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

Indirect comparison of epcoritamab vs chemoimmunotherapy, mosunetuzumab, or odronextamab in follicular lymphoma. (PubMed, Blood Adv) - P1/2, P2 | "Epcoritamab also exhibited clinically relevant, numerically higher ORRs and demonstrated improved safety for CRS (grade ≥3) and ICANS vs mosunetuzumab or odronextamab. NCT03625037; NCT02500407; NCT03888105."

Journal • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

CD20×CD3 Bispecific Antibodies in B-NHL: A Review of Translational Science, Pharmacokinetics, Pharmacodynamics, and Dose Strategy in Clinical Research. (PubMed, Clin Transl Sci) - "Pivotal studies of four CD20 × CD3 bsAbs, mosunetuzumab, glofitamab, epcoritamab, and odronextamab, as monotherapy, have demonstrated robust responses with generally manageable safety profiles in patients with relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma after ≥ 2 lines of systemic therapy. This review provides a comprehensive overview of the clinical development of these four CD20 × CD3 bsAbs that have been investigated for the treatment of B-NHL, with a specific focus on translational assessments to select starting doses in first-in-human studies, management of CRS, application of modeling and simulation approaches to aid dose escalation and optimization/selection, and strategies used in the design of phase I-III clinical trials. By highlighting learnings and experiences from these four bsAbs assessed, which have not been summarized collectively elsewhere, we aim to promote more efficient study design for novel bsAbs in B-NHL..."

Journal • PK/PD data • Review • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

EPCORE NHL-5: A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1/2 | N=565 | Recruiting | Sponsor: Genmab | Phase classification: P2 ➔ P1/2

Adverse events • Phase classification • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6 • CCND1 • CD20

Infectious complications of CD20 x CD3 bispecific antibody therapy in patients with B-cell lymphoma. (ASCO 2025) - "Patients were treated with mosunetuzumab (n = 12), glofitamab (n = 10), and epcoritamab (n = 5). Most common antimicrobial prophylaxes were acyclovir (100%), SMX/TMP (89%), and fluconazole (42%)... CD20xCD3 therapy was associated with high rates of severe or fatal infection in this single-institution real world study. Greater consideration to preemptive IVIG and antimicrobial prophylaxis may be warranted with such therapy, and further studies to characterize individual risk and optimal management strategies are needed."

Clinical • B Cell Lymphoma • Candidiasis • Diffuse Large B Cell Lymphoma • Dyslipidemia • Febrile Neutropenia • Follicular Lymphoma • Hematological Malignancies • Hypertension • Infectious Disease • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Metabolic Disorders • Non-Hodgkin’s Lymphoma • Oncology • CD20

Exploring steroid prophylaxis to mitigate CRS: Enhancing access to bispecific antibodies in RRMM. (ASCO 2025) - "Prophylactic tocilizumab (toci) reduces CRS rates, but its cost and availability restrict broad use. BsAbs like epcoritamab use post-SUD steroid prophylaxis to mitigate CRS. This study evaluates the role of prophylactic (CRSppx) steroids—dexamethasone (dex) administered between SUDs—in reducing CRS in patients (pts) receiving talquetamab (Tal)... Prophylactic steroids reduced CRS incidence while maintaining high response rates and low infection and readmission rates. This approach could facilitate safe outpatient bsAb administration, improving accessibility in resource-limited settings. Further research is needed to validate these findings, assess steroid-related side effects, and refine dosing."

Infectious Disease • Leukemia • Lung Cancer • Melanoma • Multiple Myeloma • Plasma Cell Leukemia • Solid Tumor

First data from phase 1b/2 EPCORE NHL-4: Epcoritamab (Epcor) in Chinese patients (Pts) with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). (ASCO 2025) - P1/2 | "Epcor monotherapy showed favorable outcomes in Chinese pts with refractory and heavily pretreated R/R DLBCL. High ORR and CRR were achieved early and safety was manageable. CRS was low grade with predictable timing."

Clinical • P1/2 data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Thrombocytopenia

Comparative effectiveness of CAR-T cell therapy and BiTE therapy in relapsed/refractory diffuse large B-cell lymphoma: A propensity score matching analysis using real-world data from the US collaborative network database. (ASCO 2025) - "The CAR-T cell therapy included axicabtagene, lisocabtagene, tisagenlecleucel) or BiTE therapy included Epcoritamab and Glofitamab. This study provides valuable real-world insights into the comparative effectiveness of CAR-T cell therapy and BiTE therapy for relapsed/refractory DLBCL. The results, derived from propensity score-matched cohorts, offer far-reaching help to guide the holistic management of this patient population."

CAR T-Cell Therapy • Clinical • HEOR • Real-world • Real-world evidence • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Fatigue • Hematological Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Real world safety outcomes of an outpatient lymphoma bispecific antibody program: A single center experience from Johns Hopkins. (ASCO 2025) - " In this retrospective electronic medical record (EMR) analysis of 28 patients at the JHSKCCC IPOP treated with the CD20/CD3 BsA therapies epcoritimab or mosunetuzumab from 1/2023 to 11/2024, safety outcomes including CRS and ICANS incidence and management are analyzed...A total of 22 patients were treated with epcoritamab, of whom 6 developed grade 1 CRS, 6 developed grade 2 CRS, and 1 developed grade 4 CRS (vs. acute respiratory distress syndrome [ARDS] )...In patients who developed grade 2 CRS: 1 received tocilizumab alone, 2 received tocilizumab plus dexamethasone, 1 received dexamethasone alone, and 2 were treated at outside hospitals with limited records. Review of IPOP patient safety data resulted in the following initiatives targeting common sites of workflow breakdown: 1) Standardized BsAb toxicity management algorithms, 2) A BsAb toxicity management order set in the EMR including a PRN Tocilizumab dose, and 3) patient education resources for toxicity..."

Clinical • Real-world • Real-world evidence • Acute Respiratory Distress Syndrome • Hematological Malignancies • Infectious Disease • Lymphoma • Oncology • Respiratory Diseases • CD20

Comparative analysis of adverse event profiles for CAR-T cell therapies and bispecific antibodies in lymphoma. (ASCO 2025) - " A retrospective analysis was conducted using the FAERS database to assess AE reports associated with CAR-T therapies (Breyanzi, Kymriah, Yescarta, and Tecartus) and BsAbs (Epcoritamab, Glofitamab, Odronextamab, Mosunetuzumab, and Plamotamab). This analysis highlights key differences in the safety profiles of CAR-T and BsAb therapies for lymphoma. CAR-T therapies were associated with a higher incidence of neurological and psychiatric AEs, while BsAbs demonstrated a greater risk of infections. These findings may offer valuable guidance for clinicians in therapy selection and underscore the importance of vigilant monitoring, particularly for neurological toxicities in CAR-T treatments and infection-related risks with BsAbs."

Adverse events • CAR T-Cell Therapy • CNS Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Mental Retardation • Musculoskeletal Diseases • Oncology • Psychiatry

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

Novel analysis of 3-y results from the pivotal EPCORE NHL-1 study: Outcomes in patients (pts) with relapsed/refractory large B-cell lymphoma (R/R LBCL) and complete response (CR) at 2 y with epcoritamab (epcor) monotherapy. (ASCO 2025) - P1/2 | "This novel subgroup analysis of pts with R/R LBCL in CR at 2 y after starting epcor highlights long-term disease remission, overall survival, and potential for cure with epcor in some pts. Long-term safety remained manageable. These results underscore the benefits of epcor in the 3L+ setting and may inform personalized tx strategies."

Clinical • Monotherapy • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Novel Coronavirus Disease • Oncology • Pneumonia • Respiratory Diseases

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

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

Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

Based on the review of the data on safety and efficacy, the benefit-risk balance of Tepkinly (epcoritamab) in the approved indication(s) remains unchanged” (European Medicines Agency) - Pharmacovigilance Risk Assessment Committee (PRAC) Minutes of meeting on 7 – 10 Apr 2025: "Nevertheless, the product information should be updated to add a warning regarding haemophagocytic lymphohistiocytosis (HLH). Therefore, the current terms of the marketing authorization(s) should be varied”

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

Epkinly: Launch for 2L+ DLBCL (based on EPCORE DLBCL-2 trial) in 2027 (Genmab A/S) - ASCO 2025: Launch for 2L DLBCL (based on EPCORE DLBCL-1 trial) in 2027; Launch for 2L DLBCL (based on EPCORE DLBCL-4 trial) in 2029; Launch for 1L follicular lymphoma (based on EPCORE FL-2 trial) in 2031; Launch for 2L+ follicular lymphoma (based on EPCORE FL-1 trial) in 2026

Launch • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Oncology

EPCORE NHL-3: Trial of the Safety and Efficacy of Epcoritamab in Japanese Subjects With Relapsed or Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (R/R B-NHL) (clinicaltrials.gov) - P1/2 | N=78 | Active, not recruiting | Sponsor: Genmab | Trial completion date: Sep 2025 ➔ Sep 2027 | Trial primary completion date: Sep 2025 ➔ Sep 2027

Trial completion date • Trial primary completion date • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Large B Cell Lymphoma • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma • Small Lymphocytic Lymphoma

Epcoritamab in Patients With Newly Diagnosed Marginal Zone Lymphoma (MZL) (clinicaltrials.gov) - P2 | N=25 | Not yet recruiting | Sponsor: Izidore Lossos, MD | Initiation date: May 2025 ➔ Aug 2025

Trial initiation date • Extranodal Marginal Zone Lymphoma • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Nodal Marginal Zone Lymphoma • Oncology • Splenic Marginal Zone Lymphoma

Epcoritamab-bysp Yields Long-Term Disease Remission in Patients with Relapsed, Refractory Large B-Cell Lymphoma (Pharmacy Times) - P1/2 | N=166 | EPCORE NHL-1 (NCT03625037) | Sponsor: Genmab | "In the 3-year follow-up, epcor led to lasting complete responses (CR), with a median CR duration of 36 months, median progression-free survival (PFS) of 37 months, and median overall survival (OS) not yet reached in patients who achieved a complete response. This report shares long-term results from a post-hoc analysis of patients who were still in complete response 2 years after starting treatment—referred to here as patients in CR at 2 years....At the median follow-up of 37 months (range: 32–46 months), about 41% of patients achieved a CR, of which 49% maintained their responses at 2 years, and all but one achieved a response by the second assessment at week 12. Further, approximately 96% of patients remained in CR at 3 years, and the longest ongoing CR at the time of analysis exceeded 43 months."

P1/2 data • Large B Cell Lymphoma

Efficacy and safety of epcoritamab in Japanese patients with relapsed or refractory diffuse large B-cell lymphoma: 3-year follow-up from the EPCORE NHL-3 trial. (PubMed, Int J Clin Oncol) - P1/2 | "With  > 3 years of follow-up, epcoritamab treatment has consistently shown durable responses and high rates of MRD negativity in Japanese patients with R/R DLBCL. Safety was similar to previous reports. These long-term remissions reaffirm encouraging outcomes with epcoritamab for this challenging-to-treat population."

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

Epcoritamab and Tazemetostat for the Treatment of Relapsed or Refractory Grade I-IIIa Follicular Lymphoma (clinicaltrials.gov) - P2 | N=33 | Recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Jun 2027 ➔ Jul 2028 | Trial primary completion date: Jun 2027 ➔ Jul 2028

Trial completion date • Trial primary completion date • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

SUSTAINED REMISSION IN RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA WITH EPCORITAMAB MONOTHERAPY: EPCORE NHL-1 3-Y RESULTS AND NOVEL SUBGROUP ANALYSES IN PATIENTS WITH COMPLETE RESPONSE AT 2 Y (EHA 2025) - P1/2 | "At the 3-y follow-up, epcoritamab demonstrated long-term disease remission and the potential for cure in some pts with 3L+ R/R LBCL. The long-term safety profile was consistent with the established safety profile of epcoritamab. Additional data to further characterize pts with R/R LBCL who had long-term remission with epcoritamab monotherapy will be presented."

Clinical • Monotherapy • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Fatigue • Hematological Malignancies • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Genmab to Highlight New Data Evaluating Late-Stage Oncology Portfolio at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (GlobeNewswire) - "The presentations will include the first disclosure of results from a Phase 1/2 trial evaluating rinatabart sesutecan (Rina-S), an investigational folate receptor-alpha (FRa)-targeted, TOPO1-inhibor antibody-drug conjugate (ADC), in patients with recurrent/advanced endometrial cancer. Additionally, results from an analysis of the Phase 1/2 EPCORE NHL-1 study of epcoritamab, a T-cell–engaging bispecific antibody administered subcutaneously, including long-term follow-up in adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who remain in complete response (CR) at 2 years, will be presented."

P1/2 data • Diffuse Large B Cell Lymphoma • Endometrial Cancer • Non-Hodgkin’s Lymphoma

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

Cost Opportunity of Polatuzumab Vedotin as First-Line Therapy for DLBCL on Subsequent Treatments - Brazilian Cost Analysis (ISPOR 2025) - "OBJECTIVES: To analyze the direct cost of treating Diffuse large B-cell lymphoma (DLBCL) with polatuzumab vedotin (Pola-R-CHP) as first line (1L) therapy, CAR T-cell as a second line (2L) treatment, or epcoritamab as a third line (3L) therapy. This study demonstrates the potential to treat and cure more patients in 1L with Pola-R-CHP and provide them with a higher likelihood of avoiding progression compared to other treatments. The progression disease rate in 1L with Pola-R-CHP, is 23.3% for DLBCL patients and 16.1% for high-risk patients (ABC diagnosis), compared to 54% with CAR T-cell therapy and 72.2% with epcoritamab. This information could help decision-makers in engaging in evidence-based and value-driven discussions for patients and healthcare systems, promoting greater efficiency and transparency in terms of budget impact and resource allocation."

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

Time Toxicity of Bispecific Antibody (BsAb) Options in Relapsed or Refractory (R/R) Follicular Lymphoma (FL): Fixed-Duration Mosunetuzumab Versus Treat to Progression Epcoritamab (ISPOR 2025) - "Overall, fixed-duration mosunetuzumab had fewer HC days and more home days than treat to progression epcoritamab. These data provide important considerations to ensure more patient-centered treatment choices can be made."

Follicular Lymphoma • Hematological Malignancies • Infectious Disease • Lymphoma • Novel Coronavirus Disease • Oncology