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

• Knowledge offered on the 66^th Annual Assembly and Exposition of the American Society of Hematology (ASH)

NORTH CHICAGO, Ailing., Dec. 7, 2024 /PRNewswire/ — AbbVie (NYSE: NYSE:) at present introduced up to date outcomes from the Part 1b/2 EPCORE ^® NHL-2 trial evaluating fixed-duration investigational epcoritamab, a CD3xCD20 bispecific T-cell-engaging antibody administered subcutaneously, plus lenalidomide + rituximab (R²) in grownup sufferers with relapsed or refractory (R/R) follicular lymphoma (FL). Amongst 111 sufferers with a median follow-up of over two years, total response price (ORR) was 96%, and full response (CR) price was 87%. The information (Summary #342)¹ had been shared at present throughout an oral presentation on the 66^th Annual Assembly and Exposition of the American Society of Hematology (ASH).

“These knowledge spotlight the potential advantages of epcoritamab in treating sufferers with relapsed or refractory follicular lymphoma. Furthermore, they present that epcoritamab together with the generally used remedy of lenalidomide with rituximab (R²) might provide a doubtlessly sturdy and sturdy remedy choice,” stated Mariana Cota Stirner, M.D., Ph.D., vp, therapeutic space head for hematology, AbbVie. “These knowledge are very encouraging as we proceed to additional consider the potential of epcoritamab together with R² in an ongoing pivotal Part 3 trial and additional set up epcoritamab as a core remedy for the remedy of B-cell malignancies.”

FL is often an indolent (or slow-growing) type of non-Hodgkin’s lymphoma (NHL) that arises from B-lymphocytes and is the second commonest type of NHL accounting for 20-30% of all circumstances.^2,3 About 15,000 individuals develop FL annually within the U.S.⁴ and it’s thought-about incurable with present commonplace of care therapies.⁵ Sufferers typically relapse and, with every relapse the remission and time to subsequent remedy is shorter.⁶ Over time, transformation to diffuse massive B-cell lymphoma (DLBCL), an aggressive type of NHL related to poor survival outcomes, can happen in additional than 25% of FL sufferers.⁷

“As a result of follicular lymphoma is incurable, sufferers with relapsed or refractory follicular lymphoma want extra therapeutic choices,” stated Lorenzo Falchi, M.D., Lymphoma Specialist, Division of Medication, Memorial Sloan Kettering Most cancers Heart. “The sturdy responses seen within the EPCORE NHL-2 trial assist the continuing investigation of epcoritamab together with the usual routine of rituximab plus lenalidomide.”

Overview of Part 1b/2 EPCORE ^® NHL-2 Knowledge Outcomes:

• This examine’s major endpoint was ORR per Lugano standards, and grownup sufferers with R/R FL obtained subcutaneous epcoritamab + R² for as much as 12 cycles, adopted by 12 extra cycles of epcoritamab monotherapy (28 days every cycle). Amongst 111 sufferers with a median follow-up of over two years, the ORR was 96%, and the CR price was 87%. At 18 months an estimated 89% of full responders to the mix remedy remained in CR (period of CR; DoCR), 41 sufferers accomplished remedy per protocol. Minimal residual illness (MRD) evaluation from blood samples confirmed that 88% of sufferers had been MRD destructive, indicating no detectable illness at 10^-6 threshold.⁸
• COVID-19 was reported in 57% of sufferers and led to epcoritamab discontinuation in 13% of sufferers. 5 circumstances of COVID-19 led to deadly treatment-emergent antagonistic occasions (TEAEs; COVID-19, n=3; COVID-19 pneumonia, n=2). The opposite commonest TEAEs had been neutropenia (62%) and cytokine launch syndrome (CRS; 51%). CRS occasions with the 2-step step-up dose routine had been principally low grade (38% Grade 1, 12% Grade 2, 2% 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 remedy discontinuation.

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

Current Breakthrough Remedy Designation for Epcoritamab:

• The U.S. Meals and Drug Administration (FDA) just lately granted a breakthrough remedy designation (BTD) for epcoritamab plus R² for the remedy of grownup sufferers with R/R FL who’ve obtained a minimum of one prior line of remedy. Epcoritamab together with R² is being studied additional within the ongoing, randomized, Part 3 EPCORE FL-1 trial (NCT05409066).

Concerning the EPCORE ^® NHL-2 Trial
EPCORE ^® NHL-2 is a Part 1b/2 open-label interventional trial to judge the protection, tolerability, pharmacokinetics, pharmacodynamics/biomarkers, immunogenicity, and preliminary efficacy of epcoritamab as a monotherapy and together with different commonplace of care brokers in sufferers with B-cell non-Hodgkin’s lymphoma (B-NHL). The trial consists of two components: Half 1 (Dose Escalation) and Half 2 (Dose Enlargement). The first goal of Half 1 is security, and it consists of Arm 1-5 and Arm 10. Half 2 consists of all 10 arms (Arm 1-10) and the first objective of all arms, besides Arm 7, is preliminary efficacy. Arm 2 of the trial is epcoritamab + rituximab and lenalidomide (R²) in contributors with relapsed/refractory (R/R) follicular lymphoma (FL). Extra info on this trial may be discovered at https://www.clinicaltrials.gov/ (NCT: 04663347). The first endpoint was total response price (ORR) primarily based on finest total response per Lugano standards. MRD negativity was assessed as a secondary endpoint.

Concerning the EPCORE ^® FL-1 Trial
EPCORE ^® FL-1 is a Part 3 open-label interventional trial to judge the protection and efficacy of epcoritamab + rituximab and lenalidomide (R²) versus R² alone in sufferers with relapsed/refractory (R/R) follicular lymphoma (FL). The first endpoint is progression-free survival (PFS) assessed by impartial overview committee (IRC) per Lugano standards. Extra endpoints embody share of contributors reaching full response (CR), total survival (OS) and share of sufferers reaching minimal residual illness (MRD) negativity. Extra info on this trial may be discovered at https://www.clinicaltrials.gov/ (NCT: 05409066).

About Epcoritamab
Epcoritamab is an IgG1-bispecific antibody created utilizing Genmab (NASDAQ:)’s proprietary DuoBody ^® know-how and administered subcutaneously. Genmab’s DuoBody-CD3 know-how 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.⁹ Epcoritamab (authorized underneath the model title 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 as a part of the businesses’ oncology collaboration. The businesses share industrial duties within the U.S. and Japan, with AbbVie liable for additional international commercialization. Each corporations 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 judge using epcoritamab as a monotherapy, and together, throughout traces of remedy in a spread of hematologic malignancies. This consists of 5 ongoing Part 3, open-label, randomized trials together with a trial evaluating epcoritamab as a monotherapy in sufferers with R/R DLBCL in comparison with investigators alternative 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) INDICATIONS & U.S. IMPORTANT SAFETY INFORMATION

What’s EPKINLY?
EPKINLY is a prescription medication used to deal with adults with sure sorts of diffuse massive B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, or follicular lymphoma (FL) that has come again or that didn’t reply to earlier remedy after receiving 2 or extra therapies. EPKINLY is authorized primarily based on affected person response knowledge. Research are ongoing to substantiate the scientific advantage of EPKINLY. It’s not recognized if EPKINLY is secure and efficient in youngsters.

Essential Warnings”EPKINLY may cause severe negative effects, together with:

• Cytokine launch syndrome (CRS), which is widespread throughout remedy with EPKINLY and may be severe or life-threatening. To assist cut back your danger of CRS, you’ll obtain EPKINLY on a step-up dosing schedule (once you obtain 2 or 3 smaller step-up doses of EPKINLY earlier than your first full dose throughout your first cycle of remedy), and you may additionally obtain different medicines earlier than and for 3 days after receiving EPKINLY. In case your dose of EPKINLY is delayed for any cause, 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.

Folks with DLBCL or high-grade B-cell lymphoma ought to be hospitalized for twenty-four hours after receiving their first full dose of EPKINLY on day 15 of cycle 1 as a result of danger of CRS and neurologic issues.

Inform (WA:) your healthcare supplier or get medical assist straight away if you happen to develop a fever of 100.4 °F (38 °C) or greater; dizziness or lightheadedness; hassle respiration; chills; quick heartbeat; feeling anxious; headache; confusion; shaking (tremors); issues with steadiness and motion, reminiscent of hassle strolling; hassle 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. When you’ve got any signs that impair consciousness, don’t drive or use heavy equipment or do different harmful actions till your signs go away.

EPKINLY may cause different severe negative effects, together with:

• Infections which will result in demise. Your healthcare supplier will test you for indicators and signs of an infection earlier than and through remedy and deal with you as wanted if you happen to develop an an infection. It is best to obtain medicines out of your healthcare supplier earlier than you begin remedy to assist forestall an infection. Inform your healthcare supplier straight away if you happen to develop any signs of an infection throughout remedy, 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 usually unwell.
• Low blood cell counts, which may be severe or extreme. Your healthcare supplier will test your blood cell counts throughout remedy. EPKINLY might trigger low blood cell counts, together with low white blood cells (neutropenia), which might improve your danger 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 remedy with EPKINLY. Your healthcare supplier might quickly cease or utterly cease remedy with EPKINLY if you happen to develop sure negative effects.

Earlier than you obtain EPKINLY, inform your healthcare supplier about all of your medical circumstances, together with if you happen to have an an infection, are pregnant or plan to develop into pregnant, or are breastfeeding or plan to breastfeed. When you obtain EPKINLY whereas pregnant, it could hurt your unborn child. In case you are a feminine who can develop into pregnant, your healthcare supplier ought to do a being pregnant check earlier than you begin remedy with EPKINLY and you must use efficient contraception (contraception) throughout remedy and for 4 months after your final dose of EPKINLY. Inform your healthcare supplier if you happen to develop into pregnant or assume that you could be be pregnant throughout remedy with EPKINLY. Don’t breastfeed throughout remedy with EPKINLY and for 4 months after your final dose of EPKINLY.

In DLBCL or high-grade B-cell lymphoma, the commonest negative effects of EPKINLY embody CRS, tiredness, muscle and bone ache, injection website reactions, fever, stomach-area (belly) ache, nausea, and diarrhea. The commonest extreme irregular laboratory check outcomes embody decreased white blood cells, decreased crimson blood cells, and decreased platelets.

In follicular lymphoma the commonest negative effects of EPKINLY embody 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 check outcomes embody decreased white blood cells and decreased crimson blood cells.

These should not all the doable negative effects of EPKINLY. Name your physician for medical recommendation about negative effects. You might be inspired to report negative 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 Data and Medicine Information, together with Essential Warnings.

About AbbVie in Oncology
At AbbVie, we’re dedicated to remodeling requirements of take care of a number of blood cancers whereas advancing a dynamic pipeline of investigational therapies throughout a spread of most cancers varieties. Our devoted and skilled crew joins forces with progressive companions to speed up the supply of potential breakthrough medicines. We’re evaluating greater than 20 investigational medicines in over 300 scientific trials throughout among the world’s most widespread and debilitating cancers. As we work to have a outstanding influence on individuals’s lives, we’re dedicated to exploring options to assist sufferers get hold of entry to our most cancers medicines. For extra info, please go to http://www.abbvie.com/oncology.

About AbbVie
AbbVie‘s mission is to find and ship progressive medicines and options that clear up severe well being points at present and deal with the medical challenges of tomorrow. We attempt to have a outstanding influence on individuals’s lives throughout a number of key therapeutic areas “ immunology, oncology, neuroscience, and eye care “ and services in our Allergan (NYSE:) Aesthetics portfolio. For extra details about AbbVie, please go to us at www.abbvie.com. Observe @abbvie on LinkedIn, Fb (NASDAQ:), Instagram, X (previously Twitter), and YouTube.

AbbVie Ahead-Wanting Statements
Some statements on this information launch are, or could also be thought-about, forward-looking statements for functions of the Personal Securities Litigation Reform Act of 1995. The phrases “consider,” “anticipate,” “anticipate,” “mission” and related expressions and makes use of of future or conditional verbs, usually establish forward-looking statements. AbbVie cautions that these forward-looking statements are topic to dangers and uncertainties which will trigger precise outcomes to vary materially from these expressed or implied within the forward-looking statements. Such dangers and uncertainties embody, however should not restricted to, challenges to mental property, competitors from different merchandise, difficulties inherent within the analysis and improvement course of, antagonistic litigation or authorities motion, and adjustments to legal guidelines and laws relevant to our business. Extra details about the financial, aggressive, governmental, technological and different components which will have an effect on AbbVie‘s operations is ready forth in Merchandise 1A, “Danger Components,” of AbbVie‘s 2023 Annual Report on Kind 10-Ok, which has been filed with the Securities and Alternate Fee, as up to date by its subsequent Quarterly Studies on Kind 10-Q. AbbVie undertakes no obligation, and particularly declines, to launch publicly any revisions to forward-looking statements on account of subsequent occasions or developments, besides as required by regulation.

Disclosure: Dr. Falchi has monetary pursuits associated to AbbVie and Genmab.

¹Falchi, et al. Mounted-Length Epcoritamab + R² Drives Deep and Sturdy Responses in Sufferers with Relapsed or Refractory Follicular Lymphoma: 2-12 months Observe-up from Arm 2 of the Epcore NHL-2 Trial. Summary retrieved from ASH Annual Assembly & Exposition Database. 2024.
²Lymphoma Analysis Basis official web site. https://lymphoma.org/aboutlymphoma/nhl/fl/. Accessed November 2024.
³Leukemia & Lymphoma Society official web site. https://www.lls.org/lymphoma/non-hodgkin-lymphoma/nhl-subtypes. Accessed December 2024.
⁴Leukemia & Lymphoma Society. https://www.lls.org/analysis/follicular-lymphoma-fl. Accessed November 2024.
⁵Ghione P, Palomba ML, Ghesquieres H, et al. Therapy 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.
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⁹Engelberts 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.