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Investigational Epcoritamab (DuoBody® CD3xCD20) Combination Therapy Demonstrates High Response Rates in Clinical Trial of Patients With Relapsed or Refractory (R/R) Follicular Lymphoma (FL)

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Genmab A/S (GMAB) announced promising results from the Phase 1b/2 EPCORE® NHL-2 trial evaluating epcoritamab combination therapy in relapsed/refractory follicular lymphoma patients. The study demonstrated remarkable efficacy with a 96% overall response rate and 87% complete response rate among 111 patients after two years median follow-up.

Key outcomes include 80% progression-free survival at 21 months and 90% overall survival rate at two years. The treatment showed durable responses with 89% of complete responders maintaining their response at 18 months. The FDA recently granted breakthrough therapy designation for this combination therapy.

Notable adverse events included neutropenia (62%) and cytokine release syndrome (51%, mostly low-grade). COVID-19 affected 57% of patients, leading to treatment discontinuation in 13% of cases, with five fatal outcomes.

Genmab A/S (GMAB) ha annunciato risultati promettenti dallo studio di fase 1b/2 EPCORE® NHL-2 che valuta la terapia combinata con epcoritamab nei pazienti con linfoma follicolare in recidiva/richiamo. Lo studio ha dimostrato un'efficacia straordinaria con un 96% di tasso di risposta complessiva e un 87% di tasso di risposta completa tra 111 pazienti dopo un follow-up mediano di due anni.

I risultati chiave includono un 80% di sopravvivenza libera da progressione a 21 mesi e un 90% di tasso di sopravvivenza complessiva a due anni. Il trattamento ha mostrato risposte durature con il 89% dei rispondenti completi che hanno mantenuto la loro risposta a 18 mesi. La FDA ha recentemente concessa la designazione di terapia innovativa per questa terapia combinata.

Eventi avversi notevoli includevano neutropenia (62%) e sindrome da rilascio di citochine (51%, principalmente di basso grado). Il COVID-19 ha colpito il 57% dei pazienti, portando a una sospensione del trattamento nel 13% dei casi, con cinque esiti fatali.

Genmab A/S (GMAB) anunció resultados prometedores del ensayo de fase 1b/2 EPCORE® NHL-2 que evalúa la terapia combinada con epcoritamab en pacientes con linfoma folicular en recaída/refractario. El estudio demostró una eficacia notable con un 96% de tasa de respuesta general y un 87% de tasa de respuesta completa entre 111 pacientes después de un seguimiento mediano de dos años.

Los resultados clave incluyen un 80% de supervivencia libre de progresión a 21 meses y un 90% de tasa de supervivencia general a dos años. El tratamiento mostró respuestas duraderas con el 89% de los que respondieron completamente manteniendo su respuesta a los 18 meses. La FDA recientemente otorgó la designación de terapia innovadora para esta terapia combinada.

Los efectos adversos notables incluyeron neutropenia (62%) y síndrome de liberación de citoquinas (51%, en su mayoría de bajo grado). El COVID-19 afectó al 57% de los pacientes, lo que llevó a la interrupción del tratamiento en el 13% de los casos, con cinco desenlaces fatales.

Genmab A/S (GMAB)는 재발/불응형 여포림프종 환자에서 epcoritamab 병용 요법을 평가한 Phase 1b/2 EPCORE® NHL-2 시험에서 유망한 결과를 발표했습니다. 연구 결과 111명의 환자에서 2년의 중간 추적 조사 후 96%의 전체 반응률87%의 완전 반응률로 뛰어난 효능을 보였습니다.

주요 결과로는 21개월 시점에서 80%의 무진행 생존율과 2년 동안 90%의 전체 생존율이 포함됩니다. 치료는 지속적인 반응을 보여주었으며, 완전 반응자의 89%가 18개월 동안 반응을 유지했습니다. FDA는 최근 이 병용 요법에 대해 혁신 치료제 지정(무조건 우선 심사)을 부여했습니다.

주목할 만한 부작용으로는 호중구감소증(62%)과 사이토카인 방출 증후군(51%, 대부분 경미한 정도)이 포함되었습니다. COVID-19는 환자의 57%에 영향을 미쳐 치료 중단이 13%의 경우에 발생했으며, 5명의 치명적 결과가 발생했습니다.

Genmab A/S (GMAB) a annoncé des résultats prometteurs de l'essai de phase 1b/2 EPCORE® NHL-2 évaluant la thérapie combinée avec l'épcoritamab chez des patients atteints de lymphome folliculaire en rechute/réfractaire. L'étude a démontré une efficacité remarquable avec un 96% de taux de réponse global et un 87% de taux de réponse complète parmi 111 patients après un suivi médian de deux ans.

Les résultats clés incluent un 80% de survie sans progression à 21 mois et un 90% de taux de survie global à deux ans. Le traitement a montré des réponses durables avec 89% des répondeurs complets maintenant leur réponse à 18 mois. La FDA a récemment accordé la désignation de thérapie innovante pour cette thérapie combinée.

Les événements indésirables notables comprenaient une neutropénie (62%) et un syndrome de libération de cytokines (51%, principalement de faible intensité). Le COVID-19 a touché 57% des patients, entraînant une interruption de traitement dans 13% des cas, avec cinq résultats fatals.

Genmab A/S (GMAB) hat vielversprechende Ergebnisse aus der Phase 1b/2 EPCORE® NHL-2-Studie bekannt gegeben, die die Kombinationstherapie mit Epcoritamab bei Patienten mit rezidiviertem/refraktärem follikulärem Lymphom bewertet. Die Studie zeigte eine bemerkenswerte Wirksamkeit mit einer 96%igen Gesamtansprechrate und einer 87%igen vollständigen Ansprechrate bei 111 Patienten nach einer medianen Nachbeobachtungszeit von zwei Jahren.

Zu den wichtigsten Ergebnissen gehören eine 80%ige progressionsfreie Überlebensrate nach 21 Monaten und eine 90%ige Gesamtüberlebensrate nach zwei Jahren. Die Behandlung zeigte anhaltende Antworten, wobei 89% der vollständigen Ansprechenden ihre Antwort nach 18 Monaten aufrechterhielten. Die FDA hat kürzlich dieser Kombinationstherapie den Status einer bahnbrechenden Therapie verliehen.

Bemerkenswerte unerwünschte Ereignisse umfassten Neutropenie (62%) und Zytokinfreisetzungssyndrom (51%, überwiegend niedriggradig). COVID-19 betraf 57% der Patienten, was zu einer Therapieunterbrechung in 13% der Fälle führte, mit fünf tödlichen Ausgängen.

Positive
  • 96% overall response rate and 87% complete response rate in Phase 1b/2 trial
  • 80% progression-free survival at 21 months
  • 90% two-year overall survival rate
  • 89% of complete responders maintained response at 18 months
  • FDA granted breakthrough therapy designation for the combination therapy
Negative
  • COVID-19 led to treatment discontinuation in 13% of patients
  • Five fatal COVID-19-related adverse events reported
  • High rate of adverse events: neutropenia (62%) and cytokine release syndrome (51%)

Insights

The clinical trial results for epcoritamab combination therapy show exceptional promise in treating relapsed/refractory follicular lymphoma. The 96% overall response rate and 87% complete response rate are remarkably high for this difficult-to-treat patient population. The durability of response is particularly impressive, with 80% progression-free survival at 21 months and 90% overall survival at two years.

The safety profile appears manageable, with cytokine release syndrome being mostly low-grade and manageable. While COVID-19 impacted the study significantly, the efficacy results remained strong. The recent FDA breakthrough therapy designation further validates the potential of this treatment approach.

This development represents a significant market opportunity for Genmab. The follicular lymphoma treatment market is substantial and these strong efficacy data position epcoritamab competitively in this space. The breakthrough therapy designation will accelerate the regulatory pathway, potentially leading to faster market access. The combination with established treatments (rituximab and lenalidomide) could facilitate market adoption and expand the commercial potential. The robust survival data and high response rates could support premium pricing upon approval.

COPENHAGEN, Denmark--(BUSINESS WIRE)-- Genmab A/S (Nasdaq: GMAB):

  • Results show 96 percent overall response rate (ORR), 87 percent complete response (CR), and 80 percent 21-month progression-free survival (PFS) in patients with relapsed or refractory (R/R) follicular lymphoma (FL) following treatment with epcoritamab plus lenalidomide + rituximab (R2)
  • Long-term follow-up results demonstrated strong and durable efficacy, with an estimated two-year overall survival (OS) rate of 90 percent
  • Results follow recent breakthrough therapy designation (BTD) granted by U.S. Food and Drug Administration (FDA) and support ongoing Phase 3 EPCORE® FL-1 trial evaluating epcoritamab + R2 in patients with R/R FL

Genmab A/S (Nasdaq: GMAB) today announced new results from the Phase 1b/2 EPCORE® NHL-2 trial evaluating fixed-duration epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, plus lenalidomide + rituximab (R2) in adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The results demonstrated an overall response rate (ORR) of 96 percent and a complete response (CR) rate of 87 percent among 111 patients after a median follow-up of two years. Additionally, the study showed an estimated 21-month progression-free survival (PFS) rate of 80 percent and a two-year overall survival (OS) rate of 90 percent. The data (Abstract #342) were shared today during an oral presentation at the 66th Annual Meeting and Exposition of the American Society of Hematology (ASH).

“Follicular lymphoma is incurable in most patients, and patients living with relapsed or refractory follicular lymphoma, particularly those with high-risk features, are in need of additional therapeutic options,” said Lorenzo Falchi, MD, Lymphoma Specialist, Department of Medicine, Memorial Sloan Kettering Cancer Center.i “The durable responses seen in the EPCORE NHL-2 trial are encouraging and support the ongoing investigation of epcoritamab in combination with the standard regimen of rituximab plus lenalidomide.”

Additional data from the study showed an estimated 89 percent of complete responders to the combination therapy remained in CR at 18 months (duration of CR; DoCR).

With the majority of patients being enrolled and treated during the global COVID-19 pandemic, COVID-19 was reported in 57 percent of patients and led to epcoritamab discontinuation in 13 percent of patients. Five cases of COVID-19 led to fatal treatment-emergent adverse events (TEAEs; COVID-19, n=3; COVID-19 pneumonia, n=2). The other most common TEAEs were neutropenia (62 percent) and cytokine release syndrome (CRS; 51 percent). CRS events with the 2-step step-up dose regimen were mostly low grade (38 percent Grade 1, 12 percent Grade 2, 2 percent Grade 3) and primarily occurred following the first full dose. All CRS cases resolved. One case of immune effector cell-associated neurotoxicity syndrome (ICANS) was reported (Grade 1). The CRS and ICANS cases did not lead to treatment discontinuation.

“The long-term results for epcoritamab combination therapy presented at ASH are very encouraging for patients facing the challenges of relapsed or refractory follicular lymphoma,” said Dr. Judith Klimovsky, Executive Vice President & Chief Development Officer, Genmab. “These data reinforce the potential of epcoritamab in follicular lymphoma across treatment lines and support our goal to develop epcoritamab as a potential core therapy for the treatment of B-cell malignancies, both as a monotherapy and with different combinations of standards of care across different lines of therapy and patient populations. We look forward to further evaluating this combination in the ongoing Phase 3 EPCORE FL-1 trial.”

The U.S. Food and Drug Administration (FDA) recently granted breakthrough therapy designation (BTD) for epcoritamab plus R2 for the treatment of adult patients with R/R FL who have received at least one prior line of therapy. Epcoritamab in combination with R2 is being studied further in the ongoing, randomized, Phase 3 EPCORE FL-1 trial (NCT05409066).

Use of epcoritamab + R2 in R/R FL is not approved in the U.S. or in the EU or in any other territory. The safety and efficacy of epcoritamab for use as a combination therapy in FL have not been established.

About Follicular Lymphoma (FL)

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.ii About 15,000 people develop FL each year in the U.S.iii and it is considered incurable with current standard of care therapies.iv Patients often relapse and, with each relapse the remission and time to next treatment is shorter.v Over time, transformation to diffuse large B-cell lymphoma (DLBCL), an aggressive form of NHL associated with poor survival outcomes, can occur in more than 25 percent of FL patients.vi

About the EPCORE® NHL-2 Trial

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. Arm 2 of the trial is epcoritamab + rituximab and lenalidomide (R2) in participants with relapsed/refractory (R/R) follicular lymphoma (FL). More information on this trial can be found at https://www.clinicaltrials.gov/ (NCT: 04663347).

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.vii

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. 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 lenalidomide 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) U.S. INDICATIONS & IMPORTANT SAFETY INFORMATION

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 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. For more information, please visit Genmab.com and follow us on LinkedIn and X.

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 U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®, HexElect® and KYSO™. EPCORE®, EPKINLY®, TEPKINLY® and their designs are trademarks of AbbVie Biotechnology Ltd.

i Dr. Falchi has financial interests related to Genmab and AbbVie.
ii Lymphoma Research Foundation official website. https://lymphoma.org/aboutlymphoma/nhl/fl/. Accessed November 2024.
iii Leukemia & Lymphoma Society. https://www.lls.org/research/follicular-lymphoma-fl. Accessed November 2024.
iv 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.
v 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.
vi 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.
vii 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.

David Freundel, Senior Director, Global R&D & Portfolio Communications

T: +1 609 430 2481; E: dafr@genmab.com

Andrew Carlsen, Vice President, Head of Investor Relations

T: +45 3377 9558; E: acn@genmab.com

Source: Genmab A/S

FAQ

What were the key efficacy results of the EPCORE NHL-2 trial for GMAB's epcoritamab?

The trial showed 96% overall response rate, 87% complete response rate, 80% progression-free survival at 21 months, and 90% two-year overall survival rate in relapsed/refractory follicular lymphoma patients.

What breakthrough designation did GMAB's epcoritamab receive from the FDA in 2023?

The FDA granted breakthrough therapy designation for epcoritamab plus lenalidomide and rituximab (R2) for treating adult patients with relapsed/refractory follicular lymphoma who have received at least one prior therapy.

What were the main safety concerns in GMAB's EPCORE NHL-2 trial?

The main safety concerns included neutropenia (62%), cytokine release syndrome (51%), and COVID-19 complications, which affected 57% of patients and led to treatment discontinuation in 13% of cases, including five fatal outcomes.

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