AbbVie Announces Updated Results From Phase 2 EPCORE® NHL-6 Study Evaluating the Potential for Outpatient Monitoring of Epcoritamab in Patients With Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
AbbVie (NYSE:ABBV) announced updated results from the Phase 2 EPCORE® NHL-6 trial evaluating epcoritamab, a subcutaneously administered T-cell engaging bispecific antibody, in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
The study demonstrated promising results with 92% of patients successfully monitored in outpatient settings. Key findings include low-grade cytokine release syndrome in 40.2% of patients and immune cell-associated neurotoxicity syndrome in 7.6% of patients, with all events resolving without treatment discontinuation.
The trial showed strong efficacy with an overall response rate of 64.3% and complete response rate of 47.6% in patients after one prior therapy line. For patients with two or more prior treatments, response rates were 60.0% and 38.0% respectively.
AbbVie (NYSE:ABBV) ha comunicato risultati aggiornati dello studio di Fase 2 EPCORE® NHL-6 su epcoritamab, un anticorpo bispecifico che attiva le cellule T e viene somministrato per via sottocutanea, in pazienti con linfoma diffuso a grandi cellule B (DLBCL) recidivante/refrattario.
Lo studio ha mostrato risultati promettenti: il 92% dei pazienti è stato seguito con successo in regime ambulatoriale. I principali riscontri includono una sindrome da rilascio di citochine di grado lieve nel 40,2% dei casi e una sindrome neurotossica associata a cellule immunitarie nel 7,6% dei pazienti; tutti gli eventi si sono risolti senza sospendere il trattamento.
Il trial ha evidenziato una solida efficacia con un tasso di risposta globale del 64,3% e un tasso di risposta completa del 47,6% nei pazienti dopo una sola linea di terapia precedente. Nei pazienti con due o più trattamenti pregressi, i tassi di risposta sono stati rispettivamente del 60,0% e del 38,0%.
AbbVie (NYSE:ABBV) anunció resultados actualizados del ensayo de Fase 2 EPCORE® NHL-6 que evalúa epcoritamab, un anticuerpo bispecífico activador de células T administrado por vía subcutánea, en pacientes con linfoma difuso de células B de gran tamaño (DLBCL) en recaída/refractario.
El estudio mostró resultados prometedores: el 92% de los pacientes fueron monitorizados con éxito de forma ambulatoria. Los hallazgos clave incluyen síndrome de liberación de citoquinas de grado leve en el 40,2% de los pacientes y síndrome neurotóxico asociado a células inmunitarias en el 7,6%; todos los episodios se resolvieron sin interrumpir el tratamiento.
El ensayo demostró una fuerte eficacia con una tasa de respuesta global del 64,3% y una tasa de respuesta completa del 47,6% en pacientes tras una línea de terapia previa. En pacientes con dos o más tratamientos previos, las tasas de respuesta fueron del 60,0% y del 38,0%, respectivamente.
AbbVie (NYSE:ABBV)는 재발/불응성 미만세포 B세포 확산성 거대세포 림프종(DLBCL) 환자를 대상으로 피하 주사형 T세포 유도 이중특이항체 에프코리타맙(epcoritamab)을 평가한 2상 EPCORE® NHL-6 시험의 업데이트된 결과를 발표했습니다.
연구는 유망한 결과를 보였으며, 환자의 92%가 외래에서 성공적으로 모니터링되었습니다. 주요 소견으로는 환자의 40.2%에서 경증 사이토카인 방출 증후군, 7.6%에서 면역세포 관련 신경독성 증후군이 관찰되었으나 모든 사건이 치료 중단 없이 회복되었습니다.
시험은 1차 치료 후 환자에서 전체 반응률 64.3%, 완전 반응률 47.6%로 높은 효능을 보였습니다. 이전 치료가 2회 이상인 환자에서는 각각 60.0% 및 38.0%의 반응률을 기록했습니다.
AbbVie (NYSE:ABBV) a annoncé les résultats mis à jour de l'essai de phase 2 EPCORE® NHL‑6 évaluant l'epcoritamab, un anticorps bispécifique engageant les cellules T et administré par voie sous‑cutanée, chez des patients atteints d'un lymphome diffus à grandes cellules B (DLBCL) en rechute/réfractaire.
L'étude a montré des résultats prometteurs : 92% des patients ont été suivis avec succès en ambulatoire. Les principaux constats incluent un syndrome de libération de cytokines de bas grade chez 40,2% des patients et un syndrome neurotoxique associé aux cellules immunitaires chez 7,6% ; tous les événements se sont résolus sans interruption du traitement.
L'essai a démontré une forte efficacité avec un taux de réponse global de 64,3% et un taux de réponse complète de 47,6% chez les patients après une ligne de traitement antérieure. Pour les patients ayant reçu deux traitements ou plus, les taux de réponse étaient de 60,0% et 38,0% respectivement.
AbbVie (NYSE:ABBV) hat aktualisierte Ergebnisse der Phase‑2‑Studie EPCORE® NHL‑6 vorgestellt, die epcoritamab untersucht – einen subkutan verabreichten, T‑Zellen aktivierenden bispezifischen Antikörper – bei Patienten mit rezidivierendem/refraktärem diffus großzelligem B‑Zell‑Lymphom (DLBCL).
Die Studie zeigte vielversprechende Resultate: 92% der Patienten konnten erfolgreich ambulant überwacht werden. Wichtige Befunde sind eine meist geringgradige Zytokinfreisetzungssyndrom bei 40,2% und ein immunzellassoziiertes Neurotoxizitäts-Syndrom bei 7,6% der Patienten; alle Ereignisse bildeten sich zurück, ohne dass die Behandlung abgebrochen werden musste.
Die Studie ergab eine starke Wirksamkeit mit einer Gesamtansprechrate von 64,3% und einer Vollansprechrate von 47,6% bei Patienten nach einer vorherigen Therapielinie. Bei Patienten mit zwei oder mehr Vorbehandlungen lagen die Ansprechraten bei 60,0% bzw. 38,0%.
- None.
- 40.2% of patients experienced cytokine release syndrome events
- 7.6% of patients developed immune cell-associated neurotoxicity syndrome
- Treatment not yet approved for outpatient or second-line settings
Insights
AbbVie's epcoritamab shows promise for outpatient DLBCL treatment with manageable safety profile and encouraging efficacy after limited prior therapy.
The updated Phase 2 EPCORE NHL-6 trial results for epcoritamab represent a potentially significant advancement in the treatment paradigm for relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The data demonstrates that 92% of patients could receive their first full dose of epcoritamab in an outpatient setting, with manageable cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) events.
This outpatient administration capability is particularly noteworthy because most bispecific antibody therapies for DLBCL typically require hospital admission for monitoring after initial doses due to CRS risk. The observed CRS rate of 40.2% was primarily low-grade, with all events resolving (median resolution time: 2 days) and none leading to treatment discontinuation. Similarly, ICANS occurred in just 7.6% of patients, was mostly low-grade, and all cases resolved with no treatment discontinuations.
The efficacy data is especially compelling for second-line treatment, showing an overall response rate of 64.3% and complete response rate of 47.6% in patients who had received only one prior line of therapy. This suggests epcoritamab could potentially be valuable earlier in the treatment sequence than its current approval (after ≥2 prior therapies).
For DLBCL patients who have progressed after initial therapy, these results indicate epcoritamab might offer a more convenient treatment option without compromising safety. The ability to administer in community settings could significantly expand access, particularly for patients in rural areas with limited access to specialized cancer centers. While this specific outpatient administration protocol isn't yet FDA-approved, these results will likely inform future regulatory discussions.
- Data presented at 13th Society of Hematologic Oncology (SOHO) Annual Meeting
In the study, 88 patients received the first full dose (48 mg) of epcoritamab monotherapy. Of these, 81 patients (
"The EPCORE® NHL-6 trial results are notable, as current bispecific antibody treatments for relapsed and refractory diffuse large B-cell lymphoma patients may require in-hospital monitoring for cytokine release syndrome after certain initial doses and as needed after subsequent doses," said Jeff Sharman, M.D., disease chair, hematology research, Sarah Cannon Research Institute (SCRI) at Willamette Valley Cancer Institute in Eugene,
The study also showed an overall response rate (ORR) of
"The updated EPCORE® NHL-6 trial findings presented at the Society of Hematologic Oncology Annual Meeting suggest that treatment of relapsed/refractory diffuse large B-cell lymphoma with epcoritamab can be safe in the outpatient setting. This potential shift to outpatient care could help improve access to treatment," said Svetlana Kobina, M.D., Ph.D, vice president, oncology medical affairs, AbbVie. "AbbVie remains committed to building on our leadership in blood cancer, which includes advancing research with our partner Genmab, that firmly establishes the impact of investigational epcoritamab in successive lines of treatment across B-cell malignancies."
DLBCL is the most common type of non-Hodgkin's lymphoma (NHL) worldwide, accounting for approximately 25
The use of epcoritamab in an outpatient setting for the first full dose in R/R DLBCL and as monotherapy in DLBCL in the second-line setting has not been approved by the
About the EPCORE® NHL-6 Trial
EPCORE® NHL-6 is a Phase 2 open-label clinical trial evaluating the safety of outpatient administration of subcutaneous epcoritamab as monotherapy in adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). The primary objective of the trial was to assess adverse events within three months of treatment initiation with epcoritamab monotherapy. The primary outcome measures were the percentage of participants experiencing Grade 3 or higher cytokine release syndrome (CRS) events, immune cell-associated neurotoxicity syndrome (ICANS) events, and/or neurotoxicity (Ntox) events. Secondary outcomes included responses to treatment as determined by Lugano 2014 criteria and assessed by investigators.
EPCORE® NHL-6 enrolled 92 patients with R/R DLBCL who had received at least one prior line of systemic therapy, including at least one anti-CD20 monoclonal antibody-containing therapy. At the time of data cutoff (January 15, 2025), 92 patients had received ≥1 dose of epcoritamab (community: n=41; academic: n=51). Median follow-up was 7.6 months (range, 6.0-9.2) and
About Epcoritamab
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.7 Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies share commercial responsibilities in the
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 lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658). The safety and efficacy of epcoritamab have not been established for these investigational uses.
EPKINLY® (epcoritamab-bysp)
What is EPKINLY?
EPKINLY is a prescription medicine used to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, or follicular lymphoma (FL) that has come back or that did not respond to previous treatment after receiving 2 or more treatments. EPKINLY is approved based on patient response data. Studies are ongoing to confirm the clinical benefit of EPKINLY. It is not known if EPKINLY is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Important Warnings—EPKINLY can cause serious side effects, including:
- Cytokine release syndrome (CRS), which is common during treatment with EPKINLY and can be serious or life-threatening. To help reduce your risk of CRS, you will receive EPKINLY on a step-up dosing schedule (when you receive 2 or 3 smaller step-up doses of EPKINLY before your first full dose during your first cycle of treatment), and you may also receive other medicines before and for 3 days after receiving EPKINLY. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule.
- Neurologic problems that can be serious, and can be life-threatening and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY.
People with DLBCL or high-grade B-cell lymphoma should be hospitalized for 24 hours after receiving their first full dose of EPKINLY on day 15 of cycle 1 due to the risk of CRS and neurologic problems.
Tell your healthcare provider or get medical help right away if you develop a fever of 100.4°F (38°C) or higher; dizziness or lightheadedness; trouble breathing; chills; fast heartbeat; feeling anxious; headache; confusion; shaking (tremors); problems with balance and movement, such as trouble walking; trouble speaking or writing; confusion and disorientation; drowsiness, tiredness or lack of energy; muscle weakness; seizures; or memory loss. These may be symptoms of CRS or neurologic problems. If you have any symptoms that impair consciousness, do not drive or use heavy machinery or do other dangerous activities until your symptoms go away.
EPKINLY can cause other serious side effects including:
- Infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment and treat you as needed if you develop an infection. You should receive medicines from your healthcare provider before you start treatment to help prevent infection. Tell your healthcare provider right away if you develop any symptoms of infection during treatment, including fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, or feeling weak or generally unwell.
- Low blood cell counts, which can be serious or severe. Your healthcare provider will check your blood cell counts during treatment. EPKINLY may cause low blood cell counts, including low white blood cells (neutropenia), which can increase your risk for infection; low red blood cells (anemia), which can cause tiredness and shortness of breath; and low platelets (thrombocytopenia), which can cause bruising or bleeding problems.
Your healthcare provider will monitor you for symptoms of CRS, neurologic problems, infections, and low blood cell counts during treatment with EPKINLY. Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects.
Before you receive EPKINLY, tell your healthcare provider about all your medical conditions, including if you have an infection, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. If you receive EPKINLY while pregnant, it may harm your unborn baby. If you are a female who can become pregnant, your healthcare provider should do a pregnancy test before you start treatment with EPKINLY and you should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY.
In DLBCL or high-grade B-cell lymphoma, the most common side effects of EPKINLY include CRS, tiredness, muscle and bone pain, injection site reactions, fever, stomach-area (abdominal) pain, nausea, and diarrhea. The most common severe abnormal laboratory test results include decreased white blood cells, decreased red blood cells, and decreased platelets.
In follicular lymphoma the most common side effects of EPKINLY include injection site reactions, CRS, COVID-19, tiredness, upper respiratory tract infections, muscle and bone pain, rash, diarrhea, fever, cough, and headache. The most common severe abnormal laboratory test results include decreased white blood cells and decreased red blood cells.
These are not all of the possible side effects of EPKINLY. Call your doctor for medical advice about side effects. You are encouraged to report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622).
Please see Full Prescribing Information and Medication Guide, including Important Warnings.
Globally, prescribing information varies; refer to the individual country product label for complete information.
About AbbVie in Oncology
AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines.
Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit http://www.abbvie.com/oncology.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube.
AbbVie Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
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2 | Padala, et al. Diffuse Large B-Cell Lymphoma. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan. 2023 Apr 24. |
3 | Leukemia and Lymphoma Society. Diffuse Large B-Cell Lymphoma (DLBCL). Accessed November 2024. https://www.lls.org/research/diffuse-large-b-cell-lymphoma-dlbcl |
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5 | Kanas, et al. Epidemiology of Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL) in |
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7 | Engelberts PJ, Hiemstra IH, de Jong B, et al. DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing. EBioMedicine. 2020;52:102625. DOI: 10.1016/j.ebiom.2019.102625. |
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FAQ
What are the key findings from AbbVie's (ABBV) EPCORE NHL-6 trial for epcoritamab?
What is the success rate of epcoritamab in treating DLBCL after one prior therapy?
What are the main side effects reported in AbbVie's EPCORE NHL-6 trial?
How many DLBCL patients can be treated with epcoritamab in an outpatient setting?
What is the current approval status of epcoritamab for DLBCL treatment?
