Elrexfio (elranatamab-bcmm) / Pfizer - LARVOL DELTA

Korean Post Marketing Surveillance for ELREXFIO (Elranatamab). (clinicaltrials.gov) - P=N/A | N=150 | Active, not recruiting | Sponsor: Pfizer | Trial completion date: May 2030 ➔ Jan 2030 | Trial primary completion date: May 2030 ➔ Jan 2030

Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Comparison of outcomes with elranatamab and real world treatments in the UK for triple class exposed relapsed and refractory multiple myeloma. (PubMed, BMC Cancer) - "This study provides recent real world evidence of poor outcomes in TCE RRMM in the UK. PFS was longer among patients who received elranatamab compared with treatments for TCE RRMM in routine UK clinical practice."

Clinical • HEOR • Journal • Observational data • Real-world evidence • Retrospective data • Hematological Malignancies • Multiple Myeloma • Oncology

ElLen: Elranatamab/Lenalidomide Consolidation and/or Elranatamab Maintenance Versus Standard of Care After D-VRd Induction in Transplant-eligible NDMM Patients (clinicaltrials.gov) - P3 | N=824 | Recruiting | Sponsor: Intergroupe Francophone du Myelome | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

Safety and Efficacy of Elranatamab in Patients with Relapsed and/or Refractory immunoglobulin Light-Chain Amyloidosis. (PubMed, Blood) - "B cell maturation antigen (BCMA)-targeting bispecific T cell engagers teclistimab and elranatamab have shown high activity and acceptable safety profile in relapsed and/or refractory multiple myeloma patients, leading to their FDA approval. Median time to hematological response was 9 days (6-24), with deep suppression in involved free light chains observed within one cycle of therapy, translating in cardiac and renal responses at 3-6 months. These data support prospective studies exploring Elranatamab in relapsed and/or refractory AL amyloidosis patients."

Journal • Amyloidosis • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology

Elranatamab for Relapsed/Refractory Multiple Myeloma With Severe Renal Impairment Requiring Hemodialysis. (PubMed, Hematol Oncol) - "To illustrate this issue, we introduce the case of a 68-year-old female with triple-class RRMM and end-stage renal disease requiring hemodialysis, treated with elranatamab as a second line treatment following progression after therapy with daratumumab, bortezomib, lenalidomide, and dexamethasone. Despite experiencing grade I cytokine release syndrome during the initial administrations, symptoms were managed effectively with tocilizumab and dexamethasone, allowing treatment continuation...According to the literature, BCMA-directed immunotherapies, including teclistamab, belantamab mafodotin, and idecabtagene vicleucel, have shown efficacy in dialysis-dependent RRMM patients, though data remain limited...By providing real-world evidence for the use of bispecific antibodies in end stage renal disease patients, this review emphasizes the potential for expanding therapeutic options to this vulnerable population while highlighting the need for vigilant monitoring of infection..."

Journal • Chronic Kidney Disease • Hematological Malignancies • Infectious Disease • Inflammation • Multiple Myeloma • Nephrology • Oncology • Renal Disease

Multiple Myeloma Unpacked (ICML 2025) - P3 | "Several other phase II studies have explored the efficacy of triplet regimens incorporating Rd as a backbone, combined with agents such as elotuzumab [30], ixazomib [31], or carfilzomib [32] as well as quadruplet regimen including daratumumab and carfilzomib [33]...The landscape of induction treatment has evolved with the incorporation of the anti-CD38 monoclonal antibody daratumumab (D) into the triplet bortezomib-thalidomide-dexamethasone (VTd) and, more recently, bortezomib-lenalidomide-dexamethasone (VRd)...In transplant-ineligible patients, VRd [45], daratumumab-lenalidomide-dexamethasone (DRd) [46, 47] and daratumumab-bortezomib-melphalan-prednisone (DVMP) [48, 49] have been the standards of cares for years...The FDA approval of isatuximab-bortezomib-lenalidomide-dexamethasone (Isa-VRd), based on the results of the IMROZ study [38], which demonstrated the superiority of Isa-VRd over VRd in terms of MRD negativity and PFS, introduces a new SoC...Consequently,..."

IO biomarker • Hematological Malignancies • Multiple Myeloma • Oncology • Plasmacytoma • Smoldering Multiple Myeloma • B2M • CRBN • CTCs • XPO1

IVIG prophylaxis should be initiated following bispecific antibody therapy in multiple myeloma regardless of IgG levels. (PubMed, Blood Adv) - "Bispecific antibodies (bsAbs) such as teclistamab, elranatamab, linvoseltamab, and talquetamab have impressive efficacy in multiple myeloma (MM) but come with substantial infectious risks that do not dissipate over time. We also discuss strategies to improve the cost-effectiveness of IVIG and SCIG across the world. Given the overwhelmingly favorable benefit-risk profile of IgRT coupled with the limitations inherent to IgG measurements in MM, withholding IgRT access based on arbitrary IgG thresholds is neither scientifically sound nor clinically appropriate for patients with MM receiving bsAb therapy."

Journal • Hematological Malignancies • Multiple Myeloma • Oncology

Resistance Mechanisms to BCMA Targeting Bispecific Antibodies and CAR T-Cell Therapies in Multiple Myeloma. (PubMed, Cells) - "In this review, we examine the current landscape of BCMA-directed therapies, including Idecabtagene Vileucel, Ciltacabtagene Autoleucel, Teclistamab, and Elranatamab and explore the multifactorial mechanisms driving resistance. Additionally, we discuss the role of therapy sequencing, emphasizing how prior exposure to BsAbs or CAR T-cell therapies may influence the efficacy of subsequent treatments. A deeper understanding of resistance biology, supported by integrated immune and genomic profiling, is essential to optimizing therapeutic durability and ultimately improve patient outcomes for patients with MM."

Journal • Review • 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...Unfortunately, the FGF23 in this patient is hard to interpret given it was drawn after calcitriol was started which may have stimulated FGF23. Clinicians should be aware of the association between myeloma and elevated FGF 23 levels and how this can impact electrolytes and bone homeostasis."

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

Emerging therapeutic agents in multiple myeloma: highlights from the 2024 ASH annual meeting. (PubMed, Biomark Res) - "Key updates include: Cevostamab (FcRH5×CD3) demonstrated a 30.2% overall response rate in patients who underwent BCMA-targeted treatment and 60.6% in BCMA-targeted naïve patients;the triple-step dosing strategy reduced cytokine release syndrome. Lisaftoclax (APG-2575, BCL-2 inhibitor) displayed overall response rates ranging from 61.3 to 100% and ≥ VGPR rates of 32.3-100%, supporting enhanced response depth with favorable safety in combination regimens. Inobrodib (CCS1477, p300/CBP inhibitor) plus lenalidomide achieved a 71% overall response rate in pomalidomide-refractory patients, marking the first oral epigenetic modulator to reverse immunomodulatory drug resistance. Elranatamab (ELRA, BCMA×CD3) combined with carfilzomib and dexamethasone yielded an 83.3% overall response rate with a median duration of response not reached. Mezigdomide (MEZI, CELMoD) showed an 85.7% overall response rate and 17.5-month progression-free survival in..."

Journal • Hematological Malignancies • Inflammation • Multiple Myeloma • Oncology

Pfizer’s Elranatamab Study: A New Hope for Multiple Myeloma Treatment in Korea (The Globe and Mail) - "Pfizer Inc. is conducting a Korean Post Marketing Surveillance study for ELREXFIO (Elranatamab) to evaluate its safety and effectiveness in treating multiple myeloma in real-world clinical settings. This observational study aims to gather data on Elranatamab’s performance under general clinical practice conditions in Korea, following the MFDS guidelines. The study is designed as an open-label, multi-center, non-comparative, observational cohort study. It focuses on assessing the drug’s safety and effectiveness without any masking or allocation, aligning with standard clinical practices. The study commenced on June 5, 2025, with its primary completion and estimated completion dates yet to be determined. The last update was submitted on July 1, 2025, indicating ongoing progress."

Trial status • Multiple Myeloma

“A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of elranatamab compared with the current standard of care, on the basis of the proposed price relative to currently available therapies.” [For multiple myeloma] (National Centre for Pharmacoeconomics, Ireland)

HEOR • Hematological Malignancies • Multiple Myeloma • Oncology

“The NCPE recommends that elranatamab (Elrexfio) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments” [For multiple myeloma] (National Centre for Pharmacoeconomics, Ireland)

Reimbursement • Hematological Malignancies • Multiple Myeloma • Oncology

Tocilizumab Prophylaxis for Patients with Multiple Myeloma Treated with Bispecific Antibodies. (PubMed, Blood Adv) - "For teclistamab, elranatamab, linvoseltamab and talquetamab individually, the CRS rate was 8.9%, 12.5%, 0%, and 13%. There were no grade 3 CRS events, and no additional doses of tocilizumab or corticosteroids were given for CRS. Our real-world evidence results suggest that tocilizumab may be effective as a preventative, rather than reactive, measure to prevent CRS without compromising efficacy."

Journal • Hematological Malignancies • Inflammation • Multiple Myeloma • Oncology

NAVIGATING THE STORM: SEVERE CYTOKINE RELEASE SYNDROME IN A PATIENT WITH REFRACTORY AL AMYLOIDOSIS TREATED WITH ELRANATAMAB (CHEST 2025) - No abstract available

Clinical • Cytokine release syndrome • Amyloidosis • Inflammation

FASTER: Frontline T-cell Engager vs Autologous Stem Cell Transplant (ASCT) and Measurable Residual Disease (MRD)-Guided Sequential Intensification thERapy in Multiple Myeloma (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: SCRI Development Innovations, LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

Korean Post Marketing Surveillance for ELREXFIO (Elranatamab). (clinicaltrials.gov) - P=N/A | N=150 | Active, not recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Hematological Malignancies • Multiple Myeloma • Oncology

COMBINING BISPECIFICS AND RADIATION FOR REL/REF HEMATOLOGIC MALIGNANCIES: FRIEND OR FOE? (ICML 2025) - "BsAbs administered for LBCL were glofitamab (n = 5) and epcoritamab (n = 2), while those for MM included elranatamab (n = 10), teclistamab (n = 5), and talquetamab (n = 4). We report our early experience using RT in combination with BsAbs, highlighting its safety, feasibility, and excellent local control rates, even in bulky sites. Longer follow-up with larger cohorts is needed to assess the durability of response and the dose-response relationship."

B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

REAL-WORLD EXPERIENCE OF CYTOKINE RELEASE SYNDROME AND INFECTION INCIDENCE POST-ELRANATAMAB THERAPY IN AN NHS TERTIARY CENTRE: A CASE SERIES (EHA 2025) - "No grade ≥ 3 CRS was observed; CRS resolved rapidly with supportive measures and tocilizumab. CRS incidence in our cohort was markedly higher than in both the prospective phase 2 MagnetisMM3 trial, and retrospective European real-world data, despite corticosteroid delivery in line with the trial protocol. Infection rates compare favorably with European and USA real-world cohorts treated with both elranatamab and teclistamab. Cognizant of the constraints of a small dataset, while the mechanistic underpinnings of baseline ANC correlating with CRS grade is biologically intuitive, it is pertinent to note that ∆iFLC/∆t did not positively predict CRS in this sample."

Clinical • Cytokine release syndrome • Real-world • Real-world evidence • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Malignancies • Hypertension • Infectious Disease • Inflammation • Lymphoma • Multiple Myeloma • Oncology • TP53

THE EFFICACY OF ELRANATAMAB IN MAGNETISMM-3 COMPARED WITH A REAL-WORLD CONTROL ARM SIMULATING A COLOMBIAN TRIPLE-CLASS REFRACTORY MULTIPLE MYELOMA POPULATION (EHA 2025) - P2 | "The main treatment regimens used in the RW cohort were daratumumab, pomalidomide, and dexamethasone (17.5%); carfilzomib, dexamethasone, and cyclophosphamide (11.7%); carfilzomib and dexamethasone (11.7%); carfilzomib, pomalidomide, and dexamethasone (11.7%). Elranatamab was associated with significantly longer PFS and DOR versus patients treated with standard regimens available in Colombia. The OS rate was numerically favorable for elranatamab, but not statistically significant."

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

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 (EHA 2025) - P3 | "Aims: To describe the design of the MagnetisMM-32 study (NCT06152575), a phase 3, open-label, multicenter, randomized study to 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..."

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

AN INDIRECT COMPARISON OF ELRANATAMAB'S PATIENT-REPORTED OUTCOMES FROM MAGNETISMM-3 VERSUS REAL-WORLD EXTERNAL CONTROL ARMS IN TRIPLE-CLASS REFRACTORY MULTIPLE MYELOMA (EHA 2025) - P2 | "Although caution should be applied when comparing clinical trial data with real-world data, we found that patients treated with ELRA in the MM-3 trial exhibited comparable, if not superior, symptom and quality of life experiences compared with similar patients treated with physician's choice of therapy in real-world clinical practice. These results were consistent with previously published clinical efficacy comparisons between MM-3 and RWD sources."

Clinical • Patient reported outcomes • Real-world • Real-world evidence • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology • Pain • Plasma Cell Leukemia

TRIAL IN PROGRESS: PHASE I/II STUDY OF MEZIGDOMIDE AND ELRANATAMAB FOR RELAPSED/ REFRACTORY MULTIPLE MYELOMA PATIENTS (MELT-MM) (EHA 2025) - P1/2 | "Participants will receive mezigdomide at RP2D -1 dose until confirmed PD by investigator, unacceptable toxicity as assessed by the investigator and/or withdrawal of consent (Figure A).Key inclusion criteria include age ≥ 19 years with ECOG performance status ≤ 2, and measurable disease, 2 prior lines of antimyeloma therapy including lenalidomide and at least 1 proteasome inhibitor. As of January 19, 2025, 3 patients have been enrolled to Part 1 Cohort 1. This trial is registered at ClinicalTrials.gov (NCT06645678)."

Clinical • IO biomarker • P1/2 data • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Oncology • IKZF1

SYSTEMATIC REVIEW OF BISPECIFIC ANTIBODIES EFFICACY AND SAFETY IN RELAPSED/REFRACTORY MULTIPLE MYELOMA (EHA 2025) - "BCMA-targeting BsAbs include elranatamab (MagnetisMM-3, MagnetisMM-5, MagnetisMM-9), teclistamab (MajesTEC-1), and linvoseltamab (LINKER-MM1). BsAbs are a promising advancement in the treatment of R/RMM. Currently, three BsAbs - teclistamab (MajesTEC-1), talquetamab (MonumenTAL-1), and elranatamab (MagnetisMM-3)- have received accelerated FDA approval. However, BsAbs are associated with safety concerns, including cytokine release syndrome, hematologic toxicity, and an increased risk of infections."

Clinical • Review • Anemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Neutropenia • Oncology • Thrombocytopenia

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 (EHA 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 patients with transplant-ineligible (TI) NDMM. In patients with TI NDMM, EDR demonstrated a manageable safety profile consistent with the known toxicities of components. High response rates and early responses were observed. Enrollment in dose level H evaluating the ER combination is ongoing."

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