Epkinly (epcoritamab-bysp) / Genmab, AbbVie - LARVOL DELTA

Real World Experience of Glofitamab and Epcoritamab: A Retrospective U.K. Multicentre Analysis (BSH 2025) - No abstract available

Real-world • Real-world evidence • Retrospective data • Chronic Lymphocytic Leukemia • Hematological Malignancies • Lymphoma • Oncology

SPRING: Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Peking University Shenzhen Hospital

Biomarker • New P2 trial • Oncology

CSF1R-targeting T cell engaging bispecific antibodies for Acute Myeloid Leukemia treatment (ITOC 2025) - "Background The potential of T-cell engaging bispecific antibodies (TCEs) is illustrated by the success of targeting CD19 (Blinatumomab) and CD20 (Epcoritamab, Glofitamab, Mosuenetuzumab) in relapsed and refractory B-cell non-Hodgkin lymphoma. However, in AML, TCEs targeting CD33 (JNJ-67571244, AMG330) and CD123 (Vibecotamab) have shown low efficacy and high toxicity...Consistent with our single-cell RNA sequencing-based target analysis, the CSF1R-TCE exhibited a superior safety profile than the CD33-TCE while maintaining anti-tumor activity. CSF1R-targeting TCEs may represent a novel immunotherapeutic approach for AML with high translative potential."

Acute Myelogenous Leukemia • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD123 • CD33 • CD34 • CSF1R • IL3RA

An evaluation of epcoritamab as a treatment for relapsed or refractory follicular lymphoma. (PubMed, Expert Rev Anticancer Ther) - "the optimal treatment sequencing in FL is still an open issue, however epcoritamab effectively combines key aspects such as high, rapid and durable responses, good tolerability, predictable cytokine release syndrome (CRS) kinetics, and ease of administration, representing an appealing option for patients and clinicians. Future efforts should aim at positioning epcoritamab-based treatments in earlier lines of FL."

Journal • Review • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Oncology • CD20

E-REVRI: Study of Epcoritamab in Relapsed and Refractory Primary Diffuse Large B-cell Lymphoma of the CNS Treated With Lenalidomide and Rituximab (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: The Lymphoma Academic Research Organisation

New P2 trial • B Cell Lymphoma • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Central Nervous System Lymphoma

Modeling and simulation of CRS events in low-risk populations with a rapid ramp-up SUD regimen of epcoritamab (AACR 2025) - "Shortening the SUD to 1 week in patients at low risk for CRS (eg, patients with prior CAR T) resulted in a similar G≥2 CRS rate compared with the current SUD regimen, as predicted by the model. Based on these simulations, a 1-week rapid ramp-up SUD may be beneficial in selected patients to deliver the target full dose of epcoritamab in a shorter time without undue risk. Further confirmation of this finding in clinical studies may be warranted."

Clinical • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

EPCORE CLL-1: Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome (clinicaltrials.gov) - P1/2 | N=424 | Recruiting | Sponsor: Genmab | N=304 ➔ 424

Enrollment change • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Richter's Syndrome • Small Lymphocytic Lymphoma • CD20

EVOLVE205, a dual (2:1) CD20 targeted CD3 trispecific T cell engager with CD2 costimulation for the treatment of B cell malignancies and B cell autoimmune disorders (AACR 2025) - "T cell engager (TCE) CD3-bispecifics have improved the treatment of patients with B cell lymphomas leading to recent approvals of the CD20-targeted CD3 bispecifics including Glofitamab, Mosunetuzumab, and Epcoritamab for patients with relapsed, refractory diseases...Importantly, in a B-cell depleted PBMC-HT tumor co-culture assay, the tumor-killing potency of EVOLVE205 was improved by up to 70-fold compared to Glofitamab, and by over 1,000-fold compared to anti-CD20 mAbs such as Rituximab...It also demonstrates significant in vivo efficacy and a favorable developability profile. Our data indicated that EVOLVE205 with integrated CD2 co-stimulation offers greater efficacy and safety advantages compared to clinically available CD20-targeted TCE therapies and anti-CD20 mAbs for the treatment of B cell lymphomas and for B cell-mediated autoimmune diseases."

Trispecific • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Development of a humanized mouse model for γδT cells (AACR 2025) - "We demonstrate that various γδT cell populations, including Vδ1 and Vδ2, can be successfully maintained over a long period of time, preserving the expression of critical functional biomarkers such as NKG2D, CD69 or CD16, under various engraftment conditions. Additionally, we showed that hu γδT cells display functional engagement in vivo, achieving high efficacy with epcoritamab (CD20-CD3 Ab) against disseminated tumors in the hu γδT cell adoptive transfer mouse model."

IO biomarker • Preclinical • Hematological Malignancies • Oncology • CD20 • CD69 • IL15 • NKG2D

Epcoritamab and Rituximab for First-line Follicular Lymphoma (clinicaltrials.gov) - P2 | N=35 | Active, not recruiting | Sponsor: Reid Merryman, MD | Recruiting ➔ Active, not recruiting | Trial primary completion date: Feb 2026 ➔ Feb 2027

Enrollment closed • Trial primary completion date • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

Epcoritamab for Relapsed or Refractory Follicular Lymphoma (ASCO 2025) - No abstract available

Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

Glofitamab results in cost savings versus epcoritamab in relapsed/refractory diffuse large B-cell lymphoma: a total cost of care analysis‡. (PubMed, Leuk Lymphoma) - P1/2 | "While adverse event ($364) and treatment administration ($8,398) costs were higher for glofitamab versus epcoritamab, these were offset by consistently lower glofitamab treatment costs across all time horizons. Glofitamab showed per-patient TCC savings versus epcoritamab at every cumulative cycle and across all time horizons investigated, offering greater budget predictability and cost savings at the healthcare system and population levels."

HEOR • Journal • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Real-World Study to Assess Subcutaneous Epcoritamab in Adult Participants With Diffuse Large B-Cell and Follicular Lymphoma (clinicaltrials.gov) - P=N/A | N=700 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Enrollment open • Real-world evidence • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

EPCOR+LONCA: Epcoritamab in Combination With Loncastuximab Tesirine in Relapsed/Refractory Large B-cell Lymphoma (clinicaltrials.gov) - P2 | N=26 | Not yet recruiting | Sponsor: University of Miami

New P2 trial • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

FPT2003: Subcutaneous and Chemo-Free: Epcoritamab across Relapsed Refractory Diffuse Large B Cell Lymphoma Patients (EHA 2025) - "Sponsored by Abbvie Inc.,"

Clinical • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Subcutaneous and Chemo-Free: Epcoritamab across Relapsed Refractory Diffuse Large B Cell Lymphoma Patients (EHA 2025) - "Sponsored by Abbvie Inc.,"

Clinical • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Budget impact of introducing glofitamab for treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy in the United States. (PubMed, J Med Econ) - "Comparators were axicabtagene ciloleucel (Axi-cel), lisocabtagene maraleucel (Liso-cel), tisagenlecleucel (Tisa-cel), loncastuximab tesirine, polatuzumab vedotin + bendamustine + rituximab, rituximab + gemcitabine + oxaliplatin, tafasitamab + lenalidomide, and epcoritamab (Epcor). Across all sensitivity analyses, the inclusion of glofitamab had minimal PMPM budget impact, ranging from -$0.0256 to -$0.0108. With the lowest 3-year total cost per treated patient among the newer therapies, glofitamab being an available option in the 3L + DLBCL market is estimated to save a hypothetical 1,000,000-member health plan $728,697 in cumulative total costs and $0.0202 in PMPM costs over 3 years."

HEOR • Journal • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

EPCORE Peds-1: Study of the Adverse Events and Change in Disease State of Pediatric Participants (and Young Adults Between the Ages of 18-25) With Relapsed/Refractory Aggressive Mature B-cell Neoplasms Receiving Subcutaneous (SC) Injections of Epcoritamab (clinicaltrials.gov) - P1 | N=17 | Active, not recruiting | Sponsor: Genmab | Recruiting ➔ Active, not recruiting

Adverse events • Enrollment closed • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pediatrics • CD20

Epcoritamab Plus Standard of Care Platinum-Based Chemotherapy and Autologous Hematopoietic Cell Transplant for the Treatment of Relapsed or Refractory Large B-cell Lymphoma (clinicaltrials.gov) - P2 | N=25 | Not yet recruiting | Sponsor: University of California, Davis

New P2 trial • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Large B Cell Lymphoma • Lymphoma • Marginal Zone Lymphoma • Nodal Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • BCL2

Utility of CSF IL-6 monitoring in managing ICANS associated with Epcoritamab treatment: a case report and literature review. (PubMed, J Clin Exp Hematop) - "These findings are consistent with similar reports from patients treated with CAR-T cells, suggesting that CSF IL-6 may serve as a reliable marker for ICANS progression. Further research that systematically measures CSF IL-6 in diverse clinical contexts could help validate its role as a biomarker, enhancing diagnostic precision and guiding optimal management strategies for ICANS."

IO biomarker • Journal • Review • B Cell Lymphoma • CNS Disorders • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • IL6

Optimal Use of Bispecific Antibodies for the Treatment of Diffuse Large B-Cell Lymphoma in Canada. (PubMed, Curr Oncol) - "Case discussions in this paper illustrate the potential real-world application of BsAbs, highlighting their role in treating patients who have relapsed after or are unable to undergo CAR-T cell therapy. Overall, glofitamab and epcoritamab represent valuable treatment options in the evolving landscape of R/R DLBCL."

Journal • Review • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • 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

Histological confirmation and radiotherapy facilitate continuation of epcoritamab in a patient with tumor flare reaction. (PubMed, Int J Hematol) - "Prompt biopsy upon detection of tumor enlargement led to an accurate diagnosis of TFR and informed therapeutic strategies. Subsequent radiotherapy (RT) effectively controlled local lesions while preserving the systemic immune response, suggesting that RT may be an option to prevent the recurrence and progression of TFR and help to avoid discontinuation of effective therapy."

Journal • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Six recommendations, one recommendation and a protocol [Google translation] (Danish Medicines Council) - "The Danish Medicines Council recommends lisocabtagene maraleucel (liso-cel) for the treatment of adult patients with the cancer types relapsed or refractory (R/R) diffuse large B-cell lymphoma, high-grade lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B, who experience relapse within 12 months of completing or are refractory to first-line chemo-immunotherapy...The recommendation applies to patients in good general condition (performance status 0 and 1)....The Danish Medicines Council does not recommend epcoritamab as monotherapy for the treatment of adult cancer patients with refractory/relapsed diffuse large B-cell lymphoma (DLBCL) after two or more systemic treatments...The Danish Medicines Council does not recommend amivantamab in combination with carboplatin and pemetrexed for first-line treatment of adult patients with advanced non-small cell lung cancer with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations."

Reimbursement • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Lymphoma • Non Small Cell Lung Cancer • Primary Mediastinal Large B-Cell Lymphoma

Government of Canada signs bilateral agreement with Nova Scotia to improve access to drugs for rare diseases (Yahoo Finance) - "The first step in this bilateral agreement will be to deliver funding to support the province for the following...drugs under the National Strategy for Drugs for Rare Diseases: Poteligeo, for the treatment of mycosis fungoides or Sézary syndrome...Epkinly for relapsed or refractory diffuse large B-cell lymphoma; Welireg for the treatment of treatment of von Hippel-Lindau (VHL) disease; Yescarta for the treatment of follicular lymphoma, large B-cell lymphoma (LBCL), diffuse large B-cell lymphoma (DLBCL), and high-grade B-cell lymphoma (HGBL); and, Koselugo, for the treatment of neurofibromatosis type 1."

Reimbursement • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Neurofibromatosis • Sezary Syndrome • Von Hippel-Lindau Syndrome