RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Australia), Conditional marketing approval (European Union)

Structure/Sequence

Sequence Code 143818L

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Sequence Code 319323760L

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Sequence Code 319323796H

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Sequence Code 616714422H

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Clinical Trials associated with Epcoritamab

NCT06905509

/ Not yet recruitingPhase 2IIT

A Phase 2 Study of Epcoritamab (Epco) Plus Physician's Choice of Platinum-Containing Chemotherapy Pre-Autologous Hematopoietic Cell Transplantation (AutoHCT) Followed by Post-AutoHCT Epco Consolidation/ Maintenance in Relapsed/ Refractory Large B-Cell Lymphoma (R/R LBCL)

This phase II trial tests how well epcoritamab in combination with standard of care (SOC) platinum-based chemotherapy (rituximab, ifosfamide, carboplatin, etoposide [RICE], rituximab, cytarabine, dexamethasone, oxaliplatin or carboplatin RDHAP/X] or gemcitabine and oxaliplatin [Gem/Ox]) and autologous hematopoietic cell transplant (HCT) works in treating patients with large B-cell lymphoma (LBCL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Epcoritamab, a type of bispecific T-cell engager, binds to a protein called CD3, which is found on T cells (a type of white blood cell). It also binds to a protein called CD20, which is found on B cells (another type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells and some types of cancer cells. This may help the immune system kill cancer cells. Chemotherapy drugs, such as ifosfamide, etoposide phosphate, cytarabine, and gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. An autologous HCT is a procedure in which blood-forming stem cells (cells from which all blood cells develop) are removed, stored, and later given back to the same person. Giving epcoritamab in combination with SOC platinum-based chemotherapy, such as RICE, RDHAP/X and Gem/Ox, and autologous HCT may kill more cancer cells in patients with relapsed or refractory LBCL.

Start Date01 Aug 2025

Sponsor / Collaborator

University of California, Davis

[+1]

NCT06796998

/ Not yet recruitingPhase 2IIT

Phase 2 Trial of Epcoritamab in Patients With Newly Diagnosed Marginal Zone Lymphoma (MZL)

The purpose of this study is to assess if an investigational treatment of Epcoritamab will be beneficial for patients with Marginal Zone Lymphoma (MZL).

Start Date01 Aug 2025

Sponsor / Collaborator

University of Miami

[+2]

NCT06919939

/ Not yet recruitingPhase 2IIT

Phase 2 Study of Epcoritamab in Combination With Loncastuximab Tesirine in Relapsed/Refractory Large B-cell Lymphoma

The purpose of this study is to determine whether combining Loncastuximab Tesirine with Epcoritamab is tolerable and effective for reducing and/or eliminating lymphoma cells in the body.

Start Date01 Aug 2025

Sponsor / Collaborator

University of Miami

[+2]

100 Clinical Results associated with Epcoritamab

100 Translational Medicine associated with Epcoritamab

100 Patents (Medical) associated with Epcoritamab

Literatures (Medical) associated with Epcoritamab

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

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

Article

Author: Li, Jia ; Mahmoudjafari, Zahra ; Masaquel, Anthony ; Parisé, Hélène ; Bercaw, Eric ; Bognar, Katalin ; Wang, Si-Tien

BACKGROUND:

Glofitamab is a T-cell engaging bispecific monoclonal antibody that was granted accelerated approval from the United States Food and Drug Administration for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after ≥2 lines of systemic therapy (3L+).

METHODS:

A budget impact model was developed for a hypothetical blended commercial/Medicare health plan with 1,000,000 members. 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). Total costs included those for drugs, wastage, administration, grade ≥3 adverse reactions, and all-grade cytokine release syndrome) and routine care. Market shares were based on internal projections and expert opinions. Total and per-member per-month (PMPM) net budget impacts over 3 years were calculated.

RESULTS:

Approximately nine patients were projected to be eligible for 3L + DLBCL treatment in a health plan of 1,000,000 members. The introduction of glofitamab as a treatment option resulted in estimated total and PMPM cost savings of $728,697 and -$0.0202, respectively, over 3 years. Costs were reduced across all cost categories but particularly in drug costs. Among the newer therapies, total 3-year cost per treated patient was lowest for glofitamab: $226,658 versus Tisa-cel = $564,113; Axi-cel = $540,002; Liso-cel = $516,272; and Epcor = $335,293. Across all sensitivity analyses, the inclusion of glofitamab had minimal PMPM budget impact, ranging from -$0.0256 to -$0.0108.

CONCLUSIONS:

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.

03 Jul 2025·Expert Opinion On Drug Safety

Comprehensive analysis of adverse events associated with T-cell engagers using the FAERS database

Article

Author: Ma, Junlong ; Zhang, Yefu ; Le, Xiangyang

BACKGROUND:

T-cell engagers (TCEs) are transformative immunotherapies with significant potential in treating hematologic malignancies and solid tumors. However, their real-world safety profiles remain inadequately characterized.

RESEARCH DESIGN AND METHODS:

Using the FDA Adverse Event Reporting System (FAERS) database (October 2019 - September 2024, 8,747,158 reports), we analyzed adverse events (AEs) associated with nine TCEs. Disproportionality analysis identified overreported AEs, with 11,963 unique reports analyzed after deduplication.

RESULTS:

Blinatumomab was the most reported TCE (n = 4,950), and Tarlatamab the least (n = 185). Predominant AEs included immune system disorders, particularly cytokine release syndrome (IC₀₂₅ range: 6.08-7.47). Drug-specific signals included reproductive system and breast disorders (IC₀₂₅: 2.74) and vascular disorders (IC₀₂₅: 2.25) with Tebentafusp, renal and urinary disorders with Epcoritamab (IC₀₂₅: 1.84), and eye disorders with Elranatamab (IC₀₂₅: 1.81). Novel AEs were also uncovered, including second malignant neoplasms, vasogenic cerebral edema with Mosunetuzumab (IC₀₂₅: 5.77, ROR₀₂₅: 56.29), and hydronephrosis with Epcoritamab (IC₀₂₅: 7.50, ROR₀₂₅: 180.70). Early-onset events (0.5-9.5 days) were linked to four TCEs, while delayed-onset events (>20 days) were linked to five others.

CONCLUSIONS:

This study highlights diverse AE profiles of TCEs, providing insights for clinicians to optimize their safe use in practice.

01 Jul 2025·INTERNATIONAL JOURNAL OF HEMATOLOGY

Histological confirmation and radiotherapy facilitate continuation of epcoritamab in a patient with tumor flare reaction

Article

Author: Mihashi, Tatsuya ; Kai, Keita ; Kusaba, Kana ; Okamoto, Sho ; Yoshimura, Mariko ; Ando, Toshihiko ; Jinnouchi, Kazuki ; Sano, Haruhiko ; Kimura, Shinya ; Kidoguchi, Keisuke ; Katsuya, Hiroo ; Fujita, Mai ; Itamura, Hidekazu

Epcoritamab, a CD3 × CD20 bispecific antibody, has been approved as salvage therapy for patients with relapsed/refractory large B-cell lymphoma. However, immunotherapeutic agents have been linked to tumor flare reaction (TFR), which is characterized by rapid tumor proliferation associated with the immune response. This report describes the case of a 71-year-old man with relapsed/refractory diffuse large B-cell lymphoma who developed TFR in the cervical lymph nodes during treatment with epcoritamab. 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.

187

News (Medical) associated with Epcoritamab

23 Jun 2025

·www.fiercepharma.com

Roche's bispecific-ADC combo keeps cancer at bay in 2nd shot at 2nd-line large B-cell lymphoma

If approved, Lunsumio and Polivy could offer an off-the-shelf, chemo-free regimen for patients with second-line large B-cell lymphoma. Roche has demonstrated the power of combining two of oncology’s hottest modalities—bispecifics and antibody-drug conjugates (ADCs)—in a Lunsumio-Polivy regimen in large B-cell lymphoma (LBCL).The combination of the CD20xCD3 bispecific Lunsumio and the CD79b-directed ADC Polivy significantly reduced the risk of progression or death by 59% versus the traditional R-GemOx regimen in patients with previously treated LBCL who are not eligible for stem cell transplant. R-GemOx includes Roche’s own Rituxan and the chemotherapies gemcitabine and oxaliplatin.Patients in the Lunsumio-Polivy group went a median 11.5 months without disease progression versus 3.8 months for R-GemOx, according to the primary analysis of the phase 3 Sunmo study presented at the International Conference on Malignant Lymphoma.Roche said it will submit the trial results to global health authorities, including the FDA. While Lunsumio is currently approved as an intravenous infusion to treat follicular lymphoma, the Sunmo trial uses a subcutaneous formulation of the drug. Polivy, meanwhile, received the FDA’s approval as part of a combination for certain previously untreated patients with LBCL in 2023.The positive Sunmo readout could give Roche another shot at second-line LBCL after the regulatory prospects of its other CD20xCD3 bispecific, Columvi, were thrown into doubt in the U.S.In its own phase 3 study, Columvi, used in tandem with GemOx, led to a 63% reduction in the risk of disease worsening or death in patients with previously treated diffuse large B-cell lymphoma (DLBCL). The median progression-free survival was 12.1 months for Columvi-GemOx and 3.3 months for control. The Columvi regimen also significantly reduced the risk of death by 41% compared with R-GemOx at the primary analysis of the Starglo trial.Despite the positive readout, an FDA advisory committee agreed with an FDA internal analysis that the Starglo results are not applicable to a U.S. patient population. The Starglo study enrolled 48% of its total population in Asia but just 9% of patients in the U.S. In addition, an FDA subgroup analysis found a negative patient survival trend in participants from non-Asian countries.Given the bleak feedback, the Starglo regimen looks unlikely to be approved in the U.S., even though the European Commission has cleared it in second-line DLBCL. Overall survival data remained immature in the Sunmo trial of the Lunsumio-Polivy regimen. That metric currently numerically favored Lunsumio-Polivy, with a preliminary 20% death risk reduction. But there’s no breakdown of survival data by subgroups. The study is continuing toward its final overall survival analysis. A statistically significant overall survival showing is not required to win an approval in second-line LBCL in the U.S. The FDA has previously approved CAR-T therapies from Gilead Sciences and Bristol Myers Squibb in the disease setting based on the event-free survival endpoint.However, regional representation might become a sticking point for Roche with the FDA again. Sunmo enrolled 20—or about 10%—of its 208 patients in the U.S. and Canada. Latin America represents 41% of the study participation and East Asia 38%.But in a piece of good news for Roche, the progression-free survival analysis for the small North America cohort showed a massive 87% benefit in favor of Lunsumio-Polivy.Unlike Starglo, Sunmo also enrolled patients with high-grade B-cell lymphoma and follicular lymphoma grade 3b in addition to the 78% of individuals with DLBCL. Disease progression data favored Lunsumio-Polivy in each of the three subgroups, with DLBCL’s 62% the biggest among the three lymphoma types.The treatment effect looked similar for patients who received just one prior line of therapy versus at least two.In terms of toxicity, the rates of treatment-related grade 3 or 4 adverse events were similar, at 52.6% and 51.6%, for Lunsumio-Polivy and R-GemOx, respectively. And treatment-related deaths were recorded in 1.5% and 3.1% of patients in the groups, respectively.“If approved, this off-the-shelf treatment combination of [Lunsumio] and [Polivy] could be administered over a fixed period of time, without mandatory hospitalization or traditional chemotherapy, which could provide a meaningful option for patients with relapsed or refractory LBCL,” the Sunmo study’s lead author, Jason Westin, M.D., from the MD Anderson Cancer Center, said in a statement Friday. Between its two CD20xCD3 T-cell engagers, Roche angled Columvi toward the more aggressive DLBCL in its development plan. The Swiss pharma is also running the phase 3 Skyglo study, testing the combination of Columvi, Polivy and the R-CHP regimen in first-line DLBCL.Meanwhile, AbbVie and Genmab are running the phase 3 Epcore NHL-2 trial for its rival CD20xCD3 bispecific Epkinly in a combination with R-CHOP in newly diagnosed DLBCL.

Phase 3Clinical ResultDrug Approval

20 Jun 2025

·firstwordpharma.com

Roche's closes in on Epkinly with SC Lunsumio data in lymphoma

Roche's subcutaneous (SC) version of CD20xCD3 bispecific T-cell engager Lunsumio (mosunetuzumab) has shown it can keep large B-cell lymphoma (LBCL) at bay for longer than a widely used treatment regimen. Results from the Phase III SUNMO trial, unveiled Friday at the International Conference on Malignant Lymphoma (ICML), crank up the pressure on AbbVie and Genmab's rival Epkinly (epcoritamab).The SUNMO trial is evaluating SC Lunsumio together with Roche's anti-CD79b antibody-drug conjugate Polivy (polatuzumab vedotin), which is given intravenously, in 242 patients with relapsed or refractory LBCL who are ineligible for autologous stem cell transplant. The primary endpoints are progression-free survival (PFS) and overall response rate (ORR).30% higher ORRAfter a follow-up of nearly two years, the Lunsumio combination delivered median PFS of 11.5 months, versus 3.8 months for the control arm receiving rituximab, gemcitabine and oxaliplatin (R-GemOx) — translating to a 59% reduction in risk of disease progression or death. The ORR was also markedly higher at 70.3% versus 40%, with complete responses more than doubling (51.4% vs. 24.3%).The interim analysis showed a numerical edge for the experimental regimen when it comes to overall survival as well — 18.7 months versus 13.6 months — although the data aren't yet mature.Simpler treatment"If approved, this off-the-shelf treatment combination…could be administered over a fixed period of time, without mandatory hospitalisation or traditional chemotherapy, which could provide a meaningful option for patients," said Jason Westin, lead investigator on the SUNMO trial.Roche reported that the combination's safety profile was consistent with what's already known for the individual drugs. Cytokine release syndrome occurred in about a quarter of patients, though fewer than 5% experienced Grade 2 or 3 events, and there were no cases of immune effector cell-associated neurotoxicity syndrome (ICANS). The incidence of serious adverse events and fatalities was similar between the Lunsumio-Polivy and R-GemOx arms: Grade 3/4 events occurred in 58.5% versus 57.8% of patients, and Grade 5 events in 5.2% versus 6.3%, respectively. Fewer patients in the combination arm discontinued treatment due to side effects (2.2% vs. 4.7%).Catching up with EpkinlyLunsumio has had FDA approval since 2022 for intravenous use in follicular lymphoma (FL), but Roche hopes this new subcutaneous version will expand its reach. The company plans to submit the SUNMO results to regulators worldwide, including in the US. The injectable version first showed promise in a separate Phase II study presented last December, demonstrating pharmacokinetic equivalence to the intravenous formulation in third-line FL, along with a 76.6% overall response rate and a 61.7% rate of complete response.But Roche isn't alone in the space. AbbVie and Genmab's subcutaneous treatment Epkinly — another CD20xCD3 bispecific T-cell engager — was approved in 2023 for relapsed/refractory diffuse LBCL and added FL to its label last year.

Clinical ResultPhase 3Drug ApprovalPhase 2

18 Jun 2025

·www.globenewswire.com

Genmab Announces Epcoritamab Investigational Combination Therapy Demonstrates High Response Rates in Patients with Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) Eligible for Autologous Stem Cell Transplantation (ASCT)

June 15, 2025 Results from the EPCORE® NHL-2 trial show investigational treatment with epcoritamab in combination with rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) led to an overall response rate (ORR) of 87 percent and a complete response (CR) rate of 65 percent in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) Data further demonstrates the potential of epcoritamab in combination with salvage chemoimmunotherapy to increase the proportion of patients to qualify for Autologous Stem Cell Transplantation (ASCT) Data was presented during an oral session at the 30th European Hematology Association (EHA) Congress Genmab A/S (Nasdaq: GMAB) today announced new results from the Phase 1b/2 EPCORE® NHL-2 trial Arm 10 (NCT04663347), evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, in combination with rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in adult patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) who are eligible for autologous stem cell transplantation (ASCT). Results demonstrated an overall response rate (ORR) of 87 percent, a complete response (CR) rate of 65 percent and a partial response (PR) of 23 percent. The majority of patients (65 percent) proceeded to ASCT. At six months, an estimated 81 percent of responses were ongoing, 74 percent of patients were progression free, and 100 percent of patients were alive. These results were shared today during an oral presentation at the 30th European Hematology Association (EHA) 2025 Congress. The safety profile of this combination therapy showed cytokine release syndrome (CRS) being low grade and no discontinuations due to treatment-emergent adverse events (TEAEs). The most common TEAEs were neutropenia (74 percent), anemia (68 percent), and thrombocytopenia (68 percent). CRS occurred in 52 percent; all were low grade (1/2) and resolved. One patient had immune effector cell-associated neurotoxicity syndrome (ICANS; grade 1), which resolved. No clinical tumor lysis syndrome was observed. Infections occurred in 18 patients (58 percent); five (16 percent) had serious infections. There were no Grade 5 TEAEs. “These results are particularly encouraging because many of the patients in this study had high-risk disease, having progressed rapidly after initial treatment,” said Raul Cordoba, MD, PhD, Head of the Lymphoma Unit at the Fundacion Jimenez Diaz University Hospital, Madrid, Spain. “This combination therapy of epcoritamab plus rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) offers a potential new treatment option for patients with relapsed/refractory diffuse large B-cell lymphoma, providing high response rates and a bridge to potentially curative autologous stem cell transplantation." Among patients in the study who progressed within 12 months after first-line treatment (n=20), epcoritamab in combination with R-ICE demonstrated an 85 percent ORR and 55 percent CR. Patients in the study who progressed after 12 months from first-line therapy experienced a 91 percent ORR and 82 percent CR. Additionally, patients with one prior line of therapy experienced an 88 percent ORR and 68 percent CR, and patients who were treated with more than one prior line of therapy experienced an 83 percent ORR and 50 percent CR. “The results from this trial highlight the potential of this investigational epcoritamab containing regimen, especially in patients who progress quickly after initial treatment, and reinforce our joint efforts with AbbVie to develop epcoritamab as a core therapy for B-cell lymphomas, especially as we develop epcoritamab in earlier lines of therapy and a broader patient population,” said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. “Our comprehensive EPCORE clinical trial program is dedicated to advancing epcoritamab as both monotherapy and in combination to address the significant unmet need in relapsed/refractory diffuse large B-cell lymphoma and other hematologic malignancies." Use of epcoritamab + R-ICE in patients with R/R DLBCL eligible for ASCT is not approved and the safety and efficacy of epcoritamab for use as a combination therapy in DLBCL have not been established. DLBCL is the most common type of non-Hodgkin's lymphoma (NHL) worldwide, accounting for approximately 25-30 percent of all NHL cases. In the U.S., there are approximately 25,000 new cases of DLBCL diagnosed each year. DLBCL can arise in lymph nodes as well as in organs outside of the lymphatic system, occurs more commonly in the elderly and is slightly more prevalent in men. DLBCL is a fast-growing type of NHL, a cancer that develops in the lymphatic system and affects B-cell lymphocytes, a type of white blood cell. For many people living with DLBCL, their cancer either relapses, which means it may return after treatment, or becomes refractory, meaning it does not respond to treatment. Although new therapies have become available, treatment management can remain a challenge. EPCORE NHL-2 is a Phase 1b/2 open-label interventional trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics/biomarkers, immunogenicity, and preliminary efficacy of epcoritamab as a monotherapy and in combination with other standard of care agents in patients with B-cell non-Hodgkin’s lymphoma (B-NHL). The trial consists of two parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). The primary objective of Part 1 is safety, and the primary goal of Part 2 is preliminary efficacy. The primary endpoint was overall response rate (ORR) based on best overall response per Lugano criteria. MRD negativity was assessed as a secondary endpoint. Arm 10 of the EPCORE NHL-2 study enrolled 31 patients with R/R DLBCL, who were eligible for R-ICE and ASCT, and had received ≥1 prior line of treatment. At the time of data cutoff (December 18, 2024), median follow-up was 11 months (range, 6−15). Among the 31 patients treated with epcoritamab 48 mg + R-ICE, 61 percent were Ann Arbor stage III/IV, 42 percent had bulky disease ≥7 cm, 81 percent had one prior LOT (range, 1−3), and 65 percent had progressed within 12 months of first-line treatment. Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody® technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.i Epcoritamab (approved under the brand name EPKINLY® in the U.S. and Japan, and TEPKINLY® in the EU) has received regulatory approval in certain lymphoma indications in several territories. Where approved, epcoritamab is available as a readily accessible therapy without the need for reducing tumor burden (“debulking”). Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication. Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes five ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy (NCT04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with R/R FL (NCT05409066), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744), and a trial evaluating epcoritamab in combination with R2 compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658). The safety and efficacy of epcoritamab has not been established for these investigational uses. Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO®) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. The content above comes from the network. if any infringement, please contact us to modify.

$Genmab Announces Epcoritamab Investigational Combination Therapy Demonstrates High Response Rates in Patients with Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) Eligible for Autologous Stem Cell Transplantation (ASCT)$

Clinical ResultImmunotherapyDrug Approval

100 Deals associated with Epcoritamab

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Large B-cell lymphoma	Canada	AbbVie, Inc.	13 Oct 2023
Recurrent Grade 3b Follicular Lymphoma	Canada	AbbVie, Inc.	13 Oct 2023
Mediastinal large B-cell lymphoma	Japan	Genmab A/S	25 Sep 2023
Recurrent Follicular Lymphoma	Japan	Genmab A/S	25 Sep 2023
Refractory Follicular Lymphoma	Japan	Genmab A/S	25 Sep 2023
Diffuse large B-cell lymphoma recurrent	European Union	AbbVie Deutschland GmbH & Co. KG	22 Sep 2023
Diffuse large B-cell lymphoma recurrent	Iceland	AbbVie Deutschland GmbH & Co. KG	22 Sep 2023
Diffuse large B-cell lymphoma recurrent	Liechtenstein	AbbVie Deutschland GmbH & Co. KG	22 Sep 2023
Diffuse large B-cell lymphoma recurrent	Norway	AbbVie Deutschland GmbH & Co. KG	22 Sep 2023
Diffuse large B-cell lymphoma refractory	European Union	AbbVie Deutschland GmbH & Co. KG	22 Sep 2023
Diffuse large B-cell lymphoma refractory	Iceland	AbbVie Deutschland GmbH & Co. KG	22 Sep 2023
Diffuse large B-cell lymphoma refractory	Liechtenstein	AbbVie Deutschland GmbH & Co. KG	22 Sep 2023
Diffuse large B-cell lymphoma refractory	Norway	AbbVie Deutschland GmbH & Co. KG	22 Sep 2023
Diffuse Large B-Cell Lymphoma	United States	Genmab, Inc.	19 May 2023
High grade B-cell lymphoma	United States	Genmab, Inc.	19 May 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Refractory Grade 3a Follicular Lymphoma	Phase 3	United States	Genmab A/S	05 Feb 2024
Refractory Grade 3a Follicular Lymphoma	Phase 3	China	Genmab A/S	05 Feb 2024
Refractory Grade 3a Follicular Lymphoma	Phase 3	Japan	Genmab A/S	05 Feb 2024
Refractory Grade 3a Follicular Lymphoma	Phase 3	Australia	Genmab A/S	05 Feb 2024
Refractory Grade 3a Follicular Lymphoma	Phase 3	Belgium	Genmab A/S	05 Feb 2024
Refractory Grade 3a Follicular Lymphoma	Phase 3	Bulgaria	Genmab A/S	05 Feb 2024
Refractory Grade 3a Follicular Lymphoma	Phase 3	Canada	Genmab A/S	05 Feb 2024
Refractory Grade 3a Follicular Lymphoma	Phase 3	Croatia	Genmab A/S	05 Feb 2024
Refractory Grade 3a Follicular Lymphoma	Phase 3	Czechia	Genmab A/S	05 Feb 2024
Refractory Grade 3a Follicular Lymphoma	Phase 3	Denmark	Genmab A/S	05 Feb 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03625037 (EPCORE NHL-1, ASCO2025)	Phase 1/2	Large B-cell lymphoma Third line CD20	157	Epcoritamab	pfilzadbsn(bjtjhiyaae) = 12 D/C for reasons other than PD, most commonly adverse events (n=6, including the 2 pts with fatal infections above) unbmoplzdl (hljqegyvtz ) View more	Positive	30 May 2025
				Placebo
NCT05201248 (EPCORE NHL-4, ASCO2025)	Phase 1/2	Diffuse large B-cell lymphoma recurrent CD20	42	Epcoritamab 48 mg SC	ckuxddkxze(emrcbuckxk) = mtuwcxelog xscduvulyf (askxmsaitx ) View more	Positive	30 May 2025
NCT03625037 (EPCORE NHL-1, EHA2025)	Phase 2	Diffuse large B-cell lymphoma recurrent CD20	157	Epcoritamab monotherapy	thdhywlmmu(eideovwmib) = xvogmsdvxn psltaqkzuk (wscccbqhap ) View more	Positive	22 May 2025
NCT05283720 (EPCORE NHL-5, EHA2025)	Phase 1/2	Diffuse Large B-Cell Lymphoma First line CD20+ \| MYC \| BCL-2 ... View more	37	Epcoritamab + Polatuzumab Vedotin + Rituximab + Cyclophosphamide + Doxorubicin + Prednisone	vpkrzmakmw(rvenbbsvee) = Three (8%) pts discontinued epcor and 2 (5%) discontinued pola-R-CHP due to an AE. The most common G3/4 AEs were neutropenia (65%), anemia (19%), and leukopenia (11%). One pt had a fatal TEAE (urosepsis) not considered related to epcor. CRS occurred in 51% of pts, all low grade (35% G1, 16% G2, no G3+), and as expected, primarily occurred after the first full dose of epcor (C1D15). All CRS events resolved, with median time to resolution of 2 D (range: 1-6). No ICANS was observed. zpvunandpy (onusbrznea )	Positive	14 May 2025
NCT04663347 (EPCORE NHL-2, EHA2025)	Phase 1/2	Diffuse Large B-Cell Lymphoma First line CD3 \| CD20	28	Epcoritamab + R-miniCHOP	jdcowqnyue(ypffhlxkwp) = sctexygfma nshulcnsll (tilheywudf ) View more	Positive	14 May 2025
				R-miniCHOP	jdcowqnyue(ypffhlxkwp) = ymvxihsiab nshulcnsll (tilheywudf ) View more
NCT03625037 (EPCORE NHL-1, EHA2025)	Phase 1/2	Follicular Lymphoma Second line CD3 \| CD20	108	Epcoritamab + Rituximab + Lenalidomide	agaprvuxxq(rcnukledsm) = yitsusgsfc tslmyqqhen (ifvnyjpzpe ) View more	Positive	14 May 2025
				Tafasitamab + Rituximab + Lenalidomide	agaprvuxxq(rcnukledsm) = hxwadvmppx tslmyqqhen (ifvnyjpzpe ) View more
NCT04663347 (NHL-2, EHA2025)	Phase 1/2	Follicular Lymphoma \| Refractory Follicular Lymphoma \| T-cell/histiocyte rich large B-cell lymphoma ... CD3 \| CD20 View more	31	Epcoritamab 48 mg + R-ICE	vckdldoqnt(mtafilxvxf) = 68% msxfipnuky (voupswiqzm ) View more	-	14 May 2025
NCT04663347 (EPCORE NHL-2, EHA2025)	Phase 1/2	Diffuse Large B-Cell Lymphoma Second line CD3 \| CD20	-	Epcoritamab + R-DHAX/C or R-ICE	nwqbbwodyr(sgcgevnxte) = norzsxvovy dvtvfecwqb (gmufnzsjjn, 50.9 - 74.6) View more	Positive	14 May 2025
				R-DHAX/C or R-ICE	nwqbbwodyr(sgcgevnxte) = iibehgipup dvtvfecwqb (gmufnzsjjn, 9.6 - 33.1) View more
NCT04663347 (EPCORE NHL-2, EHA2025)	Phase 1/2	Refractory Follicular Lymphoma Third line CD3 \| CD20	111	Epcoritamab+R2	ycwxwjlnin(czvsubzlxo) = qlzvlkberu wobufvdsdy (hvqpwrncyk ) View more	Positive	14 May 2025
				Usual Care (R2)	ycwxwjlnin(czvsubzlxo) = efmhcfwotu wobufvdsdy (hvqpwrncyk ) View more
NCT03625037 (EPCORE NHL-1 FL, EHA2025)	Phase 1/2	Refractory Follicular Lymphoma Third line CD20+	149	Epcoritamab	cvjpxjqirt(iatyacotfg) = 14.3% of pts on ≥2 y of tx (n=35) jhssivjyrr (fcscqkqcjw ) View more	Positive	14 May 2025

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