Investigational Epcoritamab (DuoBody ® CD3xCD20) Mixture Remedy Demonstrates Excessive Response Charges in Scientific Trial of Sufferers With Relapsed or Refractory (R/R) Follicular Lymphoma (FL)

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

• Outcomes present 96 p.c general response fee (ORR), 87 p.c full response (CR), and 80 p.c 21-month progression-free survival (PFS) in sufferers with relapsed or refractory (R/R) follicular lymphoma (FL) following therapy with epcoritamab plus lenalidomide + rituximab (R2)
• Lengthy-term follow-up outcomes demonstrated robust and sturdy efficacy, with an estimated two-year general survival (OS) fee of 90 p.c
• Outcomes comply with latest breakthrough remedy designation (BTD) granted by U.S. Meals and Drug Administration (FDA) and assist ongoing Section 3 EPCORE ® FL-1 trial evaluating epcoritamab + R2 in sufferers with R/R FL

Genmab (NASDAQ:) A/S (Nasdaq: GMAB) in the present day introduced new outcomes from the Section 1b/2 EPCORE ® NHL-2 trial evaluating fixed-duration epcoritamab, a T-cell participating bispecific antibody administered subcutaneously, plus lenalidomide + rituximab (R2) in grownup sufferers with relapsed or refractory (R/R) follicular lymphoma (FL). The outcomes demonstrated an general response fee (ORR) of 96 p.c and an entire response (CR) fee of 87 p.c amongst 111 sufferers after a median follow-up of two years. Moreover, the examine confirmed an estimated 21-month progression-free survival (PFS) fee of 80 p.c and a two-year general survival (OS) fee of 90 p.c. The information (Summary #342) had been shared in the present day throughout an oral presentation on the 66th Annual Assembly and Exposition of the American Society of Hematology (ASH).

Follicular lymphoma is incurable in most sufferers, and sufferers residing with relapsed or refractory follicular lymphoma, significantly these with high-risk options, are in want of extra therapeutic choices, stated Lorenzo Falchi, MD, Lymphoma Specialist, Division of Medication, Memorial Sloan Kettering Most cancers Heart.i The sturdy responses seen within the EPCORE NHL-2 trial are encouraging and assist the continuing investigation of epcoritamab together with the usual routine of rituximab plus lenalidomide.

Further information from the examine confirmed an estimated 89 p.c of full responders to the mixture remedy remained in CR at 18 months (length of CR; DoCR).

With the vast majority of sufferers being enrolled and handled in the course of the world COVID-19 pandemic, COVID-19 was reported in 57 p.c of sufferers and led to epcoritamab discontinuation in 13 p.c of sufferers. 5 circumstances of COVID-19 led to deadly treatment-emergent hostile occasions (TEAEs; COVID-19, n=3; COVID-19 pneumonia, n=2). The opposite most typical TEAEs had been neutropenia (62 p.c) and cytokine launch syndrome (CRS; 51 p.c). CRS occasions with the 2-step step-up dose routine had been largely low grade (38 p.c Grade 1, 12 p.c Grade 2, 2 p.c Grade 3) and primarily occurred following the primary full dose. All CRS circumstances resolved. One case of immune effector cell-associated neurotoxicity syndrome (ICANS) was reported (Grade 1). The CRS and ICANS circumstances didn’t result in therapy discontinuation.

The long-term outcomes for epcoritamab mixture remedy offered at ASH are very encouraging for sufferers dealing with the challenges of relapsed or refractory follicular lymphoma, stated Dr. Judith Klimovsky, Government Vice President & Chief Growth Officer, Genmab. These information reinforce the potential of epcoritamab in follicular lymphoma throughout therapy strains and assist our objective to develop epcoritamab as a possible core remedy for the therapy of B-cell malignancies, each as a monotherapy and with totally different mixtures of requirements of care throughout totally different strains of remedy and affected person populations. We stay up for additional evaluating this mixture within the ongoing Section 3 EPCORE FL-1 trial.

The U.S. Meals and Drug Administration (FDA) just lately granted breakthrough remedy designation (BTD) for epcoritamab plus R2 for the therapy of grownup sufferers with R/R FL who’ve obtained not less than one prior line of remedy. Epcoritamab together with R2 is being studied additional within the ongoing, randomized, Section 3 EPCORE FL-1 trial (NCT05409066).

Use of epcoritamab + R2 in R/R FL is just not authorised within the U.S. or within the EU or in another territory. The protection and efficacy of epcoritamab to be used as a mix remedy in FL haven’t been established.

About Follicular Lymphoma (FL)

FL is usually an indolent (or slow-growing) type of non-Hodgkin’s lymphoma (NHL) that arises from B-lymphocytes and is the second most typical type of NHL accounting for 20-30 p.c of all circumstances.ii About 15,000 folks develop FL every year in the united statesiii and it’s thought of incurable with present customary of care therapies.iv Sufferers typically relapse and, with every relapse the remission and time to subsequent therapy is shorter.v Over time, transformation to diffuse giant B-cell lymphoma (DLBCL), an aggressive type of NHL related to poor survival outcomes, can happen in additional than 25 p.c of FL sufferers.vi

In regards to the EPCORE ® NHL-2 Trial

EPCORE ® NHL-2 is a Section 1b/2 open-label interventional trial to guage the security, tolerability, pharmacokinetics, pharmacodynamics/biomarkers, immunogenicity, and preliminary efficacy of epcoritamab as a monotherapy and together with different customary of care brokers in sufferers with B-cell non-Hodgkin’s lymphoma (B-NHL). The trial consists of two elements: Half 1 (Dose Escalation) and Half 2 (Dose Enlargement). The first goal of Half 1 is security, and the first objective of Half 2 is preliminary efficacy. Arm 2 of the trial is epcoritamab + rituximab and lenalidomide (R2) in individuals with relapsed/refractory (R/R) follicular lymphoma (FL). Extra info on this trial could be discovered at https://www.clinicaltrials.gov/ (NCT: 04663347).

About Epcoritamab

Epcoritamab is an IgG1-bispecific antibody created utilizing Genmab’s proprietary DuoBody ® expertise and administered subcutaneously. Genmab’s DuoBody-CD3 expertise is designed to direct cytotoxic T cells selectively to elicit an immune response towards goal cell varieties. Epcoritamab is designed to concurrently bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.vii

Epcoritamab (authorised beneath the model identify EPKINLY ® within the U.S. and Japan, and TEPKINLY ® within the EU) has obtained regulatory approval in sure lymphoma indications in a number of territories. Epcoritamab is being co-developed by Genmab and AbbVie (NYSE:) as a part of the businesses’ oncology collaboration. The businesses will share industrial obligations within the U.S. and Japan, with AbbVie liable for additional world commercialization. Each firms will pursue extra worldwide regulatory approvals for the investigational R/R FL indication and extra approvals for the R/R DLBCL indication.

Genmab and AbbVie proceed to guage using epcoritamab as a monotherapy, and together, throughout strains of remedy in a variety of hematologic malignancies. This contains 5 ongoing Section 3, open-label, randomized trials together with a trial evaluating epcoritamab as a monotherapy in sufferers with R/R DLBCL in comparison with investigators selection chemotherapy (NCT04628494), a trial evaluating epcoritamab together with R-CHOP in grownup sufferers with newly recognized DLBCL (NCT05578976), a trial evaluating epcoritamab together with rituximab and lenalidomide (R2) in sufferers with R/R FL (NCT05409066), a trial evaluating epcoritamab together with rituximab and lenalidomide (R2) in comparison with chemoimmunotherapy in sufferers with beforehand untreated FL (NCT06191744), and a trial evaluating epcoritamab together with lenalidomide in comparison with chemotherapy infusion in sufferers with R/R DLBCL (NCT06508658). The protection and efficacy of epcoritamab has not been established for these investigational makes use of. Please go to www.clinicaltrials.gov for extra info.

EPKINLY ® (epcoritamab-bysp) U.S. INDICATIONS & IMPORTANT SAFETY INFORMATION

What’s EPKINLY?

EPKINLY is a prescription drugs used to deal with adults with sure varieties of diffuse giant B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, or follicular lymphoma (FL) that has come again or that didn’t reply to earlier therapy after receiving 2 or extra remedies. EPKINLY is authorised primarily based on affected person response information. Research are ongoing to verify the medical good thing about EPKINLY. It isn’t identified if EPKINLY is protected and efficient in youngsters.

Necessary Warnings”EPKINLY could cause severe unwanted side effects, together with:

• Cytokine launch syndrome (CRS), which is widespread throughout therapy with EPKINLY and could be severe or life-threatening. To assist cut back your threat of CRS, you’ll obtain EPKINLY on a step-up dosing schedule (if you obtain 2 or 3 smaller step-up doses of EPKINLY earlier than your first full dose throughout your first cycle of therapy), and you might also obtain different medicines earlier than and for 3 days after receiving EPKINLY. In case your dose of EPKINLY is delayed for any motive, you might have to repeat the step-up dosing schedule.
• Neurologic issues that may be life-threatening and result in demise. Neurologic issues might occur days or perhaps weeks after you obtain EPKINLY.

Individuals with DLBCL or high-grade B-cell lymphoma must be hospitalized for twenty-four hours after receiving their first full dose of EPKINLY on day 15 of cycle 1 because of the threat of CRS and neurologic issues.

Inform (WA:) your healthcare supplier or get medical assist straight away for those who develop a fever of 100.4 °F (38 °C) or greater; dizziness or lightheadedness; bother respiration; chills; quick heartbeat; feeling anxious; headache; confusion; shaking (tremors); issues with stability and motion, reminiscent of bother strolling; bother talking or writing; confusion and disorientation; drowsiness, tiredness or lack of power; muscle weak point; seizures; or reminiscence loss. These could also be signs of CRS or neurologic issues. You probably have any signs that impair consciousness, don’t drive or use heavy equipment or do different harmful actions till your signs go away.

EPKINLY could cause different severe unwanted side effects, together with:

• Infections that will result in demise. Your healthcare supplier will verify you for indicators and signs of an infection earlier than and through therapy and deal with you as wanted for those who develop an an infection. It’s best to obtain medicines out of your healthcare supplier earlier than you begin therapy to assist forestall an infection. Inform your healthcare supplier straight away for those who develop any signs of an infection throughout therapy, together with fever of 100.4 °F (38 °C) or greater, cough, chest ache, tiredness, shortness of breath, painful rash, sore throat, ache throughout urination, or feeling weak or typically unwell.
• Low blood cell counts, which could be severe or extreme. Your healthcare supplier will verify your blood cell counts throughout therapy. EPKINLY might trigger low blood cell counts, together with low white blood cells (neutropenia), which might improve your threat for an infection; low crimson blood cells (anemia), which might trigger tiredness and shortness of breath; and low platelets (thrombocytopenia), which might trigger bruising or bleeding issues.

Your healthcare supplier will monitor you for signs of CRS, neurologic issues, infections, and low blood cell counts throughout therapy with EPKINLY. Your healthcare supplier might briefly cease or fully cease therapy with EPKINLY for those who develop sure unwanted side effects.

Earlier than you obtain EPKINLY, inform your healthcare supplier about all of your medical situations, together with for those who have an an infection, are pregnant or plan to change into pregnant, or are breastfeeding or plan to breastfeed. In the event you obtain EPKINLY whereas pregnant, it could hurt your unborn child. If you’re a feminine who can change into pregnant, your healthcare supplier ought to do a being pregnant take a look at earlier than you begin therapy with EPKINLY and it is best to use efficient contraception (contraception) throughout therapy and for 4 months after your final dose of EPKINLY. Inform your healthcare supplier for those who change into pregnant or suppose that you could be be pregnant throughout therapy with EPKINLY. Don’t breastfeed throughout therapy with EPKINLY and for 4 months after your final dose of EPKINLY.

In DLBCL or high-grade B-cell lymphoma, the commonest unwanted side effects of EPKINLY embrace CRS, tiredness, muscle and bone ache, injection website reactions, fever, stomach-area (stomach) ache, nausea, and diarrhea. The commonest extreme irregular laboratory take a look at outcomes embrace decreased white blood cells, decreased crimson blood cells, and decreased platelets.

In follicular lymphoma the commonest unwanted side effects of EPKINLY embrace injection website reactions, CRS, COVID-19, tiredness, higher respiratory tract infections, muscle and bone ache, rash, diarrhea, fever, cough, and headache. The commonest extreme irregular laboratory take a look at outcomes embrace decreased white blood cells and decreased crimson blood cells.

These should not all the attainable unwanted side effects of EPKINLY. Name your physician for medical recommendation about unwanted side effects. You’re inspired to report unwanted 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 Info and Medicine Information, together with Necessary Warnings.

Globally, prescribing info varies; discuss with the person nation product label for full info.

About Genmab

Genmab is a global biotechnology firm with a core objective of guiding its unstoppable staff to attempt towards bettering the lives of sufferers with revolutionary and differentiated antibody therapeutics. For 25 years, its passionate, revolutionary and collaborative staff has invented next-generation antibody expertise platforms and leveraged translational, quantitative and information sciences, leading to a proprietary pipeline together with bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s imaginative and prescient is to rework the lives of individuals with most cancers and different severe ailments with knock-your-socks-off (KYSO ®) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with worldwide presence throughout North America, Europe and Asia Pacific. For extra info, please go to Genmab.com and comply with us on LinkedIn and X.

This Media Launch accommodates ahead trying statements. The phrases consider, anticipate, anticipate, intend and plan and comparable expressions determine ahead trying statements. Precise outcomes or efficiency might differ materially from any future outcomes or efficiency expressed or implied by such statements. The essential elements that would trigger our precise outcomes or efficiency to vary materially embrace, amongst others, dangers related to preclinical and medical improvement of merchandise, uncertainties associated to the result and conduct of medical trials together with unexpected questions of safety, uncertainties associated to product manufacturing, the dearth of market acceptance of our merchandise, our incapability to handle progress, the aggressive setting in relation to our enterprise space and markets, our incapability to draw and retain suitably certified personnel, the unenforceability or lack of safety of our patents and proprietary rights, {our relationships} with affiliated entities, modifications and developments in expertise which can render our merchandise or applied sciences out of date, and different elements. For an additional dialogue of those dangers, please discuss with the chance administration sections in Genmab’s most up-to-date monetary stories, which can be found on www.genmab.com and the chance elements included in Genmab’s most up-to-date Annual Report on Type 20-F and different filings with the U.S. Securities and Alternate Fee (SEC), which can be found at www.sec.gov. Genmab doesn’t undertake any obligation to replace or revise ahead trying statements on this Media Launch nor to verify such statements to replicate subsequent occasions or circumstances after the date made or in relation to precise outcomes, until required by legislation.

Genmab A/S and/or its subsidiaries personal the next logos: Genmab ®; the Y-shaped Genmab emblem ®; Genmab together with the Y-shaped Genmab emblem ®; HuMax ®; DuoBody ®; HexaBody ®; DuoHexaBody ®, HexElect ® and KYSO™. EPCORE ®, EPKINLY ®, TEPKINLY ® and their designs are logos of AbbVie Biotechnology Ltd.

i Dr. Falchi has monetary pursuits associated to Genmab and AbbVie.
ii Lymphoma Analysis Basis official web site. https://lymphoma.org/aboutlymphoma/nhl/fl/. Accessed November 2024.
iii Leukemia & Lymphoma Society. https://www.lls.org/analysis/follicular-lymphoma-fl. Accessed November 2024.
iv Ghione P, Palomba ML, Ghesquieres H, et al. Remedy patterns and outcomes in relapsed/refractory follicular lymphoma: outcomes from the worldwide SCHOLAR-5 examine. Haematologica. 2023;108(3):822-832. doi: 10.3324/haematol.2022.281421.
v Rivas-Delgado A, Magnano L, Moreno-Velázquez M, et al. Response length and survival shorten after every relapse in sufferers with follicular lymphoma handled within the rituximab period. Br J Haematol. 2018;184(5):753-759. doi:10.1111/bjh.15708.
vi Al-Tourah AJ, Gill KK, Chhanabhai M, et al. Inhabitants-based evaluation of incidence and end result of reworked 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 Fashions and Supplies Alternatives for Subcutaneous Dosing. EBioMedicine. 2020;52:102625. doi: 10.1016/j.ebiom.2019.102625.

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