Elrexfio (elranatamab-bcmm) / Pfizer - LARVOL DELTA

Ambulatory Elranatamab Step-Up is Safe and Deliverable: The Leeds Teaching Hospitals Experience (BSH 2025) - No abstract available

Clinical • Amyloidosis • Hematological Malignancies • Multiple Myeloma • Oncology • Plasmacytoma

IFM 2024_06: Comparison of Elranatamab and Lenalidomide Versus Daratumumab and Lenalidomide as Post-transplant Maintenance Therapy in Patients With Newly Diagnosed Myeloma (clinicaltrials.gov) - P2 | N=176 | Not yet recruiting | Sponsor: Nantes University Hospital

New P2 trial • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

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 | Not yet recruiting | Sponsor: Intergroupe Francophone du Myelome

New P3 trial • Bone Marrow Transplantation • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

MagnetisMM-5: Study of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P3 | N=759 | Active, not recruiting | Sponsor: Pfizer | Trial primary completion date: Aug 2025 ➔ Dec 2025

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

A Study to Learn About the Effectiveness of the Medicine Called Elranatamab in People With Relapsed Refractory Multiple Myeloma as Compared With Standard of Care Therapies (clinicaltrials.gov) - P=N/A | N=1 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

HEOR • Real-world evidence • Trial completion • Hematological Malignancies • Multiple Myeloma • Oncology

Economic Impact of Elranatamab for Treatment of Patients with Relapsed or Refractory Multiple Myeloma. (PubMed, Clinicoecon Outcomes Res) - "Total cost of care per month of median PFS over one year was $19,642 with elranatamab, talquetamab ($33,391), teclistamab ($37,791), selinexor plus dexamethasone ($48,784), physician's choice of treatment ($65,886), idecabtagene vicleucel ($78,361), and ciltacabtagene autoleucel ($17,640). Elranatamab for RRMM is projected to result in a minimal to small budget impact over 3 years and good economic value with lower cost of care per month of PFS compared with other available RRMM treatments except for ciltacabtagene autoleucel."

HEOR • Journal • Hematological Malignancies • Multiple Myeloma • Oncology

OPTIMUS-EL: Phase II Trials of Letermovir Prophylaxis in Patients With RRMM Undergoing Elranatamab Therapy (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Seoul National University Hospital

New P2 trial • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Oncology

Cost-Effectiveness of Elranatamab Versus Current Therapies for the Management of Patients with Triple-Class Exposed, Relapsed and Refractory Multiple Myeloma, Including Other Bispecific and Physician's Choice of Treatment in Spain. (PubMed, Oncol Ther) - "Elranatamab is a cost-effective treatment versus PCT and dominant over teclistamab for the treatment of adult patients with TCE-RRMM in the Spanish setting."

HEOR • Journal • Hematological Malignancies • Multiple Myeloma • Oncology

Elranatamab versus physician's choice of treatment in patients with triple-class exposed/refractory multiple myeloma: an updated matching-adjusted indirect comparison. (PubMed, J Comp Eff Res) - P, P2 | "The robustness of the results was demonstrated in sensitivity analyses in which missing baseline characteristics data for elranatamab were imputed. Overall, the findings of this study align with and add confidence to the conclusions of the previous MAIC that elranatamab is associated with significantly improved outcomes versus standard treatment, supporting the value to elranatamab for the treatment of patients with triple-class exposed/refractory multiple myeloma."

Journal • Hematological Malignancies • Multiple Myeloma • Oncology

AN AUDIT ON THE INCIDENCE OF HYPOGAMMAGLOBULINEMIA AND INITIATION OF IMMUNOGLOBULIN REPLACEMENT IN MULTIPLE MYELOMA PATIENTS RECEIVING BISPECIFIC ANTIBODY TREATMENT (EBMT 2025) - "Talquetamab is currently accessible through a compassionate use program since 2022. The incidence of hypogammaglobulinemia was notably high across all three BsAbs used in MM. Immunology referrals did not necessarily correlate with those patients who experienced hypogammaglobulinemia, and not all patients that had IgG levels below 4 g/L were commenced on IGRT. When compared to data from clinical trials, the utilisation of IGRT was relatively low for Teclistamab and Elranatamab."

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

EMBRACE: Outpatient and Intermittent Dosing of Elranatamab in Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Ontario Clinical Oncology Group (OCOG) | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

Korean hematologists urge faster reimbursement for lifesaving blood cancer drugs (Korea Biomedical Review) - "The Korean Society of Hematology (KSH) has voiced strong concerns over delays in the reimbursement of newly approved therapies for blood cancer patients...While novel agents such as CAR-T therapies and bispecific antibodies are offering new hope to patients with relapsed or refractory multiple myeloma, lymphoma, and acute leukemia, many of these drugs remain financially out of reach due to protracted insurance evaluations....Several bispecific antibodies — including Tecvayli, Elrexfio, and Talvey — have received accelerated approvals from both the U.S. FDA and the Ministry of Food and Drug Safety based on promising results from phase 2 clinical trials....The same issue is affecting patients with lymphoma, where drugs such as Epkinly and Columvi...face similar reimbursement delays despite being recognized for their clinical benefit in high-risk, treatment-resistant cases."

Reimbursement • Lymphoma • Multiple Myeloma

Use of Novel Therapies for Multiple Myeloma in the United States: Important Differences in Patient Characteristics, Access to Care, and Real-World Treatment Challenges (ISPOR 2025) - "All pts had ≥1 claim for a CAR-T/BsAb tx including idecabtagene vicleucel, ciltacabtagene autoleucel, teclistamab, talquetamab, or elranatamab, and continuous enrollment ≥90 days before and after index date. Of the 2,442 pts included, 61% received BsAbs and 39% received CAR-Ts. Descriptively, these results suggest important differences in sociodemographic and clinical characteristics among pts who received novel tx for MM. Uptake of BsAbs was higher compared to CAR-Ts, indicating greater tx accessibility for BsAbs. This warrants further investigation into barriers to access and strategies to potentially ameliorate existing health disparities in U.S. MM pts."

Clinical • HEOR • Real-world • Real-world evidence • 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

From Bias to Confidence: Exploring Quantitative Bias Analysis' (QBA's) Role in Matching Adjusted Indirect Treatment Comparison (ISPOR 2025) - "This study illustrates how QBA can ascertain the robustness of MAIC findings despite missingness and confounding by estimating the bias strengths required to nullify study conclusions. A previously published MAIC between elranatamab and the real-world LocoMMotion study in patients with triple-class exposed multiple myeloma was used as a case study... QBA can evaluate the impact of bias due to missing values or unmeasured confounders and assess the severity of these evidence gaps quantitatively. When the bias is estimated to be small, it enhances confidence in the conducted MAICs for decision-making."

Hematological Malignancies • Multiple Myeloma • Oncology

Real-World Healthcare Resource Utilization and Costs Associated with Elranatamab Initiation in Multiple Myeloma: the ALTITUDE-1 Study (ISPOR 2025) - "While the total costs of care remain roughly stable after the initiation of ELRA, the categories of costs evolve. Interestingly, pharmacy costs decreased after ELRA initiation."

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

Unveiling cardiovascular and respiratory toxicities with monoclonal antibodies in multiple myeloma: disproportionality analysis from the FDA Adverse Event Reporting System. (PubMed, Eur J Clin Pharmacol) - "Unexpected CV and respiratory AEs with clinical relevance not previously reported in literature have been identified underlining the importance of pharmacovigilance."

Adverse events • Journal • Atrial Fibrillation • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology • Pulmonary Embolism • Respiratory Diseases

MAGNETISMM-7: AN OPEN-LABEL, MULTICENTER, RANDOMIZED PHASE 3 STUDY OF ELRANATAMAB VERSUS LENALIDOMIDE AFTER TRANSPLANT IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA (EBMT 2025) - P3 | "N/A - Trial in progress Clinical Trial Registry: NCT05317416"

Clinical • IO biomarker • P3 data • Amyloidosis • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Multiple Myeloma • Oncology • Plasma Cell Leukemia • Rare Diseases • Transplantation • Waldenstrom Macroglobulinemia

“Update of section 4.2 of the SmPC to add every four-week dosing schedule after at least 24 weeks of every two-week dosing and to update the recommendations for restarting therapy…update of sections 4.8, 5.1 and 5.2 of the SmPC with long-term efficacy, safety, and clinical pharmacology results…based on Study C1071003…” (European Medicines Agency) - Pharmacovigilance Risk Assessment Committee (PRAC)-Draft agenda for the meeting on 10 - 13 Mar 2025: “For adoption of PRAC RMP AR, PRAC RMP assessment overview and advice to CHMP”

PRAC • Hematological Malignancies • Multiple Myeloma • Oncology

NMPA approves Pfizer's CD3/BCMA dual antibody for marketing [Google translation] (Sina Corp) - "On March 10, Pfizer announced that the CD3/BCMA dual antibody Elranatamab (trade name: Ireo) was conditionally approved for marketing by the National Medical Products Administration for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who had previously received at least three treatments (including a proteasome inhibitor, an immunomodulator and an anti-CD38 monoclonal antibody). The approval was mainly based on the positive data from the single-arm Phase II MagnetisMM-3 study and the separate Phase Ib/II single-arm MagnetisMM-8 study in China."

China approval • Multiple Myeloma

Treatment of Multiple Myeloma in Patients Refractory to Daratumumab/Anti-CD38 Monoclonal Antibodies: A Systematic Review. (PubMed, Cancer Med) - "Based on the results of this systematic review, BCMA-directed therapies such as CAR-T cell therapy and bispecific antibodies demonstrate promising efficacy among patients with anti-CD38 refractory disease. However, additional evidence from randomized clinical trials is necessary to establish best practice guidelines."

Clinical • Journal • Review • Hematological Malignancies • Multiple Myeloma • Novel Coronavirus Disease • Oncology • Targeted Protein Degradation • CRBN

Update on B-cell maturation antigen-directed therapies in AL amyloidosis. (PubMed, Br J Haematol) - "The standard-of-care first-line therapy is a combination of daratumumab, cyclophosphamide, bortezomib and dexamethasone (D-VCd regimen), resulting in high rates of haematological and organ responses...Recently, several novel anti-BCMA immunotherapies have been approved for the treatment of relapsed/refractory MM, including antibody-drug conjugate belantamab mafodotin, bispecific antibodies teclistamab and elranatamab and chimeric antigen receptor T-cell therapies idecabtagene vicleucel and ciltacabtagene autoleucel. Despite lower expression than in MM, BCMA is also a promising target in AL amyloidosis. This review aims to provide up-to-date information on the efficacy and toxicity of anti-BCMA therapy in AL amyloidosis."

IO biomarker • Journal • Review • Amyloidosis • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology

EMBRACE: Outpatient and Intermittent Dosing of Elranatamab in Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Ontario Clinical Oncology Group (OCOG) | Initiation date: Nov 2024 ➔ May 2025 | Trial primary completion date: Dec 2025 ➔ Dec 2026

IO biomarker • Trial initiation date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

ERICA: Self-administration of Subcutaneous Elranatamab in the Patients' Homes. (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Thomas Lund | Not yet recruiting ➔ Recruiting | Trial completion date: Jan 2026 ➔ Jul 2027 | Trial primary completion date: Jan 2025 ➔ Jul 2026

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

NIMMS: The Norwegian Immunotherapy in Multiple Myeloma Study (clinicaltrials.gov) - P=N/A | N=400 | Recruiting | Sponsor: St. Olavs Hospital

New trial • Amyloidosis • Hematological Malignancies • Leukemia • Multiple Myeloma • Oncology • Plasma Cell Leukemia