Epkinly (epcoritamab-bysp)
/ Genmab, AbbVie
- LARVOL DELTA
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January 12, 2025
Epcoritamab plus GemOx in transplant-ineligible relapsed/refractory DLBCL: results from the EPCORE NHL-2 trial.
(PubMed, Blood)
- P1/2 | "Gemcitabine + oxaliplatin (GemOx) with rituximab, a standard salvage therapy, yields complete response (CR) rates of approximately 30% and median overall survival (OS) of 10-13 months. Epcoritamab + GemOx yielded deep, durable responses and favorable long-term outcomes in ASCT‑ineligible R/R DLBCL. NCT04663347."
Journal • B Cell Lymphoma • Bone Marrow Transplantation • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation
March 05, 2026
Epcoritamab plus rituximab, dexamethasone, cytarabine, oxaliplatin/carboplatin induces deep and durable responses in transplant-eligible patients with relapsed or refractory diffuse large B-cell lymphoma: results from the EPCORE NHL-2 trial.
(PubMed, Haematologica)
- P1/2 | "Over half of patients proceeded to ASCT, a potentially curative treatment. These findings suggest the potential of epcoritamab combined with standard chemoimmunotherapy as an effective salvage treatment for patients with R/R DLBCL."
Journal • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Thrombocytopenia • Transplantation
September 08, 2026
Safety of Bispecific Antibodies in Patients With Autoimmune Disease and Hematologic Malignancies: A Real-World Propensity-Matched Study
(ACR Convergence 2026)
- "Adults with hematologic malignancies receiving BsAb therapy (teclistamab, elranatamab, blinatumomab, mosunetuzumab, glofitamab, or epcoritamab) were identified...Propensity score matching (1:1) balanced demographics, malignancy type, comorbidities, and prior glucocorticoid, methotrexate, rituximab, and antirheumatic exposures... Pre-existing autoimmune disease was associated with increased infectious complications, opportunistic infections, and critical illness within 90 days of BsAb therapy. Opportunistic infections persisted through 180 days. These findings highlight the need for infectious surveillance and prophylaxis as BsAbs enter rheumatologic practice."
Bispecific • Clinical • Real-world • Real-world evidence • Ankylosing Spondylitis • Autoimmune Hepatitis • Axial Spondyloarthritis • CNS Disorders • Hematological Malignancies • Hepatology • Immunology • Infectious Disease • Inflammatory Arthritis • Multiple Sclerosis • Myasthenia Gravis • Oncology • Psoriatic Arthritis • Rheumatoid Arthritis • Scleroderma • Septic Shock • Seronegative Spondyloarthropathies • Sjogren's Syndrome • Systemic Sclerosis • Vasculitis
October 02, 2026
FDA Approval Summary: Epcoritamab with Lenalidomide and Rituximab for Relapsed or Refractory Follicular Lymphoma.
(PubMed, Clin Cancer Res)
- "ORR per IRC was significantly higher in the epcoritamab plus R2 arm, based on prespecified analysis of the first 232 patients assessed (96% vs. 81% with R2;p<0.0001). This article summarizes key aspects of the regulatory review, including endpoint selection, randomized dose optimization, and a potential single-trial approach to support both accelerated and subsequent traditional approval."
FDA event • Journal • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology
October 01, 2026
Retained epcoritamab activity despite routine CD20 assay negativity approximately one terminal half-life after mosunetuzumab in B-cell lymphoma.
(PubMed, J Clin Exp Hematop)
- "During step-up dosing, grade 1 cytokine release syndrome resolved after one dose of tocilizumab. These findings suggest that negative CD20 results by routine assays shortly after mosunetuzumab therapy do not necessarily reflect true target loss. Integrated interpretation of histopathology, flow cytometry, and clonality studies may help guide subsequent CD20-directed treatment decisions."
Journal • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20 • CD79A • IL2 • PAX5
August 06, 2026
A case of generalised dermal hypersensitivity reaction secondary to Epcoritamab
(EADV 2026)
- "She received 6 cycles of Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisolone (R-CHOP) chemoimmunotherapy and 2 cycles of high dose Methotrexate for CNS prophylaxis...She further received 2 cycles of Rituximab, Gemcitabine, Dexamethasone and Cisplatin (RGDP) before being commenced on third line treatment with Epcoritamab injections. Her other regular medications include fexofenadine and as required paracetamol. She takes prophylactic cotrimoxazole and aciclovir but these were started years ago with the initial chemoimmunotherapy treatments for DLBCL...A weaning course of oral prednisolone at 0.5mg/kg/day dose was commenced alongside betamethasone valerate 0.1% ointment and hydrocortisone 1% ointment for her periorbital rash...Little data is available if cutaneous toxicity secondary to Epcoritamab is dose dependent or if its elimination half-life may help predict best treatment regime with the least cutaneous toxicity. This case report increases..."
Clinical • Atopic Dermatitis • B Cell Lymphoma • Cutaneous Lupus Erythematosus • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Lymphoma • Musculoskeletal Diseases • Musculoskeletal Pain • Neutropenia • Non-Hodgkin’s Lymphoma • Pneumonia • Respiratory Diseases • CD20
August 06, 2026
Diffuse Large B-Cell Lymphoma with Early Extranodal Relapse and Cutaneous Involvement
(EADV 2026)
- "Given the diagnosis of early relapse (within six months after ASCT), extranodal involvement, and high tumor burden, treatment with epcoritamab, a CD3×CD20 bispecific antibody, was initiated...Conclusion Secondary cutaneous involvement may be a manifestation of early extranodal relapse in DLBCL and indicates highly aggressive disease with poor prognosis. This case illustrates that early biopsy of suspicious skin lesions is essential for timely diagnosis."
Angiosarcoma • B Cell Lymphoma • Bone Marrow Transplantation • Diffuse Large B Cell Lymphoma • Gastrointestinal Disorder • Hematological Malignancies • Hepatology • Kaposi Sarcoma • Lymphoma • Non-Hodgkin’s Lymphoma • Respiratory Diseases • Sarcoma • Solid Tumor • BCL2 • BCL6 • IRF4 • MME
September 25, 2026
Risk factors for CRS and ICANS with Bispecific Antibodies for Aggressive Lymphomas.
(PubMed, Blood Adv)
- "CRS occurred in 31% (Grade 3+: 5%) and ICANS in 8% (Grade 3+: 2%) of patients, with no significant differences across glofitamab, mosunetuzumab, or epcoritamab. All patients with Grade 3+ CRS had very high serum C-Reactive Protein (sCRP, ≥15 mg/L) and elevated ferritin (>336 ng/mL) when available. These findings identify candidate laboratory thresholds and treatment related factors that warrant prospection validation for risk stratification and outpatient BsAb administration."
Journal • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CRP
September 01, 2026
Complete Metabolic Response to Pirtobrutinib in Refractory Richter Transformation
(SOHO 2026)
- "Venetoclax and obinutuzumab (VO) therapy was initiated...Acalabrutinib was stopped, and zanubrutinib was started 2 months later...He is now being started on epcoritamab as a bridge to ASCT... This case highlights the very uncommon finding of RT presenting as isolated splenomegaly. SF3B1 mutations have not been well characterized in RT; this case could contribute to the evolving understanding of the mutational landscape of RT. It was impressive to see a complete response (CR) with pirtobrutinib in RT in a patient refractory to chemoimmunotherapy, although only 13% achieved CR in the BRUIN study."
IO biomarker • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Richter's Syndrome • ATM • SF3B1
July 15, 2026
GASTROINTESTINAL AND HEPATOBILIARY TOXICITY OF BISPECIFIC T-CELL ENGAGING ANTIBODIES: A COMPARATIVE DISPROPORTIONALITY ANALYSIS OF THE FAERS DATABASE
(UEGW 2026)
- "Since 2022, the FDA has approved five agents across three target classes: teclistamab (BCMA); mosunetuzumab, glofitamab, and epcoritamab (CD20); and talquetamab (GPRC5D). Bispecific TCEs demonstrate distinct, target-specific GI and hepatobiliary safety profiles, with several high-magnitude and predominantly unlabeled signals. CD20-directed agents were enriched for hepatotoxicity and perforation-related events, while GPRC5D-targeting therapy showed a concentrated oral toxicity profile. These hypothesis-generating findings support targeted clinical vigilance and prospective studies to define absolute risks."
Bispecific • Gastrointestinal Disorder • Hematological Malignancies • Hepatology • Immunology • Liver Failure • Xerostomia • GPRC5D
September 01, 2026
Antigen Escape in Relapsed/Refractory Large B-Cell Lymphoma: A Case Series of CD20 Expression Loss After CD20-Directed Therapy
(SOHO 2026)
- "Context: CD20-directed therapy remains foundational in the management of LBCL, yet relapsed disease may emerge with loss of CD20 expression, limiting the utility of rituximab- or obinutuzumab-based regimens or bispecific antibodies...All patients had received prior CD20-directed therapy, most commonly rituximab-containing regimens, including R-CHOP, REPOCH, R-GemOx, R-ICE, rituximab-lenalidomide, or bendamustine-rituximab. Several also received contemporary salvage approaches, including polatuzumab-based therapy, epcoritamab, tafasitamab-lenalidomide, radiation, lymphodepleting chemotherapy, and CAR-T therapy with axicabtagene ciloleucel or tisagenlecleucel... CD20-negative conversion is a clinically consequential pattern of relapse in heavily pretreated LBCL. This series highlights the importance of repeat biopsy at progression to reassess targetable antigen expression and avoid ineffective recycling of CD20-directed therapy. Antigen reassessment should inform..."
Clinical • IO biomarker • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Indolent Lymphoma • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19 • CD20 • CD22
September 26, 2026
Epco, Zanu, Ritux for R/R FL or MZL
(clinicaltrials.gov)
- P2 | N=71 | Recruiting | Sponsor: Reid Merryman, MD | N=45 ➔ 71 | Trial completion date: Mar 2030 ➔ Mar 2032 | Trial primary completion date: Mar 2028 ➔ Mar 2030
Enrollment change • Trial completion date • Trial primary completion date • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology
May 28, 2026
Prognostic Significance of Baseline Metabolic Tumor Volume in Relapsed/Refractory Aggressive B-cell Lymphoma Patients Treated with Bispecific Antibodies: A Multi-Institution Discovery-Validation Study
(ASTRO 2026)
- "Materials/ We retrospectively analyzed 169 R/R aggressive B-cell lymphoma patients treated with BsAbs (epcoritamab n = 86, glofitamab n = 43, mosunetuzumab+polatuzumab n = 40) across two academic institutions. Baseline MTV is an independently validated predictor of PFS and OS in R/R aggressive B-cell lymphoma patients treated with BsAbs. An MTV threshold of 111 cc robustly stratifies outcomes across institutions and agents. Tumor burden may inform pre-treatment risk assessment to guide patient selection for BsAb therapy."
Bispecific • Clinical • IO biomarker • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology
August 29, 2026
Multifocal Gastrointestinal Cytomegalovirus Infection Mimicking Lymphoma Progression on PET/CT
(ACG 2026)
- "Case Description/ A 71-year-old man with relapsed stage IV follicular lymphoma on epcoritamab underwent surveillance positron emission tomography/computed tomography (PET/CT), which showed new fluorodeoxyglucose (FDG)-avid lesions at the gastroesophageal junction, gastroduodenal region, and cecum...Figure: Distal esophageal ulcerated lesion. Figure: Ileocecal valve mass-like lesion with exudate (left and right views)."
Cytomegalovirus Infection • Follicular Lymphoma • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Infectious Disease • Lymphoma
November 04, 2025
primary Phase 3 results from the epcore FL-1 trial of epcoritamab with rituximab and lenalidomide (R2) versus R2 for relapsed or refractory follicular lymphoma
(ASH 2025)
- P3 | "Epcor is the first CD20xCD3 bispecific antibody to demonstrate clinical benefit overstandard of care in a randomized phase 3 trial in patients with FL, with statistically significantimprovements in ORR, CR rate, and a 79% reduction in the risk of progression or death. Higher rates ofG3/4 neutropenia and infections were observed in E+R2, but these were manageable and none werefatal. CRS was low grade and the timing was predictable."
P3 data • Febrile Neutropenia • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Neutropenia
August 28, 2026
Epcoritamab with rituximab and lenalidomide as first-line treatment for follicular lymphoma (EPCORE NHL-2): an open-label, multicentre, phase 1/2 b trial.
(PubMed, Lancet Haematol)
- P1/2 | "Epcoritamab plus rituximab-lenalidomide showed high activity in first-line treatment for follicular lymphoma, with 95% of patients having a response over 3 years of follow-up, supporting this treatment regimen as a promising approach that warrants further analysis to ascertain its role in this setting."
Journal • P1/2 data • Atrial Fibrillation • Cardiovascular • CNS Disorders • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Novel Coronavirus Disease • Oncology • Ovarian Cancer • Pneumonia • Pulmonary Embolism • Rare Diseases • Respiratory Diseases • Septic Shock • Solid Tumor
September 24, 2026
EPKINLY receives Health Canada Approval for Adults with Follicular Lymphoma
(PRNewswire)
- "The authorization is supported by results from the Phase 3 EPCORE FL-1 study, which included 488 adults with relapsed or refractory follicular lymphoma who had received at least one prior line of systemic therapy."
Canada approval • Follicular Lymphoma
June 02, 2026
Phase 3 Results From the EPCORE FL-1 Trial of Epcoritamab (E) With Lenalidomide and Rituximab (R2) Versus R2 for Relapsed or Refractory Follicular Lymphoma (R/R FL)
(SOHO 2026)
- P3 | "E+R2 demonstrated superiority over R2 in R/R FL, with significantly improved ORR, CRR, and PFS. G3/4 neutropenia and infections were higher with E+R2 but manageable and not fatal. CRS was low-grade with predictable timing."
P3 data • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology
December 11, 2025
Epcoritamab, lenalidomide, and rituximab versus lenalidomide and rituximab for relapsed or refractory follicular lymphoma (EPCORE FL-1): a global, open-label, randomised, phase 3 trial.
(PubMed, Lancet)
- P3 | "Epcoritamab plus R2 resulted in significantly higher response rate and longer progression-free survival versus R2 among participants with follicular lymphoma who had received at least one line of therapy. Epcoritamab plus R2 had more grade 3 or higher adverse events versus R2. Adverse events were manageable and consistent with the established safety profiles of the individual components, with no new safety findings identified. These findings position epcoritamab plus R2 as a new standard of care for second-line or subsequent treatment of follicular lymphoma."
Journal • P3 data • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology
November 04, 2025
Epcoritamab + GemOx achieves durable >2-year remissions in relapsed/refractory (R/R) 2L+ diffuse large B-cell lymphoma (DLBCL): Long-term data reinforce clinical potential of the regimen across a diverse patient population
(ASH 2025)
- P1/2 | "In R/RDLBCL, standard salvage therapy with gemcitabine plus oxaliplatin (GemOx) yielded a complete response(CR) rate of 25%, overall response rate (ORR) of 41%, median progression-free survival (mPFS) of 3.6 mo,and median overall survival (mOS) of 12.9 mo (Abramson JS, et al. Epcor + GemOx demonstrated sustained remissions of >2 y, prolonged PFS and OS, anddeep MRD negativity in challenging-to-treat 2L+ R/R DLBCL; these results are widely applicable to adiverse pt population across the US and Europe. With longer follow-up, the safety profile remainedconsistent with previous reports. These findings support the combinability of epcor with standard-of-carechemotherapy and offer an effective option for ASCT-ineligible pts, a population with otherwise limited txchoices."
Clinical • B Cell Lymphoma • CNS Disorders • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Infectious Disease • Lymphoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Pancreatic Adenocarcinoma • Pancreatic Cancer • Respiratory Diseases
November 04, 2025
Fixed-duration epcoritamab monotherapy induces high response and MRD-negativity rates in elderly patients with newly diagnosed large B-cell lymphoma (LBCL) and comorbidities: Results from EPCORE DLBCL-3
(ASH 2025)
- P1/2, P2 | "Introduction: A proportion of newly diagnosed (1L) patients (pts) with LBCL are ineligible for standardcurative chemotherapy with full-dose R-CHOP due to age or comorbidities...EPCORE® DLBCL-3 (NCT05660967) is a 2-stage, phase 2 trial evaluating fixed-durationepcoritamab (epcor), a CD3×CD20 bispecific antibody, as monotherapy or combined with lenalidomide inelderly pts with 1L LBCL and comorbidities... Fixed-duration epcor monotherapy demonstrated robust efficacy (ORR, 70%), with early,deep, and durable responses in elderly pts with 1L LBCL and comorbidities, a population with significantunmet need and poor outcomes. Safety was manageable and consistent with previous reports of epcormonotherapy in this population. Epcor is a promising single-agent, chemotherapy-free tx for pts who arenot candidates for anthracycline-based chemotherapy."
Clinical • Minimal residual disease • Monotherapy • B Cell Lymphoma • Cardiovascular • CNS Disorders • Diabetes • Diffuse Large B Cell Lymphoma • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Mental Retardation • Metabolic Disorders • Neutropenia • Non-Hodgkin’s Lymphoma • Pneumonia • Renal Disease • Respiratory Diseases
September 01, 2026
Anchored Matching-Adjusted Indirect Comparison of Epcoritamab, Lenalidomide, and Rituximab vs Tafasitamab, Lenalidomide, and Rituximab in Relapsed/Refractory Follicular Lymphoma: EPCORE FL-1 vs inMIND
(SOHO 2026)
- P3 | "These findings show that epcoritamab+R2 is associated with significantly higher ORR and CR and improved PFS and TTNT vs tafasitamab +R2 positioning epcoritamab+R2 as the new chemotherapy-free standard of care in R/R FL. CD: cluster of differentiation. This abstract has been accepted for presentation at the Annual Congress of the European Hematology Association, June 11–14, 2026, Stockholm, Sweden."
Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology
August 29, 2026
Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
(clinicaltrials.gov)
- P2 | N=43 | Recruiting | Sponsor: City of Hope Medical Center | Initiation date: Apr 2026 ➔ Jul 2026
Trial initiation date • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Indolent Lymphoma • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma • Transplantation
April 25, 2024
Epcoritamab with rituximab + lenalidomide (R 2 ) in previously untreated (1L) follicular lymphoma (FL) and epcoritamab maintenance in FL: EPCORE NHL‑2 arms 6 and 7.
(ASCO 2024)
- P1/2 | "In arm 6, epcoritamab + R 2 continued to show deep, durable responses in 1L FL; safety was manageable and consistent with prior reports. In arm 7, the first epcoritamab maintenance data in FL showed conversions from PR to CR, with manageable safety and no new safety signals. The data warrant further evaluation of epcoritamab-based, chemotherapy-free regimens in FL."
Clinical • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Novel Coronavirus Disease • Oncology • Pneumonia • Respiratory Diseases • Septic Shock
June 19, 2024
Epcoritamab monotherapy in patients with relapsed or refractory follicular lymphoma (EPCORE NHL-1): a phase 2 cohort of a single-arm, multicentre study.
(PubMed, Lancet Haematol)
- P1/2 | "Epcoritamab monotherapy showed clinically meaningful activity in patients with multiply relapsed or refractory follicular lymphoma, and had a manageable safety profile."
Journal • Monotherapy • P2 data • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology
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