EPKINLY® (epcoritamab) Approved by Japan Ministry of Health, Labour and Welfare for Additional Indication as a Treatment for Relapsed or Refractory Follicular Lymphoma
Genmab A/S (Nasdaq: GMAB) announced that the Japan Ministry of Health, Labour and Welfare has approved EPKINLY® (epcoritamab) for treating patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received two or more prior lines of therapy. This approval is based on results from two Phase 1/2 EPCORE® clinical trials, which demonstrated strong and durable efficacy in patients.
EPKINLY is the first and only T-cell engaging bispecific antibody administered subcutaneously approved in Japan to treat both R/R FL and R/R large B-cell lymphomas. FL accounts for 20-30% of non-Hodgkin’s lymphoma (NHL) cases, with approximately 19,000 patients living with FL in Japan. FL is considered incurable with current therapies, and patients often relapse, leading to shorter remission periods.
The approval is supported by data from the EPCORE NHL-1 and EPCORE NHL-3 trials. In the global EPCORE NHL-1 trial, the overall response rate (ORR) was 82%, with a complete response (CR) rate of 62.5%. In the Japanese EPCORE NHL-3 trial, the ORR was 95.2%, with a CR rate of 76.2%. Common adverse events included cytokine release syndrome (CRS) and injection site reactions.
EPKINLY is the only bispecific antibody approved in the U.S., European Union, and Japan for dual indications in treating B-cell malignancies.
Genmab A/S (Nasdaq: GMAB) ha annunciato che il Ministero della Salute, del Lavoro e del Welfare del Giappone ha approvato EPKINLY® (epcoritamab) per il trattamento dei pazienti con linfoma follicolare (FL) recidivante o refrattario (R/R) che hanno ricevuto due o più linee di terapia precedenti. Questa approvazione si basa sui risultati di due studi clinici di Fase 1/2 EPCORE®, che hanno dimostrato un'efficacia forte e duratura nei pazienti.
EPKINLY è il primo e unico anticorpo bispecifico che coinvolge le cellule T somministrato per via sottocutanea approvato in Giappone per trattare sia il FL R/R che i linfomi a grandi cellule B R/R. Il FL rappresenta il 20-30% dei casi di linfoma non-Hodgkin (NHL), con circa 19.000 pazienti che convivono con il FL in Giappone. Il FL è considerato incurabile con le terapie attuali e i pazienti spesso recidivano, portando a periodi di remissione più brevi.
L'approvazione è supportata dai dati provenienti dagli studi EPCORE NHL-1 e EPCORE NHL-3. Nello studio globale EPCORE NHL-1, il tasso di risposta globale (ORR) è stato dell'82%, con un tasso di risposta completa (CR) del 62,5%. Nello studio giapponese EPCORE NHL-3, l'ORR è stato del 95,2%, con un tasso di CR del 76,2%. Gli eventi avversi comuni includevano la sindrome da rilascio di citochine (CRS) e reazioni nel sito di iniezione.
EPKINLY è l'unico anticorpo bispecifico approvato negli Stati Uniti, nell'Unione Europea e in Giappone per indicazioni duali nel trattamento delle neoplasie delle cellule B.
Genmab A/S (Nasdaq: GMAB) anunció que el Ministerio de Salud, Trabajo y Bienestar de Japón ha aprobado EPKINLY® (epcoritamab) para el tratamiento de pacientes con linfoma folicular (FL) en recaída o refractario (R/R) que han recibido dos o más líneas de terapia previas. Esta aprobación se basa en los resultados de dos ensayos clínicos de Fase 1/2 EPCORE®, que demostraron una eficacia fuerte y duradera en los pacientes.
EPKINLY es el primer y único anticuerpo bispecífico que involucra células T administrado por vía subcutánea aprobado en Japón para tratar tanto el FL R/R como los linfomas de células B grandes R/R. El FL representa el 20-30% de los casos de linfoma no Hodgkin (NHL), con aproximadamente 19,000 pacientes viviendo con FL en Japón. El FL se considera incurable con las terapias actuales, y los pacientes a menudo recaen, lo que lleva a períodos de remisión más cortos.
La aprobación está respaldada por datos de los ensayos EPCORE NHL-1 y EPCORE NHL-3. En el ensayo global EPCORE NHL-1, la tasa de respuesta global (ORR) fue del 82%, con una tasa de respuesta completa (CR) del 62.5%. En el ensayo japonés EPCORE NHL-3, la ORR fue del 95.2%, con una tasa de CR del 76.2%. Los eventos adversos comunes incluyeron síndrome de liberación de citoquinas (CRS) y reacciones en el sitio de inyección.
EPKINLY es el único anticuerpo bispecífico aprobado en EE. UU., la Unión Europea y Japón para indicaciones duales en el tratamiento de malignidades de células B.
Genmab A/S (Nasdaq: GMAB)는 일본 보건복지부가 EPKINLY® (epcoritamab)를 두 가지 이상의 이전 치료를 받은 재발성 또는 내성 (R/R) 여포 림프종 (FL) 환자 치료를 위해 승인했다고 발표했습니다. 이 승인은 두 개의 1/2상 EPCORE® 임상 시험 결과를 기반으로 하며, 환자에서 강력하고 지속적인 효능을 입증했습니다.
EPKINLY는 일본에서 R/R FL과 R/R 대형 B세포 림프종 모두를 치료하기 위해 피하 주사로 승인된 첫 번째이자 유일한 T세포 관여 이중 특이성 항체입니다. FL은 비호지킨 림프종 (NHL) 사례의 20-30%를 차지하며, 일본에서 FL을 앓고 있는 환자는 약 19,000명입니다. FL은 현재 치료로는 치유가 불가능하며, 환자들은 종종 재발하여 짧은 관해 기간으로 이어집니다.
이 승인은 EPCORE NHL-1 및 EPCORE NHL-3 시험의 데이터를 통해 지원됩니다. 글로벌 EPCORE NHL-1 시험에서 전체 반응률 (ORR)은 82%였으며, 완전 반응 (CR)률은 62.5%였습니다. 일본의 EPCORE NHL-3 시험에서 ORR은 95.2%였으며, CR률은 76.2%였습니다. 일반적인 부작용으로는 사이토카인 방출 증후군 (CRS) 및 주사 부위 반응이 포함되었습니다.
EPKINLY는 B세포 악성종양 치료를 위한 이중 적응증으로 미국, 유럽연합 및 일본에서 승인된 유일한 이중 특이성 항체입니다.
Genmab A/S (Nasdaq: GMAB) a annoncé que le ministère japonais de la Santé, du Travail et du Bien-être a approuvé EPKINLY® (epcoritamab) pour le traitement des patients atteints de lymphome folliculaire (FL) récurrent ou réfractaire (R/R) ayant reçu deux lignes de traitement ou plus. Cette approbation est basée sur les résultats de deux essais cliniques de phase 1/2 EPCORE®, qui ont démontré une efficacité forte et durable chez les patients.
EPKINLY est le premier et unique anticorps bispécifique engageant les cellules T administré par voie sous-cutanée approuvé au Japon pour traiter à la fois le FL R/R et les lymphomes à grandes cellules B R/R. Le FL représente 20 à 30 % des cas de lymphome non hodgkinien (NHL), avec environ 19 000 patients vivant avec le FL au Japon. Le FL est considéré comme incurable avec les thérapies actuelles, et les patients rechutent souvent, entraînant des périodes de rémission plus courtes.
L'approbation est soutenue par des données des essais EPCORE NHL-1 et EPCORE NHL-3. Dans l'essai mondial EPCORE NHL-1, le taux de réponse global (ORR) était de 82 %, avec un taux de réponse complète (CR) de 62,5 %. Dans l'essai japonais EPCORE NHL-3, l'ORR était de 95,2 %, avec un taux de CR de 76,2 %. Les événements indésirables courants comprenaient le syndrome de libération de cytokines (CRS) et des réactions au site d'injection.
EPKINLY est le seul anticorps bispécifique approuvé aux États-Unis, dans l'Union européenne et au Japon pour des indications doubles dans le traitement des malignités des cellules B.
Genmab A/S (Nasdaq: GMAB) gab bekannt, dass das japanische Ministerium für Gesundheit, Arbeit und Wohlfahrt EPKINLY® (epcoritamab) zur Behandlung von Patienten mit rezidiviertem oder refraktärem (R/R) follikulärem Lymphom (FL), die zwei oder mehr vorherige Therapie-Linien erhalten haben, genehmigt hat. Diese Genehmigung basiert auf den Ergebnissen von zwei Phase 1/2 EPCORE®-Klinikstudien, die eine starke und dauerhafte Wirksamkeit bei den Patienten zeigten.
EPKINLY ist der erste und einzige T-Zell-engagierende bispezifische Antikörper, der subkutan verabreicht wurde und in Japan zur Behandlung sowohl von R/R FL als auch von R/R großen B-Zell-Lymphomen genehmigt wurde. FL macht 20-30% der Fälle von Non-Hodgkin-Lymphom (NHL) aus, wobei etwa 19.000 Patienten in Japan mit FL leben. FL gilt mit den derzeitigen Therapien als unheilbar, und Patienten treten häufig in eine Rückfallphase, was zu kürzeren Remissionszeiten führt.
Die Genehmigung wird durch Daten aus den EPCORE NHL-1- und EPCORE NHL-3-Studien unterstützt. In der globalen EPCORE NHL-1-Studie betrug die Gesamtansprechrate (ORR) 82%, mit einer vollständigen Ansprechrate (CR) von 62,5%. In der japanischen EPCORE NHL-3-Studie lag die ORR bei 95,2%, mit einer CR-Rate von 76,2%. Häufige unerwünschte Ereignisse umfassten das Zytokinfreisetzungssyndrom (CRS) und Reaktionen an der Injektionsstelle.
EPKINLY ist der einzige bispezifische Antikörper, der in den USA, der Europäischen Union und Japan für duale Indikationen zur Behandlung von B-Zell-Malignitäten genehmigt wurde.
- Japan approval for EPKINLY expands its market reach.
- High ORR (82%) and CR rate (62.5%) in global trial.
- High ORR (95.2%) and CR rate (76.2%) in Japanese trial.
- EPKINLY is the first T-cell engaging bispecific antibody in Japan for R/R FL and R/R large B-cell lymphomas.
- High incidence of adverse events, including CRS (66.4%) in global trial and (90.5%) in Japanese trial.
Insights
The Japanese approval of EPKINLY for follicular lymphoma marks a strategic expansion in one of the world's largest pharmaceutical markets, with approximately 19,000 FL patients in Japan. The drug's exceptional efficacy profile stands out with a remarkable 95.2% overall response rate in Japanese patients, significantly higher than current standards of care.
The achievement of MRD negativity in 88.9% of Japanese patients is particularly significant as it indicates the virtual elimination of detectable cancer cells, potentially leading to longer remission periods. This is important in FL treatment, where each relapse typically results in shorter remission periods and increased resistance to therapy.
EPKINLY's subcutaneous administration offers a significant competitive advantage over intravenous alternatives, potentially improving patient compliance and reducing healthcare resource utilization. The dual indication for both FL and large B-cell lymphomas positions Genmab strategically in the B-cell malignancies market, creating a broader revenue opportunity.
The safety profile, while showing manageable cytokine release syndrome rates, demonstrates improved tolerability with the 3-step dosing regimen, reducing CRS incidence from 66.4% to 48.8%. This optimization could enhance market adoption and patient acceptance.
The synchronized approval across major markets (US, EU, and Japan) within a year strengthens Genmab's global commercial position and suggests strong regulatory confidence in EPKINLY's clinical profile. This expansion in Japan could serve as a catalyst for broader adoption in the Asia-Pacific region.
- Approval based on results from two Phase 1/2 EPCORE® clinical trials, which demonstrated strong and durable efficacy in patients with relapsed or refractory (R/R) follicular lymphoma (FL) who had received two or more lines of systemic therapy
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EPKINLY is the first and only T-cell engaging bispecific antibody administered subcutaneously approved in
Japan to treat both R/R FL and R/R large B-cell lymphomas, after two or more prior lines of therapy -
EPKINLY is the only bispecific antibody approved with a dual indication for the treatment of certain B-cell malignancies in
the United States , European Union andJapan
FL is typically an indolent (or slow growing) form of non-Hodgkin’s lymphoma (NHL) that arises from B-lymphocytes and is the second most common form of NHL, accounting for 20-30 percent of all cases.i There are approximately 19,000 patients currently living with FL in
“In the treatment of follicular lymphoma, where options become limited with each relapse, there remains a high unmet need for third-line and subsequent therapies in the absence of a clear standard of care,” said Dr. Koji Izutsu, Head of the Department of Hematology, National Cancer Center Hospital, who served as the principal investigator of the Japanese Phase 1/2 clinical trial (EPCORE NHL-3 trial). “The responses and tolerability demonstrated in this trial support the potential of epcoritamab to become an important option in future treatment strategies for relapsed/refractory follicular lymphoma.”
The approval is based on results from the global Phase 1/2 EPCORE NHL-1 and the Japanese Phase 1/2 EPCORE NHL-3 clinical trials, which were open-label, multicenter studies to evaluate the safety and efficacy of EPKINLY as a monotherapy in patients with R/R mature B-cell non-Hodgkin’s lymphoma, including FL. In the Japanese trial, a 2-step step-up dosing (SUD) regimen was used. In the global trial, two different dose escalation methods were used – 2-step and 3-step SUD regimens – to mitigate a common adverse reaction from T-cell engaging cancer treatments known as cytokine release syndrome (CRS).
EPCORE® NHL-1 Global Clinical Trial Results
Among the 128 evaluable patients with R/R FL in the EPCORE NHL-1 trial, the overall response rate (ORR) and the complete response (CR) rate were 82 percent (95 percent CI: 74.3-88.3) and 62.5 percent, respectively (data cut-off: April 21, 2023). Ninety-one patients were evaluable for a minimal residual disease (MRD) analysis, with 67 percent of patients achieving MRD negativity. Additionally, more than half of patients who responded to treatment in the study remained responsive to treatment at the time of data analysis (i.e., at a median follow-up of 14.8 months, median duration of response (DoR) was not reached).
Among the patients who received EPKINLY with the 2-step SUD regimen (n=128), adverse events were observed in 119 patients (93 percent). The most common treatment-emergent adverse events (TEAEs) (≥20 percent) included CRS (66.4 percent) and injection site reactions (36.7 percent).
As part of a separate dose-optimization cohort in the trial, a 3-step SUD regimen was evaluated in 86 patients with FL (Grades 1 to 3A). Adverse events were observed in 78 patients (90.7 percent). The most common TEAEs included CRS (48.8 percent) and injection site reactions (26.7 percent).
EPCORE® NHL-3 Japanese Clinical Trial Results
Among the 21 evaluable patients with R/R FL in the Japanese trial, with a median follow up of 21.2 months, the ORR and the CR rate were 95.2 percent (95 percent CI: 76.2-99.9) and 76.2 percent, respectively. Additionally, 88.9 percent of patients achieved MRD negativity (n=18).
Among patients who received EPKINLY with the 2-step SUD regimen, the most common TEAEs included CRS (90.5 percent), injection site reactions (71.4 percent), rash (28.6 percent), neutropenia (28.6 percent), increased alanine aminotransferase (23.8 percent) and increased aspartate aminotransferase (23.8 percent).
“Patients living with relapsed or refractory follicular lymphoma in
About the EPCORE® NHL-1 Trial
EPCORE® NHL-1 is an open-label, multi-center safety and preliminary efficacy trial of epcoritamab that consists of three parts: a dose escalation part; an expansion part; and an optimization part. The trial was designed to evaluate subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma (B-NHL), including FL. In the expansion part, additional patients were enrolled to further explore the safety and efficacy of epcoritamab in three cohorts of patients with different types of relapsed/refractory B-NHLs who have limited therapeutic options. The expansion part generated pivotal data from patients with FL and DLBCL. The optimization part evaluated additional CRS mitigation strategies during cycle 1. The primary endpoint of the expansion part was overall response rate (ORR) as assessed by an Independent Review Committee. Secondary efficacy endpoints included duration of response (DoR), complete response (CR) rate, duration of complete response (DoCR), progression-free survival (PFS), and time to response as determined by the Lugano criteria. Overall survival (OS), time to next therapy, and rate of minimal residual disease (MRD) negativity were also evaluated as secondary efficacy endpoints. The primary endpoint of the optimization part was the rate of ≥ Grade 2 CRS events and all grade CRS events from first dose of epcoritamab through 7 days following administration of the second full dose of epcoritamab.
About the EPCORE® NHL-3 Trial
EPCORE® NHL-3 is an open-label, multi-center safety and efficacy trial of epcoritamab that consists of a Phase 1 first-in-human dose escalation part and a Phase 2 expansion part. The Phase 2 expansion part evaluated subcutaneous administration of epcoritamab in Japanese patients with relapsed, progressive, or refractory mature B-cell NHL, including FL. The primary endpoint of the expansion part was ORR as assessed by IRC, and secondary efficacy endpoints included DOR, CR rate, DoCR, PFS, and time to response based on the Lugano criteria.
About EPKINLY® (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.vi
Epcoritamab (approved under the brand name EPKINLY® 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 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. Please visit www.clinicaltrials.gov for more information.
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 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 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 Genmab
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 more than 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
This Media Release contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the
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i Lymphoma Research Foundation official website. https://lymphoma.org/aboutlymphoma/nhl/fl/. Accessed November 2024.
ii Portal Site of Official Statistics of
iii Ghione P, Palomba ML, Ghesquieres H, et al. Treatment patterns and outcomes in relapsed/refractory follicular lymphoma: results from the international SCHOLAR-5 study. Haematologica. 2023;108(3):822-832. doi: 10.3324/haematol.2022.281421.
iv Rivas-Delgado A, Magnano L, Moreno-Velázquez M, et al. Response duration and survival shorten after each relapse in patients with follicular lymphoma treated in the rituximab era. Br J Haematol. 2018;184(5):753-759. doi:10.1111/bjh.15708.
v Al-Tourah AJ, Gill KK, Chhanabhai M, et al. Population-based analysis of incidence and outcome of transformed non-Hodgkin's lymphoma. J Clin Oncol. 2008 Nov 10;26(32):5165-9. doi: 10.1200/JCO.2008.16.0283. Epub 2008 Oct 6. PMID: 18838711.
vi Engelberts PJ, 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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Source: Genmab A/S
FAQ
What is EPKINLY's new indication approved by the Japan Ministry of Health?
What were the results of the EPCORE NHL-1 global clinical trial for GMAB?
How did EPKINLY perform in the Japanese EPCORE NHL-3 trial?
What adverse events were observed in the EPCORE NHL-1 global trial?
What is significant about EPKINLY's approval in Japan?
How many patients are affected by follicular lymphoma in Japan?
What is the significance of EPKINLY's dual indication approval?
