Elrexfio (elranatamab-bcmm) / Pfizer - LARVOL DELTA

A Study to Learn About the Effects of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: C4 Therapeutics, Inc.

New P1 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Trial in progress: A phase 1b/2a study to evaluate mezigdomide in combination with elranatamab in patients with relapsed/refractory multiple myeloma (ASH 2025) - P1/2 | "Details of statistical analysis will be finalized and reported with the statistical analysis plan. Enrollment is targeted to begin in the 3rd quarter of 2025."

Clinical • Combination therapy • P1/2 data • Hematological Malignancies • Multiple Myeloma • IKZF1

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

Optimal infection prophylaxis strategy for relapsed/refractory multiple myeloma patients undergoing elranatamab therapy (OPTIMUS-EL) (ASH 2025) - P2 | "To close the gaps of current guidelines on infection risk mitigation and subsequently BsAb treatment optimization, we aim to investigate the efficacy and safety of letermovir for the prevention of clinically significant CMV infection in patients undergoing elranatamab therapy. Based on one-sample multiple testing procedure for phase II clinical trial (one-sided α error rate 5%, power 90%, p0 39.4 versus p1 17.5), the optimal sample size is 35. Considering the drop-off rate of 10%, 40 patients will be enrolled"

Clinical • Bone Marrow Transplantation • CNS Disorders • Cytomegalovirus Infection • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Ocular Inflammation • Ophthalmology • Pneumonia • Respiratory Diseases • Retinal Disorders

Elranatamab real-world step-up dosing patterns in relapsed-refractory multiple myeloma patients: Interim analysis Results of the AMbreLA study (ASH 2025) - P2 | "It confirms that the adapted ELRA SUD schedule and per-label recommended premedication is associated with good management of CRS and ICANS. More patients with longer follow-up are needed to update these data, as real-world profiles and treatment patterns may evolve over time."

Clinical • Real-world • Real-world evidence • Cardiovascular • Hematological Malignancies • Hypertension • Multiple Myeloma • Renal Disease

Real-world characteristics of patients initiating elranatamab for relapsed/refractory multiple myeloma in the United States (ASH 2025) - "The median duration of index encounter for patients initiating treatment in IP care indicates that patients may be receiving, and hospitalized for, multiple elranatamab treatments in the same encounter. Further longitudinal studies with longer treatment follow-up are warranted to understand evolving treatment settings and RW elranatamab utilization and effectiveness."

Clinical • Real-world • Real-world evidence • Diabetes • Hematological Disorders • Hematological Malignancies • Metabolic Disorders • Multiple Myeloma • Nephrology • Pulmonary Disease • Renal Disease • Respiratory Diseases

Real-world step-up dosing of patients receiving elranatamab for multiple myeloma in Japan (ASH 2025) - "Almost all patients received dexamethasone during the SUD period (Group A: 192 [99.5%], Group A+B: 217 [99.5%]) and acetaminophen (Group A: 191 [99.0%], Group A+B: 216 [99.1%]). Other supportive medications received include diphenhydramine (Group A: 109 [56.5%], Group A+B: 124 [56.9%]) and tocilizumab (Group A: 101 [52.3%], Group A+B: 120 [55.0%])...Both the frequency and timing of CRS and ICANS were generally consistent with past findings from elranatamab clinical trials. Despite the occurrence of CRS and ICANS events, many patients continued to receive complete and timely SUD."

Clinical • Real-world • Real-world evidence • Hematological Malignancies • Inflammation • 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

Comparison of elranatamab's progression-free survival, duration of response, and overall survival from MagnetisMM-3 versus real-world external control arms: A subgroup analysis of China-predominant treatment regimens (ASH 2025) - P2 | "Two China-specific physician's choice of therapy (CSPCT) subgroups were created by identifying patients receiving the predominant treatment regimens in China from the identified COTA cohort (CSPCT1: DVd, D-VMP, DKd, IxaDd, DRd, DPd, DRVd, DVTd; CSPCT2: daratumumab + [either carfilzomib or bortezomib or ixazomib] + any non-IMiD). In unweighted analyses vs CSPCT2, ELRA was associated with longer PFS (mPFS, 17.25 vs 4.93 months; HR, 0.55; 95% CI, 0.34-0.89; P <.05), numerically longer OS (mOS, 24.61 vs 14.95 months; HR, 0.70; 95% CI, 0.46-1.08; P =.11), and longer DOR (mDOR, NR vs 4.70 months; HR, 0.17; 95% CI, 0.07-0.41; P <.05). Conclusions Among BCMA-naive patients with RRMM who resemble those from the MM-3 trial, patients treated with ELRA have better outcomes than patients using the predominant treatment regimens available in China."

Clinical • Real-world • Real-world evidence • Hematological Malignancies • Leukemia • Multiple Myeloma • Plasma Cell Leukemia

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

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 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

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

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

Real-world descriptive analysis of the use of bispecific t cell engagers (BiTEs) in the treatment of hematological malignancies in Qatar: A state-wide retrospective cohort study (ASH 2025) - "Nevertheless, in r/r multiple myeloma (MM) elranatamab and teclistamab have been used to target BCMA. Another BiTE targeting CD20 used in r/r follicular lymphoma (FL) such as mosunetuzumab, and glofitamab in r/r diffuse large B cell lymphoma (DLBCL), while epcoritamab has been approved in both indications (Shouse G., 2025)...Method This is a descriptive retrospective cohort study, including all adult hematological patients who were treated with BiTEs: epcoritamab, glofitamab, blinatumomab, and teclistamab...Despite the small sample size and the study design, our findings nearly comply with primary literature that BiTEs serve as a promising therapeutic alternative for patients with relapsed or refractory disease, particularly those who have exhausted other modalities. However, the high incidence of reported adverse drug reactions (ADRs), including severe toxicities such as CRS and ICANS, highlights the need for robust and careful strategies for safety and tolerability..."

Real-world • Real-world evidence • Retrospective data • Acute Lymphocytic Leukemia • B Cell Lymphoma • Burkitt Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma

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

Real-world response and toxicity profiles of sequential bispecific antibody therapies in Relapsed/Refractory multiple myeloma (ASH 2025) - "We retrospectivelyanalyzed the outcomes and toxicities associated with BsAb sequencing in heavily pretreated RRMM.MethodsWe identified 31 pts with RRMM who received two sequential BsAbs (1st BsAb= BsAb#1, 2nd BsAb=BsAb#2), including teclistamab (Tec), talquetamab (Tal) or elranatamab (Elran) in any order...Most CRS was managed with tocilizumab (BsAb#1: 78%; BsAb#2: 83%); dexamethasone was added in 17% of cases each...A priorepisode of CRS may predict future events, highlighting the need for toxicity risk stratification. Thesefindings support the feasibility of sequential BsAb use and underscore the need for prospective studiesto guide optimal sequencing and supportive care strategies."

Clinical • Real-world • Real-world evidence • Amyloidosis • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Neutropenia

Incidence and risk factors of hemophagocytic lymphohistiocytosis after bispecific antibody therapy in hematologic malignancies: Insights from a global real-world cohort (ASH 2025) - "Clinical trials have limited numbers and maynot capture rare events well, so real-world evidence from large databases is essential.Objectives: This study aimed to (1) estimate the real-world incidence of HLH within 90 days of initiation ofselected bsAbs - blinatumomab, glofitamab, teclistamab, talquetamab, epcoritamab, and elranatamab,(2) identify clinical predictors of HLH development and (3) Assess the impact of HLH occurrence onsurvival outcomes. A retrospective cohort analysis was conducted using the TriNetX Global Network whichincluded data from 202 healthcare organizations, accessed on July 8, 2025. In this large, real-world cohort of patients with hematologic malignancies treated withbsAbs, HLH occurred in approximately 1 in 140 patients within 90 days of therapy initiation. HLH wasassociated with markedly increased mortality during the one-year period following therapy. History ofsevere Infections prior to initiation of bsAbs therapy and baseline laboratory..."

Clinical • Real-world • Real-world evidence • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Immunology • Infectious Disease • Leukemia • Lymphoma • Neutropenia • Oncology • Pneumonia • Rare Diseases • Respiratory Diseases • Septic Shock • Thrombocytopenia