Elrexfio (elranatamab-bcmm) / Pfizer - LARVOL DELTA

"Renewed early access authorization for the specialty ELREXFIO (elranatamab) in the indication As monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior treatments…"[Google translation] (Haute Autorité de santé)

European regulatory • Hematological Malignancies • Multiple Myeloma • Oncology

Suspected Fibroblast Growth Factor 23 Mediated Hypophosphatemia in a Patient with Multiple Myeloma (ENDO 2025) - "FGF 23 levels can be elevated in multiple myeloma, which can contribute to dysregulation of phosphate metabolism and lead to tumor induced osteomalacia [1].CASE PRESENTATIONA 68-year-old male with a history of relapsed multiple myeloma presented for elective bispecific T-cell engager (BiTE) therapy with Elranatamab step-up dosing...2023; 15(6):e40487. Published 2023 Jun 15."

Clinical • Endocrine Disorders • Hematological Malignancies • Multiple Myeloma • Oncology • Renal Disease • FGF23

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

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

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

Implementing the bispecific outpatient safe step-up (BOSS) program for elranatamab in ambulatory treatment of multiple myeloma. (ASCO 2025) - "Patients did not receive tocilizumab prophylactically. Our outpatient elranatamab SUD strategy is safe and feasible for RRMM patients through careful patient selection, dexamethasone alone for CRS prophylaxis, close toxicity monitoring, and prompt hospitalization. This approach reduces inpatient stays and alleviates healthcare resource burdens, enhancing patient experience. Baseline disease and characteristics of CRS: Elranatamab BOSS vs iSUD*17p13 deletion, t(4; 14), t(14; 16), t(14; 20), gain or amplification 1q."

Clinical • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Oncology

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

Elranatamab in combination with daratumumab and lenalidomide (EDR) in patients with newly diagnosed multiple myeloma (NDMM) not eligible for transplant: Initial results from MagnetisMM-6 part 1. (ASCO 2025) - P3 | "MagnetisMM-6 (NCT05623020) is a phase 3, open-label, randomized study evaluating the efficacy and safety of ELRA in combination with lenalidomide (R) ± daratumumab (DARA) (EDR or ER) vs DARA + R + dexamethasone (DRd) in pts with transplant-ineligible (TI) NDMM. In pts with TI NDMM, EDR demonstrated a manageable safety profile consistent with the known toxicities of components. High response rate and early responses were observed. Enrollment in dose level H evaluating the ER combination is ongoing."

Clinical • Combination therapy • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Oncology • Pneumonia • Respiratory Diseases • Transplantation

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

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

Efficacy and safety of less frequent dosing with elranatamab (ELRA) in patients with relapsed or refractory multiple myeloma (RRMM): A US subgroup analysis from MagnetisMM-3. (ASCO 2025) - P2 | "The pts with RRMM enrolled in MagnetisMM-3 Cohort A, including the US subgroup, were heavily pretreated. Consistent with overall Cohort A data, ELRA was associated with deep, durable responses in the US subgroup, with a mPFS of 27.3 mo. CRS was G1 and G2 only."

Clinical • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Oncology • Pneumonia • Respiratory Diseases

MagnetisMM-32: A phase 3 randomized study of elranatamab vs EPd, PVd, or Kd in patients with relapsed or refractory multiple myeloma (RRMM) and prior anti-CD38–directed therapy. (ASCO 2025) - P3 | "This study will evaluate ELRA monotherapy vs elotuzumab-pomalidomide-dexamethasone (EPd), pomalidomide-bortezomib-dexamethasone (PVd), or carfilzomib-dexamethasone (Kd) in patients with RRMM to determine whether ELRA can provide superior clinical benefit in early relapse (2L+)...Key inclusion criteria include age of ≥18 years, prior multiple myeloma diagnosis with measurable disease (per IMWG criteria), evidence of progressive disease or failure to achieve a response to last line of multiple myeloma therapy, 1 to 4 prior lines of therapy including an anti–CD38 antibody–containing regimen (for ≥2 consecutive cycles) and a lenalidomide-containing regimen (for ≥2 consecutive cycles), adequate bone marrow function, and an ECOG performance status of ≤2...The primary endpoint and OS will be compared statistically between treatment arms by stratified log-rank tests. Study funding: Pfizer."

Clinical • P3 data • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Multiple Myeloma • Oncology • Pain

Indirect comparison of linvoseltamab versus elranatamab for triple-class exposed (TCE) relapsed/refractory multiple myeloma (RRMM). (ASCO 2025) - "Linvoseltamab demonstrated significantly higher ORR and ≥CR rate, numerically better ≥ VGPR rate, DOR, PFS, and OS compared with elranatamab, though the follow-up was shorter. These results highlight the potential of linvoseltamab as a highly effective treatment option for TCE RRMM. OR >1 or HR <1 favor linvoseltamab."

Hematological Malignancies • Multiple Myeloma • Oncology

MagnetisMM-30: A phase 1b, open-label study of elranatamab in combination with iberdomide in patients with relapsed or refractory multiple myeloma (RRMM). (ASCO 2025) - P1 | "Key exclusion criteria are pts with stem cell transplant ≤12 weeks prior to enrollment; active, uncontrolled infection; prior treatment with BCMA-directed or CD3 redirecting therapy or prior CELMoD agents (ie, IBER or mezigdomide)...Secondary endpoints include AEs and lab abnormalities (Part 1 only), ORR, CRR, time-to-event outcomes, pharmacokinetics, minimal residual disease negativity rate, and immunogenicity. This study is ongoing; Part 1 and Part 2 will enroll up to approximately 36 and 60 pts, respectively."

Clinical • Combination therapy • P1 data • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Oncology

Unmet Needs in Relapsed/Refractory Multiple Myeloma: Considering a BCMA-Directed Bispecific Antibody (COMy 2025) - "Sponsored by Pfizer This program will explore key findings from a large global survey of health care providers and patients, uncovering unmet needs in patient care and key barriers to adoption of immunotherapies for relapsed/refractory multiple myeloma. Current treatment options, including practical considerations for the use of elranatamab, a BCMA-directed bispecific immunotherapy for certain adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, will also be discussed."

Hematological Malignancies • Multiple Myeloma • Oncology

MAGNETISMM-3: long-term update and outcomes of less frequent dosing of elranatamab in relapsed/refractory multiple myeloma (RRMM) (COMy 2025) - No abstract available

Hematological Malignancies • Multiple Myeloma • Oncology

MAGNETISMM-20: EFFICACY AND SAFETY OF ELRANATAMAB PLUS CARFILZOMIB AND DEXAMETHASONE (EKD) FOR RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM) (COMy 2025) - No abstract available

Clinical • Hematological Malignancies • Multiple Myeloma • Oncology

ERd Combination Treatment in Newly Diagnosed Multiple Myeloma (clinicaltrials.gov) - P2 | N=104 | Not yet recruiting | Sponsor: University of Miami

New P2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

ASCO 2025: Adding Elranatamab to Daratumumab, Lenalidomide Induces Durable Responses in Newly Diagnosed Multiple Myeloma (Pharmacy Times) - P3 | N=966 | MagnetisMM-6 (NCT05623020) | Sponsor: Pfizer | "The confirmed overall response rate (ORR) was 91.9% (95% CI, 78.1–98.3), with 81.1% of patients achieving a very good partial response (VGPR) or better. Among patients who were enrolled at least 4 months prior to the data cutoff (n = 23), the confirmed ORR was 95.7% (95% CI, 78.1–99.9), with all patients achieving a VGPR or better....Treatment-emergent adverse events (TEAEs) were manageable. The researchers reported TEAEs in 97.3% of patients, hematological TEAEs in 78.4%, and infections in 64.9%."

P3 data • Multiple Myeloma

A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination With Elranatamab in Participants With Relapsed and/or Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=62 | Not yet recruiting | Sponsor: Celgene

New P1/2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

INDIRECT COMPARISON OF LINVOSELTAMAB VERSUS ELRANATAMAB FOR TRIPLE-CLASS EXPOSED RELAPSED/REFRACTORY MULTIPLE MYELOMA (EHA 2025) - P1/2, P2 | "Compared with patients receiving elranatamab, patients receiving linvoseltamab demonstrated significantly higher ORR and ≥CR rate, numerically better ≥VGPR rate, and longer DOR, PFS, and OS, though the follow-up period was shorter. These results highlight the potential of linvoseltamab as a highly effective treatment option for patients with TCE RRMM."

Hematological Malignancies • Multiple Myeloma • Oncology

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Antiemesis, Version 2.2025. (NCCN)

NCCN guideline • Multiple Myeloma • Oncology • Solid Tumor

Non Interventional Study to Investigate the Safety and Effectiveness in Patients With Relapsed and Refractory Multiple Myeloma Treated With Elranatamab Under the Actual Use. (clinicaltrials.gov) - P=N/A | N=1 | Active, not recruiting | Sponsor: Pfizer | Trial completion date: Apr 2028 ➔ Feb 2027 | Trial primary completion date: Apr 2028 ➔ Feb 2027

Trial completion date • Trial primary completion date • 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