatient model 2. Our study showed that site of care is an important consideration with BsAbs to optimize revenue and minimize costs, in addition to enhancing access among community-based practices."

Clinical • Reimbursement • US reimbursement • Hematological Malignancies • Multiple Myeloma

Inpatient vs outpatient treatment management with teclistamab in relapsed and refractory multiple myeloma: A cost and healthcare resource utilization analysis (ASH 2025) - "Like in the inpatient setting, patients developing CRS in the outpatient setting would be treated with 8mg/kg tocilizumab, steroids, or supportive care. While teclistamab SUD is currently predominantly administered in the inpatient setting in the Netherlands, there is consensus among clinical experts strongly indicating that teclistamab SUD can be administered feasibly, safely and conveniently in the outpatient setting. In addition, it leads to more efficient healthcare resource use and cost savings. While there is heterogeneity in prophylactic medication used to mitigate CRS, potential costs associated with this are largely offset by the hospitalisation costs and potential re-admission costs saved."

Clinical • HEOR • Hematological Malignancies • Multiple Myeloma

Administration- and adverse event-related costs among patients with multiple myeloma treated with B-cell maturation antigen (BCMA)-targeted agents (ASH 2025) - " A 3-year BIM was developed to evaluate administration and AE-related costs for patients with RRMM and ≥1 prior line of therapy who had received belamaf plus bortezomib and dexamethasone (BVd), belamaf plus pomalidomide and dexamethasone (BPd), cilta-cel, ide-cel, or teclistamab. BVd/BPd had substantially lower administration and AE-related costs vs CAR-T and bispecific therapies, which have high costs mostly due to hospitalizations, premedication, and CRS rates."

Adverse events • Clinical • Hematological Malignancies • Multiple Myeloma • Neutropenia • Thrombocytopenia

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

A novel and highly effective truncated BCMA safety switch for adoptive cell therapy (ASH 2025) - "We selected BCMA as a safety switch as i) it is not naturally expressed on immune cells commonly used for adoptive cell therapies including T cells, NK cell, NKT cells, gd T cells, and macrophages, ii) its expression is restricted to plasma cells and a small subset of B cells amongst normal human tissues, and iii) highly effective BCMA-targeting bispecific T-cell engagers, such as teclistamab, elranatamab, and linvoseltamab are readily available in the clinic and used for the treatment of multiple myeloma...To assess the efficacy of the safety switch, CD19 CAR T cells co-expressing either ctBCMA or GPI-BCMA were transduced with GFP and cocultured with a B-cell lymphoma cell line at an effector to target ratio of 1:1 in the absence or presence of teclistamab, elranatamab or belantamab mafodotin or their respective isotype antibody controls...Conclusion In conclusion, our results indicate that either ctBCMA or GPI-BCMA may serve as a novel and highly effective safety..."

Clinical • IO biomarker • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • CD52 • CD55 • GPI • PD-L1

Real-world outcomes of teclistamab in triple-exposed relapsed/refractory multiple myeloma: Brazilian single-center experience (ASH 2025) - "Cytokine release syndrome (CRS) occurred in 62% (39% grade 2–4; 23% grade 3–4), with 93% receiving tocilizumab. We included 19 patients with a median follow-up of 16 months. The mean age was 70.4 years (SD=11.7) and 43% had high-risk cytogenetics (62% Double/Triple-hit) by mSMART criteria. The median number of prior therapy lines was 4 (47% had 2–3 lines; 32%, 4–5; 21%, ≥6)."

Clinical • Real-world • Real-world evidence • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Immunology • Multiple Myeloma • Rare Diseases

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 treatment landscape after anti-BCMA CAR T-cell therapy in relapsed/refractory multiple myeloma: An international Study (ASH 2025) - "Novel BCMA-targeted therapies, such as CAR T-cells (cilta-cel from 2nd line, ide-cel from 3rd line) and bispecific T-cell engagers (e.g., teclistamab, elranatamab from 4th line), have become new standards of care...Abbreviations: K=carfilzomib; E=elotuzumab; Pom=pomalidomide; d=dexamethasone; Isa=isatuximab; F=panobinostat; R=lenalidomide; Tec=teclistamab; X=selinexor; Elra=elranatamab; Belamaf=belantamab mafodotin; Ixa=ixazomib... This real-world study of 100 MM patients relapsing after anti-BCMA CAR T-cell treatment shows that 91% were in their 4th or 5th line of therapy. A large majority were triple-class exposed, and 52% were lenalidomide-refractory. In the absence of a clear standard of care, common treatments were identified: elotuzumab- and isatuximab-based regimens in the 3rd line; teclistamab and elotuzumab-based options in the 4th line; and teclistamab, elranatamab, and belantamab mafodotin in the 5th line."

CAR T-Cell Therapy • Clinical • HEOR • Real-world • Real-world evidence • Cardiovascular • Diabetes • Dyslipidemia • Hematological Malignancies • Hypertension • Metabolic Disorders • Multiple Myeloma • Renal Disease

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 of teclistamab for multiple myeloma in Canada: Multi-institutional report from the Canadian myeloma research group (CMRG) database (ASH 2025) - "In this real-world study, Canadian myeloma pts had similar outcomes to those in the MajesTEC-1 trial. In particular, pts achieving a deep response (at least VGPR) had very favorable PFS and OS at one year, compared to historical outcomes from the LocoMMotion, Mammoth, and CMRG real-world studies. . Given the short follow-up in the current study, efficacy data will be updated at the meeting."

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

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

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