Epcoritamab
- Generic Name
- Epcoritamab
- Brand Names
- Epkinly, Tepkinly
- Drug Type
- Biotech
- CAS Number
- 2134641-34-0
- Unique Ingredient Identifier
- D6OMY2L0WA
- Background
Epcoritamab is an IgG1-bispecific antibody that simultaneously binds to CD3 on T-cells and CD20 on B-cells. Epcoritamab promotes the activation and expansion of T-cells and, by being able to bind to both CD20 and CD3, it leads to the T-cell–mediated killing of CD20+ malignant B cells. Diffuse large B-cell lymphoma (DLBCL) is an aggressive type of cancer commonly treated with several cycles of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone. Although this regimen is effective in up to 60% of patients, patients with relapsed or refractory DLBCL have poor outcomes. The use of epcoritamab in this group of patients has high response rates, durable complete responses and manageable adverse events with few discontinuations.
The use of epcoritamab may lead to cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome. It is administered subcutaneously and is currently being evaluated as a monotherapy and in combination for the treatment of a variety of hematologic malignancies. In May 2023, epcoritamab was approved by the FDA under accelerated approval for the treatment of relapsed or refractory DLBCL. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
- Indication
Epcoritamab is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
- Associated Conditions
- Refractory Diffuse Large B Cell Lymphoma (DLBCL), Relapsed Diffuse Large B-cell Lymphoma (DLBCL)
Genmab to Present Extensive Epcoritamab Clinical Data at 2025 European Hematology Association Congress
• Genmab will showcase 14 abstracts evaluating epcoritamab, their subcutaneously administered T-cell engaging bispecific antibody, across multiple lymphoma settings at the 2025 EHA Congress in Milan.
• Two oral presentations will highlight epcoritamab combination therapies in relapsed/refractory DLBCL and previously untreated DLBCL patients, demonstrating the drug's potential as a core therapy across B-cell malignancies.
• The data builds on Genmab's comprehensive development program for epcoritamab, which includes five ongoing Phase 3 trials evaluating the therapy across various treatment lines and patient populations.
Cancer Vaccines Emerge as Promising Frontier in Oncology with Multiple Approaches Showing Clinical Success
• Cancer vaccines are gaining momentum across multiple tumor types, with FDA-approved options like BCG, sipuleucel-T, and talimogene laherparepvec demonstrating clinical utility in bladder cancer, prostate cancer, and melanoma respectively.
• Novel vaccine approaches including mRNA-based mRNA-4157, KRAS-targeted ELI-002, and viral vector-based aglatimagene besadenovec are showing promising results in clinical trials, with significant improvements in survival outcomes across various cancers.
• Experts believe cancer vaccines hold particular promise in early-stage and high-risk disease settings by targeting micrometastatic disease, potentially increasing cure rates and transforming treatment paradigms when combined with existing immunotherapies.
Genmab Reports Strong Q1 2025 DARZALEX Sales of $3.24 Billion, Demonstrating Continued Market Dominance
• DARZALEX (daratumumab) generated $3.24 billion in global net sales during Q1 2025, with $1.83 billion from U.S. markets and $1.41 billion internationally.
• Genmab receives royalties on all worldwide sales of both intravenous DARZALEX and the subcutaneous formulation (DARZALEX FASPRO in the U.S.) through its licensing agreement with Johnson & Johnson.
• The strong Q1 performance supports analysts' projections of 15.1% annual revenue growth for Genmab over the next three years, despite the company's stock currently trading at a significant discount to target prices.
Canada Expands Access to Rare Disease Medications Through Provincial Agreements
• The Government of Canada has signed bilateral agreements with Yukon and Nova Scotia, investing over $8.5 million and $39 million respectively over three years to improve access to drugs for rare diseases.
• The agreements will provide funding for several specialized medications including Yescarta, a CAR T-cell therapy for B-cell lymphomas, and five additional drugs in Nova Scotia for conditions including mycosis fungoides and von Hippel-Lindau disease.
• These initiatives are part of Canada's National Strategy for Drugs for Rare Diseases, which aims to help the one in 12 Canadians living with rare diseases access treatments that can cost between $100,000 and $4 million annually.
Johnson & Johnson Declines Option for Genmab's HexaBody-CD38 Despite Promising Clinical Data
• Johnson & Johnson has decided not to exercise its option to license Genmab's HexaBody-CD38 antibody therapeutic, despite promising clinical efficacy data in multiple myeloma patients.
• Phase 2 trial results showed HexaBody-CD38 achieved a 55% overall response rate compared to 52% for daratumumab, with higher rates of very good partial response (29% vs 17%) and complete response (7% vs 2%).
• Following portfolio prioritization, Genmab will not pursue further clinical development of HexaBody-CD38, instead focusing on its late-stage pipeline including EPKINLY and two wholly owned Phase 3 assets.
Lunsumio Shows Durable 3-Year Remission in Follicular Lymphoma, Setting New Benchmark for Bispecific Antibodies
• Lunsumio demonstrated a 60% complete response rate and 77.8% objective response rate in relapsed/refractory follicular lymphoma patients over a 37.4-month follow-up period.
• The bispecific antibody therapy achieved an estimated 82.4% three-year overall survival rate with just eight cycles of fixed-duration treatment, maintaining durable remission in most complete responders.
• As Korea's first GIFT-approved drug, Lunsumio's long-term data could potentially break the reimbursement barrier for bispecific antibodies, offering advantages of outpatient administration and minimal pretreatment requirements.
Novel CAR T-Cell Therapy Shows 97% Response Rate in Advanced Multiple Myeloma Trial
• Phase II IMMagine-1 trial demonstrates anitocabtagene autoleucel achieves 97% overall response rate in heavily pretreated multiple myeloma patients, with 62% achieving complete response or better.
• The novel CAR T-cell therapy showed a favorable safety profile with mostly grade 1-2 cytokine release syndrome and 93% of evaluable patients achieving MRD negativity.
• Six-month progression-free survival reached 93.3%, with estimated 12-month overall survival at 96.5%, marking significant potential for treatment of relapsed/refractory multiple myeloma.
Incyte Reports Strong 2024 Growth with $4.2B Revenue, Outlines Ambitious 2025 Pipeline Milestones
• Incyte achieved total revenues of $4.2 billion in 2024, marking a 15% year-over-year growth, driven by strong performance of Jakafi ($2.8B) and Opzelura ($508M).
• The company anticipates four new product launches in 2025, including Niktimvo for chronic GVHD and expanded indications for existing therapies in atopic dermatitis and lymphoma.
• Incyte's R&D pipeline shows significant advancement with plans for four pivotal study readouts, three Phase 3 study initiations, and seven proof-of-concept study results expected in 2025.
Dual Targeting PD-L1 and 4-1BB Overcomes Lenalidomide Resistance in Follicular Lymphoma
• A phase 2 trial identified dendritic cells (DCs) as critical in follicular lymphoma (FL) progression under rituximab plus lenalidomide (R2) treatment, highlighting the need for new strategies.
• PU.1, a transcription factor, mediates lenalidomide resistance by modulating PD-L1 and 4-1BB interaction between lymphoma cells and DCs, impacting anti-tumor immunity.
• Dual targeting of PD-L1 and 4-1BB with a bispecific antibody counteracts PU.1-mediated alterations in DCs, enhancing lymphoma cell autophagy and anti-tumor activity in vitro and in vivo.
• The study suggests that combining immune checkpoint modulation with lenalidomide could be a promising chemo-free immunotherapy approach for overcoming resistance in FL treatment.
AbbVie's Telisotuzumab Vedotin Shows Promise in c-Met Overexpressing NSCLC
• AbbVie's telisotuzumab vedotin (Teliso-V) demonstrated a 35% overall response rate in patients with high c-Met expression in the LUMINOSITY trial.
• The FDA granted breakthrough therapy designation to Teliso-V, highlighting its potential to significantly improve outcomes in NSCLC patients.
• A phase 3 trial (TeliMET-NSCLC-01) is underway, comparing Teliso-V to docetaxel in c-Met-positive, non-squamous NSCLC patients.
• Teliso-V targets c-Met, a protein involved in cancer progression and resistance to therapies like EGFR inhibitors, offering a novel approach.
Travel Burden Analysis Reveals Higher Costs for Epcoritamab Treatment in Lymphoma Patients
• Real-world analysis shows patients receiving epcoritamab for DLBCL travel nearly twice the distance (4,486 miles) compared to glofitamab (2,243 miles) over 12 months of treatment.
• Study finds lymphoma patients travel an average of 80.1 miles each way for bispecific antibody therapy, with 24% traveling over 60 miles per treatment session.
• Researchers emphasize the importance of considering "time toxicity" and travel burden when making treatment decisions, particularly for patients with limited resources or transportation access.
FDA Approvals in 2024: Advancing Treatment Paradigms in Solid Tumors and Hematologic Malignancies
• The FDA granted over 65 approvals in 2024, significantly impacting treatment paradigms across various cancers, including breast, gynecologic, skin, and genitourinary malignancies.
• Several tumor-agnostic approvals, such as fam-trastuzumab deruxtecan-nxki (Enhertu) for HER2-positive solid tumors and repotrectinib (Augtyro) for NTRK fusion-positive tumors, marked advancements in precision medicine.
• Immunotherapies like nivolumab (Opdivo) and pembrolizumab (Keytruda) received multiple approvals, including combinations with chemotherapy for urothelial and endometrial carcinomas, improving patient outcomes.
• Targeted therapies like vorasidenib (Voranigo) for low-grade glioma and selpercatinib (Retevmo) for RET-mutated thyroid cancers addressed unmet needs and demonstrated high efficacy and tolerability.
Lisocabtagene Maraleucel Shows Promise in Relapsed/Refractory Lymphomas
• Lisocabtagene maraleucel (liso-cel) demonstrates efficacy and safety in second-line treatment of relapsed/refractory large B-cell lymphoma (LBCL), aligning with pivotal trial outcomes.
• The TRANSCEND FL trial indicates liso-cel achieved a significant overall response rate in relapsed/refractory marginal zone lymphoma (MZL), meeting the primary endpoint.
• Five-year data from TRANSCEND-NHL-001 underscore the curative potential of liso-cel in third-line LBCL, showing a 38% overall survival rate.
• Real-world data supports liso-cel's effectiveness across diverse LBCL patient subgroups, reinforcing its role as a standard-of-care treatment option.
Epcoritamab Combination Shows High Response Rates in Follicular Lymphoma
• Phase 1b/2 trial data shows a 96% overall response rate and 87% complete response rate in relapsed or refractory follicular lymphoma patients.
• The combination therapy of epcoritamab plus lenalidomide and rituximab demonstrates strong and durable efficacy with a two-year overall survival rate of 90%.
• The FDA granted breakthrough therapy designation to epcoritamab plus R2, supporting further Phase 3 trials for relapsed or refractory follicular lymphoma.
• Common treatment-emergent adverse events included neutropenia and cytokine release syndrome, with COVID-19 leading to treatment discontinuation in some patients.
FDA Accepts sBLA for Glofitamab Plus Chemotherapy in Relapsed/Refractory DLBCL
• The FDA has accepted Roche's sBLA for glofitamab combined with gemcitabine and oxaliplatin (GemOx) for relapsed/refractory DLBCL patients ineligible for autologous stem cell transplant.
• The sBLA is based on the phase 3 STARGLO trial, which demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to rituximab plus GemOx.
• The FDA is expected to make a decision on the approval of glofitamab in combination with GemOx by July 20, 2025, offering a potential new treatment option.
• The safety profile of glofitamab plus GemOx was consistent with the known safety profiles of the individual agents, with cytokine release syndrome being a common adverse event.
Triplet Therapies Show Promise in Treating Leukemias: ASH 2024 Highlights
• Novel triplet therapies are demonstrating significant positive results in treating relapsed/refractory and newly diagnosed leukemias, according to multiple clinical trials.
• A revumenib-based triplet achieved an 82% overall response rate in relapsed/refractory AML patients with KMT2A or NUP98 rearrangements, offering an improved treatment option.
• Ivosidenib, venetoclax, and azacitidine triplet showed a 94% overall response rate in IDH1-mutant hematologic malignancies, positioning it as a potential standard-of-care.
• Pirtobrutinib, obinutuzumab, and venetoclax triplet yielded high rates of undetectable measurable residual disease in previously untreated CLL patients.
FDA to Review Belantamab Mafodotin and Linvoseltamab Combinations for Multiple Myeloma
• The FDA has accepted a BLA for belantamab mafodotin combinations with bortezomib plus dexamethasone and pomalidomide plus dexamethasone for multiple myeloma treatment.
• Regeneron's linvoseltamab BLA resubmission has been accepted by the FDA, with a decision expected by July 10, 2025, for relapsed/refractory multiple myeloma.
• Clinical trials DREAMM-7 and DREAMM-8 support the belantamab mafodotin BLA, while LINKER-MM1 supports the linvoseltamab BLA, showcasing improved progression-free survival.
• Both belantamab mafodotin and linvoseltamab are under review by other regulatory authorities, potentially expanding treatment options for multiple myeloma patients.
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