{"success":true,"data":{"pressRelease":{"id":"160941","rtpr_id":"nBw6htZ3Ja-20261005","ticker":"ABBV","exchange":"NYSE","all_tickers":["ABBV","GMAB"],"title":"Genmab and AbbVie Announce Epcoritamab in Combination with R-CHOP Demonstrates Statistically Significant Improvement in Progression-Free Survival in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma","author":"Business Wire","published_at":"2026-10-05T18:50:00.104Z","article_body":"Genmab and AbbVie Announce Epcoritamab in Combination with R-CHOP Demonstrates\nStatistically Significant Improvement in Progression-Free Survival in Patients\nwith Newly Diagnosed Diffuse Large B-Cell Lymphoma\n\n\n * EPCORE DLBCL-2 is the first Phase 3 study of a bispecific antibody combination\ntherapy to demonstrate statistically significant and clinically meaningful\nimprovement in progression-free survival (PFS) in frontline diagnosed diffuse\nlarge B-cell lymphoma (DLBCL) patients\n\n * Based on the topline results, Genmab and AbbVie will engage global regulatory\nauthorities\n\nGenmab A/S\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.genmab.com&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=Genmab+A%2FS&index=1&md5=19471c08d31b51e45c1f4c2155fe5539)\n(Nasdaq: GMAB) and AbbVie (NYSE: ABBV) announced today positive topline\nresults from the Phase 3 EPCORE DLBCL-2 trial evaluating fixed treatment\nduration epcoritamab, a T-cell engaging bispecific antibody administered\nsubcutaneously, in combination with standard of care rituximab,\ncyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone\n(R-CHOP), compared to R-CHOP alone, in newly diagnosed patients with diffuse\nlarge B-cell lymphoma (DLBCL) with an International Prognostic Index (IPI)\nscore of 2 to 5. The trial demonstrated a statistically significant and\nclinically meaningful improvement in progression-free survival (PFS) in DLBCL\npatients with an IPI score of 2 to 5. The risk of disease progression or death\nwas reduced by 51% (HR 0.49 [95% CI 0.36, 0.67]; p-value < 0.0001). The\nsafety profile of epcoritamab when administered in combination with standard\nof care R-CHOP was generally well tolerated and consistent with the previously\nreported safety profiles of the individual agents (epcoritamab and R-CHOP).\n\n“These topline results of epcoritamab in combination with R-CHOP mark the\nfirst Phase 3 study to demonstrate a statistically significant improvement in\nprogression-free survival in patients with newly diagnosed DLBCL treated with\na bispecific antibody combination and have the potential to reshape the\nfrontline treatment landscape,” said Jan van de Winkel, Ph.D., Chief\nExecutive Officer of Genmab. “While treatment advances have improved\noutcomes for patients with diffuse large B-cell lymphoma, options for newly\ndiagnosed patients remain limited, reinforcing the need for additional\ntherapies that can treat as many patients as possible in the frontline\nsetting.”\n\n“DLBCL is an aggressive disease and the need to advance treatment options is\ncritical. These positive topline results suggest that epcoritamab combined\nwith R-CHOP could offer a potential new standard of care in newly diagnosed\nDLBCL patients,” said Daejin Abidoye, MD, vice president, therapeutic area\nhead, oncology, solid tumor and hematology, AbbVie. “The findings further\nstrengthen our understanding and potential of bispecifics across the lymphoma\ntreatment landscape, as we work to address urgent needs in this patient\npopulation.”\n\n\"As an investigator with firsthand experience in both the landmark trial that\nestablished R-CHOP as a standard of care nearly 25 years ago and EPCORE\nDLBCL-2, it is particularly meaningful to see the potential benefit of\nbispecific antibody therapy in newly diagnosed diffuse large B-cell\nlymphoma,” said Gilles Salles, MD, PhD, Chief of the Lymphoma Service and\nholder of the Steven A. Greenberg Chair at Memorial Sloan Kettering Cancer\nCenter. “The 51% reduction in the risk of progression or death is clinically\nmeaningful and highly relevant to everyday practice. These results have the\npotential to be practice-changing and could mark an important step forward in\nbringing the opportunity of cure to more patients.”\n\nData will be submitted for presentation at a future medical meeting. Genmab\nand AbbVie will engage global regulatory authorities to determine next steps.\nEpcoritamab plus R-CHOP is an investigational combination not approved by\nregulatory authorities.\n\nAbout the EPCORE(®) DLBCL-2 Trial\n\nEPCORE DLBCL-2 (NCT05578976\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fnam12.safelinks.protection.outlook.com%2F%3Furl%3Dhttps%253A%252F%252Fclinicaltrials.gov%252Fstudy%252FNCT05578976%26data%3D05%257C02%257Cmatt.skryja%2540abbvie.com%257C0543693c4438400461cc08df1fea3a40%257C6f4d03de95514ba1a25bdce6f5ab7ace%257C0%257C0%257C639264763066608281%257CUnknown%257CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%253D%253D%257C0%257C%257C%257C%26sdata%3DzZw6Pcu7AUQRTqIKncfU03s8x6QxbNuQg7%252BOQ9lWHT8%253D%26reserved%3D0&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=NCT05578976&index=2&md5=694bceea6b0e81ca1ff9fbd6787ba1aa)\n) is a global Phase 3 open label, multi-center, randomized trial to evaluate\nthe efficacy of fixed duration, subcutaneous epcoritamab (GEN3013,\nDuoBody(®)-CD3xCD20) and standard of care rituximab, cyclophosphamide,\ndoxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) compared to\nR-CHOP alone in patients with newly diagnosed large B-cell lymphoma (DLBCL).\nThe trial enrolled subjects with an International Prognostic Index (IPI) score\nof 2 to 5, including patients with diffuse large B-cell lymphoma, not\notherwise specified (DLBCL, NOS), high-grade B-Cell lymphoma (HGBL) with MYC\nand BCL2 and/or BCL6 rearrangements, follicular lymphoma grade 3B (FL3B),\nT-cell/histiocyte-rich large B-Cell lymphoma (TCHR LBLC), and Epstein-Barr\nVirus-positive diffuse large B-cell lymphoma (EBV+ DLBCL). The primary\nendpoint is PFS in participants with an International Prognostic Index (IPI)\nof 3-5 and the key secondary endpoint is PFS in total participants (IPI score\nof 2-5). The risk of disease progression or death for the primary endpoint\npopulation was reduced by 51% (HR 0.49 [95% CI 0.35, 0.69]; p-value <\n0.0001). Patients were randomized 2:1 to receive a fixed-duration regimen of\nepcoritamab plus R-CHOP for six cycles followed by epcoritamab alone for two\ncycles, or R-CHOP for six cycles followed by rituximab for two cycles. The\ntrial started on February 8, 2023, and is ongoing.\n\nMore information on this trial can be found at\nhttps://clinicaltrials.gov/study/NCT05578976\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT05578976&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT05578976&index=3&md5=d03ad7cf44f19918d263128883734d8b)\n(NCT: NCT05578976).\n\nAbout Diffuse Large B-Cell Lymphoma\n\nDiffuse large B-cell lymphoma (DLBCL) DLBCL is the most common type of\nnon-Hodgkin lymphoma (NHL) worldwide, accounting for approximately 25-30\npercent of all NHL cases.(i,ii) In the U.S., there are approximately 25,000\nnew cases of DLBCL diagnosed each year.(iii) DLBCL can arise in lymph nodes as\nwell as in organs outside of the lymphatic system, occurs more commonly in the\nelderly and is slightly more prevalent in men.(iv,v) DLBCL is a fast-growing\ntype of NHL, a cancer that develops in the lymphatic system and affects B-cell\nlymphocytes, a type of white blood cell. For many people living with DLBCL,\ntheir cancer either relapses, which means it may return after treatment, or\nbecomes refractory, meaning it does not respond to treatment. Although new\ntherapies have become available, treatment management can remain a\nchallenge.(iv,vi)\n\nAbout Epcoritamab\n\nEpcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary\nDuoBody technology and administered subcutaneously. Genmab's DuoBody-CD3\ntechnology is designed to direct cytotoxic T cells selectively to elicit an\nimmune response toward target cell types. Epcoritamab is designed to\nsimultaneously bind to CD3 on T cells and CD20 on B cells and induces\nT-cell-mediated killing of CD20+ cells.(vii)\n\nEpcoritamab (approved under the brand name EPKINLY(®) in the U.S. and Japan,\nand TEPKINLY(®) in the EU) has received regulatory approval in certain\nlymphoma indications in more than 65 countries. Where approved, epcoritamab is\na readily accessible therapy. Epcoritamab is being co-developed by Genmab and\nAbbVie as part of the companies' oncology collaboration. The companies share\ncommercial responsibilities in the U.S. and Japan, with AbbVie responsible for\nfurther global commercialization. Both companies will pursue additional\ninternational regulatory approvals for the relapsed or refractory (R/R)\nfollicular lymphoma (FL) indication and additional approvals for the R/R\ndiffuse large B-cell lymphoma (DLBCL) indication.\n\nGenmab and AbbVie continue to evaluate the use of epcoritamab as a\nmonotherapy, and in combination, across lines of therapy in a range of\nhematologic malignancies. This includes a trial evaluating epcoritamab in\ncombination with lenalidomide and rituximab (R(2)) compared to\nchemoimmunotherapy in patients with previously untreated FL (NCT06191744\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DRx84t76qIlVSOQSq3AC0Avc1qtLHERYiz7MuDCb1vhFIu7yT1MhlmYfH8uZAIzhDOROYWIyoXmUrmzcavhj5Qa_9W9P4yZkg2MWmNmiVlnnW_eNXiRShDP33e9AmiUAyTBjYnsgAXCRdLKfvYlCEBfGTMce6y3oM1tPFtp51PKtkj4BASginJgAPzbZcKEaoc8gXl4xpmgzfzuU1NcHL6xV8ptBO_DrK3HIMXJwiqOYJJJzkwFNOO9oOEiOBRJTJJXtXHhnoA44hl_WXYX3S3k90F92SURGhTOdoujS6935KPV_liUHiuTkyv-CxkzP2m95EDd-BB2il14zt7cHFnQ%3D%3D&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=NCT06191744&index=4&md5=82cb23566ec60e7d683c8d2dc679d018)\n). The safety and efficacy of epcoritamab has not been established for these\ninvestigational uses. Please visit www.clinicaltrials.gov\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DbfzHFRn1Lh91NWWRRYKXR4xbLwPWBa6XOkcvCYj8f1hENwR0g77EzlGnS84_ql29nXadK_yBAKtp_JytgkmMv7vQqVBnu41-dvo3Yk5A9FGK_mPS0xP35_sRwIN0iYKi3CYqLiCBd6FY8DNh7LQ-tY2zigufvgsjvwSHafHWuvt46imKKSk_TEjJc1jkIb3L3rSwF_7AP4dC9hl42lzRhhmypAKU04DuGeLaPXUBy1ZTEv6yOkyEEwqoEYQvAxsYxNIQH52AGspTTl83y7bHiDsEPEmbExEd765_QLR6dLc%3D&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=www.clinicaltrials.gov&index=5&md5=29be163cfae6b51f9223d97a1fa5532b)\nfor more information.\n\nWhat is EPKINLY?\n\nEPKINLY is a prescription medicine used to treat adults with:\n\n\n * certain types of diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell\nlymphoma that has come back (relapsed) or that did not respond (refractory)\nafter 2 or more treatments.\n\n * follicular lymphoma (FL) that has come back or that did not respond to\nprevious treatment, together with lenalidomide and rituximab\n\n * follicular lymphoma (FL) that has come back or that did not respond after 2 or\nmore treatments.\n\nEPKINLY for the treatment of DLBCL is approved based on patient response data.\nStudies are ongoing to confirm the clinical benefit of EPKINLY.\n\nIt is not known if EPKINLY is safe and effective in children.\n\nIMPORTANT SAFETY INFORMATION\n\nImportant Warnings—EPKINLY can cause serious side effects, including:\n\n\n * Cytokine release syndrome (CRS), which is common during treatment with EPKINLY\nand can be serious or lead to death. To help reduce your risk of CRS, you will\nreceive EPKINLY on a step-up dosing schedule (when you receive 2 or 3 smaller\nstep-up doses of EPKINLY before your first full dose during your first cycle\nof treatment), and you may also receive other medicines before and for 3 days\nafter receiving EPKINLY. If your dose of EPKINLY is delayed for any reason,\nyou may need to repeat the step-up dosing schedule.\n\n * Neurologic problems that can be serious, and can be life-threatening, and lead\nto death. Neurologic problems may happen days or weeks after you receive\nEPKINLY.\n\nPeople with DLBCL or high-grade B-cell lymphoma may be hospitalized after\nreceiving their first full dose of EPKINLY on Day 15 of Cycle 1 due to the\nrisk of CRS and neurologic problems.\n\nPeople with FL may be hospitalized after receiving their first full dose of\nEPKINLY on Day 22 of Cycle 1 due to the risk of CRS and neurologic problems.\n\nTell your healthcare provider or get medical help right away if you develop a\nfever of 100.4°F (38°C) or higher; dizziness or lightheadedness; trouble\nbreathing; chills; fast heartbeat; feeling anxious; headache; confusion;\nshaking (tremors); problems with balance and movement, such as trouble\nwalking; trouble speaking or writing; confusion and disorientation;\ndrowsiness, tiredness or lack of energy; muscle weakness; seizures; or memory\nloss. These may be symptoms of CRS or neurologic problems. If you have any\nsymptoms that impair consciousness, do not drive or use heavy machinery or do\nother dangerous activities until your symptoms go away.\n\nEPKINLY can cause other serious side effects, including:\n\n\n * Infections that may lead to death. Your healthcare provider will check you for\nsigns and symptoms of infection before and during treatment and treat you as\nneeded if you develop an infection. You should receive medicines from your\nhealthcare provider before you start treatment to help prevent infection. Tell\nyour healthcare provider right away if you develop any symptoms of infection\nduring treatment, including fever of 100.4°F (38°C) or higher, cough, chest\npain, tiredness, shortness of breath, painful rash, sore throat, pain during\nurination, feeling weak or generally unwell, or confusion.\n\n * Low blood cell counts, which can be serious or severe. Your healthcare\nprovider will check your blood cell counts during treatment. EPKINLY may cause\nlow blood cell counts, including low white blood cells (neutropenia and\nlymphopenia), which can increase your risk for infection; low red blood cells\n(anemia), which can cause tiredness and shortness of breath; and low platelets\n(thrombocytopenia), which can cause bruising or bleeding problems.\n\nYour healthcare provider will monitor you for symptoms of CRS, neurologic\nproblems, infections, and low blood cell counts during treatment with EPKINLY.\nYour healthcare provider may temporarily stop or completely stop treatment\nwith EPKINLY if you develop certain side effects.\n\nBefore you receive EPKINLY, tell your healthcare provider about all your\nmedical conditions, including if you have an infection, are pregnant or plan\nto become pregnant, or are breastfeeding or plan to breastfeed. If you receive\nEPKINLY while pregnant, it may harm your unborn baby. If you are a female who\ncan become pregnant, your healthcare provider should do a pregnancy test\nbefore you start treatment with EPKINLY and you should use effective birth\ncontrol (contraception) during treatment and for 4 months after your last dose\nof EPKINLY. Tell your healthcare provider if you become pregnant or think that\nyou may be pregnant during treatment with EPKINLY. Do not breastfeed during\ntreatment with EPKINLY and for 4 months after your last dose of EPKINLY.\n\nThe most common side effects of EPKINLY when used alone in DLBCL or high-grade\nB-cell lymphoma or FL include CRS, injection site reactions, tiredness, muscle\nand bone pain, fever, diarrhea, COVID-19, rash, and stomach-area (abdominal)\npain. The most common severe abnormal laboratory test results with EPKINLY\nwhen used alone include decreased white blood cells, decreased red blood\ncells, and decreased platelets.\n\nThe most common side effects of EPKINLY when used together with lenalidomide\nand rituximab in FL include rash, upper respiratory tract infections,\ntiredness, injection site reactions, constipation, diarrhea, CRS, pneumonia,\nCOVID-19, and fever. The most common severe abnormal laboratory test results\nwith EPKINLY when used together with lenalidomide and rituximab include\ndecreased white blood cells and decreased platelets.\n\nThese are not all of the possible side effects of EPKINLY. Call your doctor\nfor medical advice about side effects.\n\nYou are encouraged to report side effects to the FDA at (800) FDA-1088 or\nwww.fda.gov/medwatch\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.fda.gov%2Fmedwatch&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=www.fda.gov%2Fmedwatch&index=6&md5=21ebe92335b7542e0e039e99e971c62a)\nor to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622).\n\nPlease see Medication Guide\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3D0nNmIx4vqub1K9518mfJF9wZOtU0NL9JSrYacoVHqQKvvS15Z5LgbjNkPBCNAHDVV0dm7lvith45O2eyzGYoH7289L7d_U-y6tF3L5fG4Tl7JV_d86vXhOWDycrH-3GA9qgT3aEqjfn0OIcXTXB1ztGsD7EHKtNvD_GDCQExDX4t_Fi5C2YUqWg5n9MPLqTwUph5aBxsjuhxCdMsSKw2IJBuGNcorMn_R-l971H2hZ3liWvDtyhjRsl1wWDdhMjGQZwK9gvSJPBIY2wpcz1pbAA8XwkPVF8ypjFm7OOLO1B77NKgxMA3TUiBfo2n_JzKYSu_FR-rW1vSIdgnWPIXTg%3D%3D&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=Medication+Guide&index=7&md5=ec1da49d9eeee4b5b59e4054a62b942a)\n, including Important Warnings.\n\nGenmab A/S Tel: +45 7020 2728 Company Announcement no. xx\n\nCarl Jacobsens Vej 30 Page /\n\n2500 Valby, Denmark CVR no. 2102 3884\n\nLEI Code 529900MTJPDPE4MHJ122\n\nAbout Genmab\n\nGenmab is an international biotechnology company dedicated to improving the\nlives of people with cancer and other serious diseases through innovative\nantibody medicines. For over 25 years, its passionate, innovative and\ncollaborative team has advanced a broad range of antibody-based therapeutic\nformats, including bispecific antibodies, antibody-drug conjugates (ADCs),\nimmune-modulating antibodies and other next-generation modalities. Genmab’s\nscience powers eight approved antibody medicines, and the company is advancing\na strong late-stage clinical pipeline, including wholly owned programs, with\nthe goal of delivering transformative medicines to patients.\n\nEstablished in 1999, Genmab is headquartered in Copenhagen, Denmark, with\ninternational presence across North America, Europe and Asia Pacific. For\nmore information, please visit Genmab.com or follow us on LinkedIn\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3D-L61Myomg4CzRnh1GNsJd2D9RTjJ2xQeJph4tvLFd8m6p-6KMYzRKHh8wGaP56a_nKzCa7CQZEyJqPyi1PujT5lQIWhoMKFEveIAZKbWQzM%3D&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=LinkedIn&index=8&md5=d46db30a9e937a31a2a8f8402bc9e4d3)\n, X\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3D-FmdIE15VSb91gaAkFTOKF9jybga5r0ADyADmP3-CMdNn8Q8tYVj-jk6sMYbhNubT_0DplMHzrsbd-OkQMLXqw%3D%3D&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=X&index=9&md5=ee57dee6a4c24a7a3523c356e58b9a99)\n, Facebook\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.facebook.com%2Fshare%2F1DdeiTZ7H4%2F%3Fmibextid%3DwwXIfr&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=Facebook&index=10&md5=99038942cdf2e956474814df2336c73a)\n and Instagram\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.instagram.com%2Fgenmab.biotech%3Figsi%3DcHU4czE2azJkMm01&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=Instagram&index=11&md5=503bf384c1ab308071aa99c619d33f89)\n.\n\nAbout AbbVie in Oncology\n\nAbbVie is committed to elevating standards of care and bringing transformative\ntherapies to patients worldwide living with difficult-to-treat cancers. We are\nadvancing a dynamic pipeline of investigational therapies across a range of\ncancer types in both blood cancers and solid tumors. We are focusing on\ncreating targeted medicines that either impede the reproduction of cancer\ncells or enable their elimination. We achieve this through various, targeted\ntreatment modalities and biology interventions, including small molecule\ntherapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based\ntherapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated\nand experienced team joins forces with innovative partners to accelerate the\ndelivery of potential breakthrough medicines.\n\nToday, our expansive oncology portfolio is comprised of approved and\ninvestigational treatments for a wide range of blood and solid tumors. We are\nevaluating more than 35 investigational medicines across some of the world's\nmost widespread and debilitating cancers. As we work to have a remarkable\nimpact on people's lives, we are committed to exploring solutions to help\npatients obtain access to our cancer medicines. For more information, please\nvisit us at http://www.abbvie.com/oncology\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fedge.prnewswire.com%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4597855-1%26h%3D644583804%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D4200900-1%2526h%253D237160949%2526u%253Dhttps%25253A%25252F%25252Fc212.net%25252Fc%25252Flink%25252F%25253Ft%25253D0%252526l%25253Den%252526o%25253D4183333-1%252526h%25253D396968399%252526u%25253Dhttp%2525253A%2525252F%2525252Fwww.abbvie.com%2525252Foncology%252526a%25253Dhttp%2525253A%2525252F%2525252Fwww.abbvie.com%2525252Foncology%2526a%253Dhttp%25253A%25252F%25252Fwww.abbvie.com%25252Foncology%26a%3Dhttp%253A%252F%252Fwww.abbvie.com%252Foncology&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=http%3A%2F%2Fwww.abbvie.com%2Foncology&index=12&md5=7f5fa041b55d1ddd3546d4ec5db39061)\n.\n\nAbout AbbVie\n\nAbbVie's mission is to discover and deliver innovative medicines and solutions\nthat solve serious health issues today and address the medical challenges of\ntomorrow. We strive to have a remarkable impact on people's lives across\nseveral key therapeutic areas including immunology, neuroscience and oncology\n– and products and services in our Allergan Aesthetics portfolio. For more\ninformation about AbbVie, please visit us at www.abbvie.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.abbvie.com&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=www.abbvie.com&index=13&md5=ea3e2930b2821a9a2309170c600d02dc)\n. Follow @abbvie on LinkedIn\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fabbvie%2F&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=LinkedIn&index=14&md5=c4dcfe322b9b0f063774ecd78076ce0b)\n, Facebook\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.facebook.com%2FAbbVieGlobal%2F&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=Facebook&index=15&md5=0380659c51fdb8a40cc81a37574009ec)\n, Instagram\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.instagram.com%2Fabbvie%2F&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=Instagram&index=16&md5=342602fbea96b60977b3bb520973d47a)\n, X\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Ftwitter.com%2Fabbvie&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=X&index=17&md5=78604862f7d879dfb0007846688b6210)\nand YouTube\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.youtube.com%2Fuser%2FAbbVie&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=YouTube&index=18&md5=490ac3b32a8048ab5edbe79ef6427e11)\n.\n\nGenmab Forward-Looking Statements\n\nThis Company Announcement contains forward looking statements. The words\n“believe,” “expect,” “anticipate,” “intend” and “plan” and\nsimilar expressions identify forward looking statements. Actual results or\nperformance may differ materially from any future results or performance\nexpressed or implied by such statements. The important factors that could\ncause our actual results or performance to differ materially include, among\nothers, risks associated with preclinical and clinical development of\nproducts, uncertainties related to the outcome and conduct of clinical trials\nincluding unforeseen safety issues, uncertainties related to product\nmanufacturing, the lack of market acceptance of our products, our inability to\nmanage growth, the competitive environment in relation to our business area\nand markets, our inability to attract and retain suitably qualified personnel,\nthe unenforceability or lack of protection of our patents and proprietary\nrights, our relationships with affiliated entities, changes and developments\nin technology which may render our products or technologies obsolete, and\nother factors. For a further discussion of these risks, please refer to the\nrisk management sections in Genmab’s most recent financial reports, which\nare available on www.genmab.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DbfzHFRn1Lh91NWWRRYKXR6gMkb0xx1vgslT_nW-gUyJw-N9YMcqzB1NQ3pIp6hNqzxIRmbGbqiaoZyel-soJq-daspA9Jk4KbvHriAZpyy8%3D&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=www.genmab.com&index=19&md5=967720137fcecf1ccab1a86bb8959fa2)\nand the risk factors included in Genmab’s most recent Annual Report on Form\n20-F and other filings with the U.S. Securities and Exchange Commission (SEC),\nwhich are available at www.sec.gov\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DbfzHFRn1Lh91NWWRRYKXR7psSmoozpdjwWBdoMUEzYPiYaxV5Pu72SKSUlk2E-FV-tMObx0NGzgw61AsZUiT5Q%3D%3D&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=www.sec.gov&index=20&md5=a84f3a85dd137e07fa53b2910448a160)\n. Genmab does not undertake any obligation to update or revise forward looking\nstatements in this Company Announcement nor to confirm such statements to\nreflect subsequent events or circumstances after the date made or in relation\nto actual results, unless required by law.\n\nGenmab A/S and/or its subsidiaries own the following trademarks: Genmab(®);\nthe Y-shaped Genmab logo(®); Genmab in combination with the Y-shaped Genmab\nlogo(®); HuMax(®); DuoBody(®); HexaBody(®); DuoHexaBody(®), HexElect(®\n)and KYSO™. EPCORE(®), EPKINLY(®), TEPKINLY(®) and their designs are\ntrademarks of AbbVie Biotechnology Ltd. Dr. Salles has financial interests\nrelated to AbbVie and Genmab.\n\nAbbVie Forward-Looking Statements\n\nSome statements in this news release are, or may be considered,\nforward-looking statements for purposes of the Private Securities Litigation\nReform Act of 1995. The words \"believe,\" \"expect,\" \"anticipate,\" \"project\" and\nsimilar expressions and uses of future or conditional verbs, generally\nidentify forward-looking statements. AbbVie cautions that these\nforward-looking statements are subject to risks and uncertainties that may\ncause actual results to differ materially from those expressed or implied in\nthe forward-looking statements. Such risks and uncertainties include, but are\nnot limited to, challenges to intellectual property, competition from other\nproducts, difficulties inherent in the research and development process,\nadverse litigation or government action, changes to laws and regulations\napplicable to our industry, the impact of global macroeconomic factors, such\nas economic downturns or uncertainty, international conflict, trade disputes\nand tariffs, and other uncertainties and risks associated with global business\noperations. Additional information about the economic, competitive,\ngovernmental, technological and other factors that may affect AbbVie's\noperations is set forth in Item 1A, \"Risk Factors,\" of AbbVie's 2025 Annual\nReport on Form 10-K, which has been filed with the Securities and Exchange\nCommission, as updated by its Quarterly Reports on Form 10-Q and in other\ndocuments that AbbVie subsequently files with the Securities and Exchange\nCommission that update, supplement or supersede such information. AbbVie\nundertakes no obligation, and specifically declines, to release publicly any\nrevisions to forward-looking statements as a result of subsequent events or\ndevelopments, except as required by law.\n\n_______________________________\n\n(i) Lymphoma Research Foundation. Diffuse Large B-Cell Lymphoma. Accessed\nFebruary 2026.\nhttps://lymphoma.org/understanding-lymphoma/aboutlymphoma/nhl/dlbcl/ \n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DpHH_sfAlu8-x7jU2sSUrjQzOj6_c66axXS5GyAZdE6mteO7jJcT9h_cPX0hOJ4TlJyDZezkdGqYwIiz86cSCENY455VeCOfV3tEJ_KqAZ8BtXSfqfZxCsksx3tJ6d8UngYu_0V2qvPJcfF9IyDpaPdS4rilvqRL3od-rdb9GQJ-WTXD3T34URO4358KhAA-keNH4MfG9lDest9CrcribEsLP19cgLDBgjQ8nui_shKs%3D&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=https%3A%2F%2Flymphoma.org%2Funderstanding-lymphoma%2Faboutlymphoma%2Fnhl%2Fdlbcl%2F&index=21&md5=a425175159b43300dd9fe8588e28d7b8)\n\n(ii) Padala, et al. Diffuse Large B-Cell Lymphoma. StatPearls [Internet].\nTreasure Island (FL): StatPearls Publishing; 2024 Jan. 2023 Apr 24.\n\n(iii) Leukemia and Lymphoma Society. Diffuse Large B-Cell Lymphoma (DLBCL).\nAccessed February 2026.\nhttps://www.lls.org/research/diffuse-large-b-cell-lymphoma-dlbcl \n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DpHH_sfAlu8-x7jU2sSUrjWuRrOfMb-_gZ1ZyPeF6ijY-tgZSHq78o2OtkAb0Y1Qwf37n9rKsdWU8qDW1W_syoCU_D_OrLv_u5OMmUskf0_U9SDfvxoFinIUPVZN1LALTlPP5TbdWimE2M-43yPoiJZuoDj2wfyVOXwQQoeKiCly3e8csJB3RIOQZV9F_FIQ82lmHevPB7eDZQKzItLsKYzCAr_kqZoRunBxRZz2DZE5MfuaBntnWJDJCkU9kIYKhZbpYWzKlKmzjAO2rWjXJxkKayj2iXrX1Gau00GBksmDa2ljsA3vL611eF1y2Y_AbuWV9-5NOO9LwXOO49vKkAjHEGcid3ZIMkE4g-dVc8T930mrfiMpjaWKOFkbUXvSqlQTdaOcexNx2Slj8losdeGE1FsRTpPm-uwBkYvrAWUE%3D&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=https%3A%2F%2Fwww.lls.org%2Fresearch%2Fdiffuse-large-b-cell-lymphoma-dlbcl&index=22&md5=3aa763631a83c49370906b07ec647c74)\n\n(iv) Sehn, et al. Diffuse Large B-Cell Lymphoma. N Engl J Med.\n2021;384:842-858. doi: 10.1056/NEJMra2027612.\n\n(v) Kanas, et al. Epidemiology of Diffuse Large B-Cell Lymphoma (DLBCL) and\nFollicular Lymphoma (FL) in the United States and Western Europe:\nPopulation-Level Projections for 2020-2025. Leuk Lymphoma. 2022;63(1):54-63.\ndoi: 10.1080/10428194.2021.1975188.\n\n(vi) Crump, et al. Outcomes in Refractory Diffuse Large B-Cell Lymphoma:\nResults From the International SCHOLAR-1 Study. Blood. 2017;130(16):1800-1808.\ndoi: 10.1182/blood-2017-03-769620.\n\n(vii) Engelberts PJ, Hiemstra IH, de Jong B, et al. DuoBody-CD3xCD20 induces\npotent T-cell-mediated killing of malignant B cells in preclinical models and\nprovides opportunities for subcutaneous dosing. EBioMedicine. 2020;52:102625.\nDOI: 10.1016/j.ebiom.2019.102625.\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20261005374420/en/\n(https://www.businesswire.com/news/home/20261005374420/en/)\n\nGenmab Contacts: \n\nMarisol Peron, Senior Vice President, Global Communications & Corporate\nAffairs\n\nT: +1 609 524 0065; E: mmp@genmab.com (mailto:mmp@genmab.com)\n\nAndrew Carlsen, Vice President, Head of Investor Relations\n\nT: +45 3377 9558; E: acn@genmab.com (mailto:acn@genmab.com)\n\nAbbVie Contacts: \n\nRaquel Powers, Director, Oncology Public Affairs\n\nT: +1 847 935 6563; E: raquel.powers@abbvie.com\n(mailto:raquel.powers@abbvie.com)\n\nTodd Bosse, Vice President, Investor Relations\n\nT: +1 847-936-1182; E: todd.bosse@abbvie.com (mailto:todd.bosse@abbvie.com)\n\n\nCopyright Business Wire 2026","article_body_html":"","raw_payload":{"data":{"id":"nBw6htZ3Ja-20261005","title":"Genmab and AbbVie Announce Epcoritamab in Combination with R-CHOP Demonstrates Statistically Significant Improvement in Progression-Free Survival in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma","author":"Business Wire","ticker":"ABBV","created":"2026-10-05T18:50:00.104Z","tickers":["ABBV","GMAB"],"exchange":"NYSE","article_body":"Genmab and AbbVie Announce Epcoritamab in Combination with R-CHOP Demonstrates\nStatistically Significant Improvement in Progression-Free Survival in Patients\nwith Newly Diagnosed Diffuse Large B-Cell Lymphoma\n\n\n * EPCORE DLBCL-2 is the first Phase 3 study of a bispecific antibody combination\ntherapy to demonstrate statistically significant and clinically meaningful\nimprovement in progression-free survival (PFS) in frontline diagnosed diffuse\nlarge B-cell lymphoma (DLBCL) patients\n\n * Based on the topline results, Genmab and AbbVie will engage global regulatory\nauthorities\n\nGenmab A/S\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.genmab.com&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=Genmab+A%2FS&index=1&md5=19471c08d31b51e45c1f4c2155fe5539)\n(Nasdaq: GMAB) and AbbVie (NYSE: ABBV) announced today positive topline\nresults from the Phase 3 EPCORE DLBCL-2 trial evaluating fixed treatment\nduration epcoritamab, a T-cell engaging bispecific antibody administered\nsubcutaneously, in combination with standard of care rituximab,\ncyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone\n(R-CHOP), compared to R-CHOP alone, in newly diagnosed patients with diffuse\nlarge B-cell lymphoma (DLBCL) with an International Prognostic Index (IPI)\nscore of 2 to 5. The trial demonstrated a statistically significant and\nclinically meaningful improvement in progression-free survival (PFS) in DLBCL\npatients with an IPI score of 2 to 5. The risk of disease progression or death\nwas reduced by 51% (HR 0.49 [95% CI 0.36, 0.67]; p-value < 0.0001). The\nsafety profile of epcoritamab when administered in combination with standard\nof care R-CHOP was generally well tolerated and consistent with the previously\nreported safety profiles of the individual agents (epcoritamab and R-CHOP).\n\n“These topline results of epcoritamab in combination with R-CHOP mark the\nfirst Phase 3 study to demonstrate a statistically significant improvement in\nprogression-free survival in patients with newly diagnosed DLBCL treated with\na bispecific antibody combination and have the potential to reshape the\nfrontline treatment landscape,” said Jan van de Winkel, Ph.D., Chief\nExecutive Officer of Genmab. “While treatment advances have improved\noutcomes for patients with diffuse large B-cell lymphoma, options for newly\ndiagnosed patients remain limited, reinforcing the need for additional\ntherapies that can treat as many patients as possible in the frontline\nsetting.”\n\n“DLBCL is an aggressive disease and the need to advance treatment options is\ncritical. These positive topline results suggest that epcoritamab combined\nwith R-CHOP could offer a potential new standard of care in newly diagnosed\nDLBCL patients,” said Daejin Abidoye, MD, vice president, therapeutic area\nhead, oncology, solid tumor and hematology, AbbVie. “The findings further\nstrengthen our understanding and potential of bispecifics across the lymphoma\ntreatment landscape, as we work to address urgent needs in this patient\npopulation.”\n\n\"As an investigator with firsthand experience in both the landmark trial that\nestablished R-CHOP as a standard of care nearly 25 years ago and EPCORE\nDLBCL-2, it is particularly meaningful to see the potential benefit of\nbispecific antibody therapy in newly diagnosed diffuse large B-cell\nlymphoma,” said Gilles Salles, MD, PhD, Chief of the Lymphoma Service and\nholder of the Steven A. Greenberg Chair at Memorial Sloan Kettering Cancer\nCenter. “The 51% reduction in the risk of progression or death is clinically\nmeaningful and highly relevant to everyday practice. These results have the\npotential to be practice-changing and could mark an important step forward in\nbringing the opportunity of cure to more patients.”\n\nData will be submitted for presentation at a future medical meeting. Genmab\nand AbbVie will engage global regulatory authorities to determine next steps.\nEpcoritamab plus R-CHOP is an investigational combination not approved by\nregulatory authorities.\n\nAbout the EPCORE(®) DLBCL-2 Trial\n\nEPCORE DLBCL-2 (NCT05578976\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fnam12.safelinks.protection.outlook.com%2F%3Furl%3Dhttps%253A%252F%252Fclinicaltrials.gov%252Fstudy%252FNCT05578976%26data%3D05%257C02%257Cmatt.skryja%2540abbvie.com%257C0543693c4438400461cc08df1fea3a40%257C6f4d03de95514ba1a25bdce6f5ab7ace%257C0%257C0%257C639264763066608281%257CUnknown%257CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%253D%253D%257C0%257C%257C%257C%26sdata%3DzZw6Pcu7AUQRTqIKncfU03s8x6QxbNuQg7%252BOQ9lWHT8%253D%26reserved%3D0&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=NCT05578976&index=2&md5=694bceea6b0e81ca1ff9fbd6787ba1aa)\n) is a global Phase 3 open label, multi-center, randomized trial to evaluate\nthe efficacy of fixed duration, subcutaneous epcoritamab (GEN3013,\nDuoBody(®)-CD3xCD20) and standard of care rituximab, cyclophosphamide,\ndoxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) compared to\nR-CHOP alone in patients with newly diagnosed large B-cell lymphoma (DLBCL).\nThe trial enrolled subjects with an International Prognostic Index (IPI) score\nof 2 to 5, including patients with diffuse large B-cell lymphoma, not\notherwise specified (DLBCL, NOS), high-grade B-Cell lymphoma (HGBL) with MYC\nand BCL2 and/or BCL6 rearrangements, follicular lymphoma grade 3B (FL3B),\nT-cell/histiocyte-rich large B-Cell lymphoma (TCHR LBLC), and Epstein-Barr\nVirus-positive diffuse large B-cell lymphoma (EBV+ DLBCL). The primary\nendpoint is PFS in participants with an International Prognostic Index (IPI)\nof 3-5 and the key secondary endpoint is PFS in total participants (IPI score\nof 2-5). The risk of disease progression or death for the primary endpoint\npopulation was reduced by 51% (HR 0.49 [95% CI 0.35, 0.69]; p-value <\n0.0001). Patients were randomized 2:1 to receive a fixed-duration regimen of\nepcoritamab plus R-CHOP for six cycles followed by epcoritamab alone for two\ncycles, or R-CHOP for six cycles followed by rituximab for two cycles. The\ntrial started on February 8, 2023, and is ongoing.\n\nMore information on this trial can be found at\nhttps://clinicaltrials.gov/study/NCT05578976\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT05578976&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT05578976&index=3&md5=d03ad7cf44f19918d263128883734d8b)\n(NCT: NCT05578976).\n\nAbout Diffuse Large B-Cell Lymphoma\n\nDiffuse large B-cell lymphoma (DLBCL) DLBCL is the most common type of\nnon-Hodgkin lymphoma (NHL) worldwide, accounting for approximately 25-30\npercent of all NHL cases.(i,ii) In the U.S., there are approximately 25,000\nnew cases of DLBCL diagnosed each year.(iii) DLBCL can arise in lymph nodes as\nwell as in organs outside of the lymphatic system, occurs more commonly in the\nelderly and is slightly more prevalent in men.(iv,v) DLBCL is a fast-growing\ntype of NHL, a cancer that develops in the lymphatic system and affects B-cell\nlymphocytes, a type of white blood cell. For many people living with DLBCL,\ntheir cancer either relapses, which means it may return after treatment, or\nbecomes refractory, meaning it does not respond to treatment. Although new\ntherapies have become available, treatment management can remain a\nchallenge.(iv,vi)\n\nAbout Epcoritamab\n\nEpcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary\nDuoBody technology and administered subcutaneously. Genmab's DuoBody-CD3\ntechnology is designed to direct cytotoxic T cells selectively to elicit an\nimmune response toward target cell types. Epcoritamab is designed to\nsimultaneously bind to CD3 on T cells and CD20 on B cells and induces\nT-cell-mediated killing of CD20+ cells.(vii)\n\nEpcoritamab (approved under the brand name EPKINLY(®) in the U.S. and Japan,\nand TEPKINLY(®) in the EU) has received regulatory approval in certain\nlymphoma indications in more than 65 countries. Where approved, epcoritamab is\na readily accessible therapy. Epcoritamab is being co-developed by Genmab and\nAbbVie as part of the companies' oncology collaboration. The companies share\ncommercial responsibilities in the U.S. and Japan, with AbbVie responsible for\nfurther global commercialization. Both companies will pursue additional\ninternational regulatory approvals for the relapsed or refractory (R/R)\nfollicular lymphoma (FL) indication and additional approvals for the R/R\ndiffuse large B-cell lymphoma (DLBCL) indication.\n\nGenmab and AbbVie continue to evaluate the use of epcoritamab as a\nmonotherapy, and in combination, across lines of therapy in a range of\nhematologic malignancies. This includes a trial evaluating epcoritamab in\ncombination with lenalidomide and rituximab (R(2)) compared to\nchemoimmunotherapy in patients with previously untreated FL (NCT06191744\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DRx84t76qIlVSOQSq3AC0Avc1qtLHERYiz7MuDCb1vhFIu7yT1MhlmYfH8uZAIzhDOROYWIyoXmUrmzcavhj5Qa_9W9P4yZkg2MWmNmiVlnnW_eNXiRShDP33e9AmiUAyTBjYnsgAXCRdLKfvYlCEBfGTMce6y3oM1tPFtp51PKtkj4BASginJgAPzbZcKEaoc8gXl4xpmgzfzuU1NcHL6xV8ptBO_DrK3HIMXJwiqOYJJJzkwFNOO9oOEiOBRJTJJXtXHhnoA44hl_WXYX3S3k90F92SURGhTOdoujS6935KPV_liUHiuTkyv-CxkzP2m95EDd-BB2il14zt7cHFnQ%3D%3D&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=NCT06191744&index=4&md5=82cb23566ec60e7d683c8d2dc679d018)\n). The safety and efficacy of epcoritamab has not been established for these\ninvestigational uses. Please visit www.clinicaltrials.gov\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DbfzHFRn1Lh91NWWRRYKXR4xbLwPWBa6XOkcvCYj8f1hENwR0g77EzlGnS84_ql29nXadK_yBAKtp_JytgkmMv7vQqVBnu41-dvo3Yk5A9FGK_mPS0xP35_sRwIN0iYKi3CYqLiCBd6FY8DNh7LQ-tY2zigufvgsjvwSHafHWuvt46imKKSk_TEjJc1jkIb3L3rSwF_7AP4dC9hl42lzRhhmypAKU04DuGeLaPXUBy1ZTEv6yOkyEEwqoEYQvAxsYxNIQH52AGspTTl83y7bHiDsEPEmbExEd765_QLR6dLc%3D&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=www.clinicaltrials.gov&index=5&md5=29be163cfae6b51f9223d97a1fa5532b)\nfor more information.\n\nWhat is EPKINLY?\n\nEPKINLY is a prescription medicine used to treat adults with:\n\n\n * certain types of diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell\nlymphoma that has come back (relapsed) or that did not respond (refractory)\nafter 2 or more treatments.\n\n * follicular lymphoma (FL) that has come back or that did not respond to\nprevious treatment, together with lenalidomide and rituximab\n\n * follicular lymphoma (FL) that has come back or that did not respond after 2 or\nmore treatments.\n\nEPKINLY for the treatment of DLBCL is approved based on patient response data.\nStudies are ongoing to confirm the clinical benefit of EPKINLY.\n\nIt is not known if EPKINLY is safe and effective in children.\n\nIMPORTANT SAFETY INFORMATION\n\nImportant Warnings—EPKINLY can cause serious side effects, including:\n\n\n * Cytokine release syndrome (CRS), which is common during treatment with EPKINLY\nand can be serious or lead to death. To help reduce your risk of CRS, you will\nreceive EPKINLY on a step-up dosing schedule (when you receive 2 or 3 smaller\nstep-up doses of EPKINLY before your first full dose during your first cycle\nof treatment), and you may also receive other medicines before and for 3 days\nafter receiving EPKINLY. If your dose of EPKINLY is delayed for any reason,\nyou may need to repeat the step-up dosing schedule.\n\n * Neurologic problems that can be serious, and can be life-threatening, and lead\nto death. Neurologic problems may happen days or weeks after you receive\nEPKINLY.\n\nPeople with DLBCL or high-grade B-cell lymphoma may be hospitalized after\nreceiving their first full dose of EPKINLY on Day 15 of Cycle 1 due to the\nrisk of CRS and neurologic problems.\n\nPeople with FL may be hospitalized after receiving their first full dose of\nEPKINLY on Day 22 of Cycle 1 due to the risk of CRS and neurologic problems.\n\nTell your healthcare provider or get medical help right away if you develop a\nfever of 100.4°F (38°C) or higher; dizziness or lightheadedness; trouble\nbreathing; chills; fast heartbeat; feeling anxious; headache; confusion;\nshaking (tremors); problems with balance and movement, such as trouble\nwalking; trouble speaking or writing; confusion and disorientation;\ndrowsiness, tiredness or lack of energy; muscle weakness; seizures; or memory\nloss. These may be symptoms of CRS or neurologic problems. If you have any\nsymptoms that impair consciousness, do not drive or use heavy machinery or do\nother dangerous activities until your symptoms go away.\n\nEPKINLY can cause other serious side effects, including:\n\n\n * Infections that may lead to death. Your healthcare provider will check you for\nsigns and symptoms of infection before and during treatment and treat you as\nneeded if you develop an infection. You should receive medicines from your\nhealthcare provider before you start treatment to help prevent infection. Tell\nyour healthcare provider right away if you develop any symptoms of infection\nduring treatment, including fever of 100.4°F (38°C) or higher, cough, chest\npain, tiredness, shortness of breath, painful rash, sore throat, pain during\nurination, feeling weak or generally unwell, or confusion.\n\n * Low blood cell counts, which can be serious or severe. Your healthcare\nprovider will check your blood cell counts during treatment. EPKINLY may cause\nlow blood cell counts, including low white blood cells (neutropenia and\nlymphopenia), which can increase your risk for infection; low red blood cells\n(anemia), which can cause tiredness and shortness of breath; and low platelets\n(thrombocytopenia), which can cause bruising or bleeding problems.\n\nYour healthcare provider will monitor you for symptoms of CRS, neurologic\nproblems, infections, and low blood cell counts during treatment with EPKINLY.\nYour healthcare provider may temporarily stop or completely stop treatment\nwith EPKINLY if you develop certain side effects.\n\nBefore you receive EPKINLY, tell your healthcare provider about all your\nmedical conditions, including if you have an infection, are pregnant or plan\nto become pregnant, or are breastfeeding or plan to breastfeed. If you receive\nEPKINLY while pregnant, it may harm your unborn baby. If you are a female who\ncan become pregnant, your healthcare provider should do a pregnancy test\nbefore you start treatment with EPKINLY and you should use effective birth\ncontrol (contraception) during treatment and for 4 months after your last dose\nof EPKINLY. Tell your healthcare provider if you become pregnant or think that\nyou may be pregnant during treatment with EPKINLY. Do not breastfeed during\ntreatment with EPKINLY and for 4 months after your last dose of EPKINLY.\n\nThe most common side effects of EPKINLY when used alone in DLBCL or high-grade\nB-cell lymphoma or FL include CRS, injection site reactions, tiredness, muscle\nand bone pain, fever, diarrhea, COVID-19, rash, and stomach-area (abdominal)\npain. The most common severe abnormal laboratory test results with EPKINLY\nwhen used alone include decreased white blood cells, decreased red blood\ncells, and decreased platelets.\n\nThe most common side effects of EPKINLY when used together with lenalidomide\nand rituximab in FL include rash, upper respiratory tract infections,\ntiredness, injection site reactions, constipation, diarrhea, CRS, pneumonia,\nCOVID-19, and fever. The most common severe abnormal laboratory test results\nwith EPKINLY when used together with lenalidomide and rituximab include\ndecreased white blood cells and decreased platelets.\n\nThese are not all of the possible side effects of EPKINLY. Call your doctor\nfor medical advice about side effects.\n\nYou are encouraged to report side effects to the FDA at (800) FDA-1088 or\nwww.fda.gov/medwatch\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.fda.gov%2Fmedwatch&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=www.fda.gov%2Fmedwatch&index=6&md5=21ebe92335b7542e0e039e99e971c62a)\nor to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622).\n\nPlease see Medication Guide\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3D0nNmIx4vqub1K9518mfJF9wZOtU0NL9JSrYacoVHqQKvvS15Z5LgbjNkPBCNAHDVV0dm7lvith45O2eyzGYoH7289L7d_U-y6tF3L5fG4Tl7JV_d86vXhOWDycrH-3GA9qgT3aEqjfn0OIcXTXB1ztGsD7EHKtNvD_GDCQExDX4t_Fi5C2YUqWg5n9MPLqTwUph5aBxsjuhxCdMsSKw2IJBuGNcorMn_R-l971H2hZ3liWvDtyhjRsl1wWDdhMjGQZwK9gvSJPBIY2wpcz1pbAA8XwkPVF8ypjFm7OOLO1B77NKgxMA3TUiBfo2n_JzKYSu_FR-rW1vSIdgnWPIXTg%3D%3D&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=Medication+Guide&index=7&md5=ec1da49d9eeee4b5b59e4054a62b942a)\n, including Important Warnings.\n\nGenmab A/S Tel: +45 7020 2728 Company Announcement no. xx\n\nCarl Jacobsens Vej 30 Page /\n\n2500 Valby, Denmark CVR no. 2102 3884\n\nLEI Code 529900MTJPDPE4MHJ122\n\nAbout Genmab\n\nGenmab is an international biotechnology company dedicated to improving the\nlives of people with cancer and other serious diseases through innovative\nantibody medicines. For over 25 years, its passionate, innovative and\ncollaborative team has advanced a broad range of antibody-based therapeutic\nformats, including bispecific antibodies, antibody-drug conjugates (ADCs),\nimmune-modulating antibodies and other next-generation modalities. Genmab’s\nscience powers eight approved antibody medicines, and the company is advancing\na strong late-stage clinical pipeline, including wholly owned programs, with\nthe goal of delivering transformative medicines to patients.\n\nEstablished in 1999, Genmab is headquartered in Copenhagen, Denmark, with\ninternational presence across North America, Europe and Asia Pacific. For\nmore information, please visit Genmab.com or follow us on LinkedIn\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3D-L61Myomg4CzRnh1GNsJd2D9RTjJ2xQeJph4tvLFd8m6p-6KMYzRKHh8wGaP56a_nKzCa7CQZEyJqPyi1PujT5lQIWhoMKFEveIAZKbWQzM%3D&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=LinkedIn&index=8&md5=d46db30a9e937a31a2a8f8402bc9e4d3)\n, X\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3D-FmdIE15VSb91gaAkFTOKF9jybga5r0ADyADmP3-CMdNn8Q8tYVj-jk6sMYbhNubT_0DplMHzrsbd-OkQMLXqw%3D%3D&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=X&index=9&md5=ee57dee6a4c24a7a3523c356e58b9a99)\n, Facebook\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.facebook.com%2Fshare%2F1DdeiTZ7H4%2F%3Fmibextid%3DwwXIfr&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=Facebook&index=10&md5=99038942cdf2e956474814df2336c73a)\n and Instagram\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.instagram.com%2Fgenmab.biotech%3Figsi%3DcHU4czE2azJkMm01&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=Instagram&index=11&md5=503bf384c1ab308071aa99c619d33f89)\n.\n\nAbout AbbVie in Oncology\n\nAbbVie is committed to elevating standards of care and bringing transformative\ntherapies to patients worldwide living with difficult-to-treat cancers. We are\nadvancing a dynamic pipeline of investigational therapies across a range of\ncancer types in both blood cancers and solid tumors. We are focusing on\ncreating targeted medicines that either impede the reproduction of cancer\ncells or enable their elimination. We achieve this through various, targeted\ntreatment modalities and biology interventions, including small molecule\ntherapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based\ntherapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated\nand experienced team joins forces with innovative partners to accelerate the\ndelivery of potential breakthrough medicines.\n\nToday, our expansive oncology portfolio is comprised of approved and\ninvestigational treatments for a wide range of blood and solid tumors. We are\nevaluating more than 35 investigational medicines across some of the world's\nmost widespread and debilitating cancers. As we work to have a remarkable\nimpact on people's lives, we are committed to exploring solutions to help\npatients obtain access to our cancer medicines. For more information, please\nvisit us at http://www.abbvie.com/oncology\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fedge.prnewswire.com%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4597855-1%26h%3D644583804%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D4200900-1%2526h%253D237160949%2526u%253Dhttps%25253A%25252F%25252Fc212.net%25252Fc%25252Flink%25252F%25253Ft%25253D0%252526l%25253Den%252526o%25253D4183333-1%252526h%25253D396968399%252526u%25253Dhttp%2525253A%2525252F%2525252Fwww.abbvie.com%2525252Foncology%252526a%25253Dhttp%2525253A%2525252F%2525252Fwww.abbvie.com%2525252Foncology%2526a%253Dhttp%25253A%25252F%25252Fwww.abbvie.com%25252Foncology%26a%3Dhttp%253A%252F%252Fwww.abbvie.com%252Foncology&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=http%3A%2F%2Fwww.abbvie.com%2Foncology&index=12&md5=7f5fa041b55d1ddd3546d4ec5db39061)\n.\n\nAbout AbbVie\n\nAbbVie's mission is to discover and deliver innovative medicines and solutions\nthat solve serious health issues today and address the medical challenges of\ntomorrow. We strive to have a remarkable impact on people's lives across\nseveral key therapeutic areas including immunology, neuroscience and oncology\n– and products and services in our Allergan Aesthetics portfolio. For more\ninformation about AbbVie, please visit us at www.abbvie.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.abbvie.com&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=www.abbvie.com&index=13&md5=ea3e2930b2821a9a2309170c600d02dc)\n. Follow @abbvie on LinkedIn\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fabbvie%2F&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=LinkedIn&index=14&md5=c4dcfe322b9b0f063774ecd78076ce0b)\n, Facebook\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.facebook.com%2FAbbVieGlobal%2F&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=Facebook&index=15&md5=0380659c51fdb8a40cc81a37574009ec)\n, Instagram\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.instagram.com%2Fabbvie%2F&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=Instagram&index=16&md5=342602fbea96b60977b3bb520973d47a)\n, X\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Ftwitter.com%2Fabbvie&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=X&index=17&md5=78604862f7d879dfb0007846688b6210)\nand YouTube\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.youtube.com%2Fuser%2FAbbVie&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=YouTube&index=18&md5=490ac3b32a8048ab5edbe79ef6427e11)\n.\n\nGenmab Forward-Looking Statements\n\nThis Company Announcement contains forward looking statements. The words\n“believe,” “expect,” “anticipate,” “intend” and “plan” and\nsimilar expressions identify forward looking statements. Actual results or\nperformance may differ materially from any future results or performance\nexpressed or implied by such statements. The important factors that could\ncause our actual results or performance to differ materially include, among\nothers, risks associated with preclinical and clinical development of\nproducts, uncertainties related to the outcome and conduct of clinical trials\nincluding unforeseen safety issues, uncertainties related to product\nmanufacturing, the lack of market acceptance of our products, our inability to\nmanage growth, the competitive environment in relation to our business area\nand markets, our inability to attract and retain suitably qualified personnel,\nthe unenforceability or lack of protection of our patents and proprietary\nrights, our relationships with affiliated entities, changes and developments\nin technology which may render our products or technologies obsolete, and\nother factors. For a further discussion of these risks, please refer to the\nrisk management sections in Genmab’s most recent financial reports, which\nare available on www.genmab.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DbfzHFRn1Lh91NWWRRYKXR6gMkb0xx1vgslT_nW-gUyJw-N9YMcqzB1NQ3pIp6hNqzxIRmbGbqiaoZyel-soJq-daspA9Jk4KbvHriAZpyy8%3D&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=www.genmab.com&index=19&md5=967720137fcecf1ccab1a86bb8959fa2)\nand the risk factors included in Genmab’s most recent Annual Report on Form\n20-F and other filings with the U.S. Securities and Exchange Commission (SEC),\nwhich are available at www.sec.gov\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DbfzHFRn1Lh91NWWRRYKXR7psSmoozpdjwWBdoMUEzYPiYaxV5Pu72SKSUlk2E-FV-tMObx0NGzgw61AsZUiT5Q%3D%3D&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=www.sec.gov&index=20&md5=a84f3a85dd137e07fa53b2910448a160)\n. Genmab does not undertake any obligation to update or revise forward looking\nstatements in this Company Announcement nor to confirm such statements to\nreflect subsequent events or circumstances after the date made or in relation\nto actual results, unless required by law.\n\nGenmab A/S and/or its subsidiaries own the following trademarks: Genmab(®);\nthe Y-shaped Genmab logo(®); Genmab in combination with the Y-shaped Genmab\nlogo(®); HuMax(®); DuoBody(®); HexaBody(®); DuoHexaBody(®), HexElect(®\n)and KYSO™. EPCORE(®), EPKINLY(®), TEPKINLY(®) and their designs are\ntrademarks of AbbVie Biotechnology Ltd. Dr. Salles has financial interests\nrelated to AbbVie and Genmab.\n\nAbbVie Forward-Looking Statements\n\nSome statements in this news release are, or may be considered,\nforward-looking statements for purposes of the Private Securities Litigation\nReform Act of 1995. The words \"believe,\" \"expect,\" \"anticipate,\" \"project\" and\nsimilar expressions and uses of future or conditional verbs, generally\nidentify forward-looking statements. AbbVie cautions that these\nforward-looking statements are subject to risks and uncertainties that may\ncause actual results to differ materially from those expressed or implied in\nthe forward-looking statements. Such risks and uncertainties include, but are\nnot limited to, challenges to intellectual property, competition from other\nproducts, difficulties inherent in the research and development process,\nadverse litigation or government action, changes to laws and regulations\napplicable to our industry, the impact of global macroeconomic factors, such\nas economic downturns or uncertainty, international conflict, trade disputes\nand tariffs, and other uncertainties and risks associated with global business\noperations. Additional information about the economic, competitive,\ngovernmental, technological and other factors that may affect AbbVie's\noperations is set forth in Item 1A, \"Risk Factors,\" of AbbVie's 2025 Annual\nReport on Form 10-K, which has been filed with the Securities and Exchange\nCommission, as updated by its Quarterly Reports on Form 10-Q and in other\ndocuments that AbbVie subsequently files with the Securities and Exchange\nCommission that update, supplement or supersede such information. AbbVie\nundertakes no obligation, and specifically declines, to release publicly any\nrevisions to forward-looking statements as a result of subsequent events or\ndevelopments, except as required by law.\n\n_______________________________\n\n(i) Lymphoma Research Foundation. Diffuse Large B-Cell Lymphoma. Accessed\nFebruary 2026.\nhttps://lymphoma.org/understanding-lymphoma/aboutlymphoma/nhl/dlbcl/ \n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DpHH_sfAlu8-x7jU2sSUrjQzOj6_c66axXS5GyAZdE6mteO7jJcT9h_cPX0hOJ4TlJyDZezkdGqYwIiz86cSCENY455VeCOfV3tEJ_KqAZ8BtXSfqfZxCsksx3tJ6d8UngYu_0V2qvPJcfF9IyDpaPdS4rilvqRL3od-rdb9GQJ-WTXD3T34URO4358KhAA-keNH4MfG9lDest9CrcribEsLP19cgLDBgjQ8nui_shKs%3D&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=https%3A%2F%2Flymphoma.org%2Funderstanding-lymphoma%2Faboutlymphoma%2Fnhl%2Fdlbcl%2F&index=21&md5=a425175159b43300dd9fe8588e28d7b8)\n\n(ii) Padala, et al. Diffuse Large B-Cell Lymphoma. StatPearls [Internet].\nTreasure Island (FL): StatPearls Publishing; 2024 Jan. 2023 Apr 24.\n\n(iii) Leukemia and Lymphoma Society. Diffuse Large B-Cell Lymphoma (DLBCL).\nAccessed February 2026.\nhttps://www.lls.org/research/diffuse-large-b-cell-lymphoma-dlbcl \n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DpHH_sfAlu8-x7jU2sSUrjWuRrOfMb-_gZ1ZyPeF6ijY-tgZSHq78o2OtkAb0Y1Qwf37n9rKsdWU8qDW1W_syoCU_D_OrLv_u5OMmUskf0_U9SDfvxoFinIUPVZN1LALTlPP5TbdWimE2M-43yPoiJZuoDj2wfyVOXwQQoeKiCly3e8csJB3RIOQZV9F_FIQ82lmHevPB7eDZQKzItLsKYzCAr_kqZoRunBxRZz2DZE5MfuaBntnWJDJCkU9kIYKhZbpYWzKlKmzjAO2rWjXJxkKayj2iXrX1Gau00GBksmDa2ljsA3vL611eF1y2Y_AbuWV9-5NOO9LwXOO49vKkAjHEGcid3ZIMkE4g-dVc8T930mrfiMpjaWKOFkbUXvSqlQTdaOcexNx2Slj8losdeGE1FsRTpPm-uwBkYvrAWUE%3D&esheet=54616407&newsitemid=20261005374420&lan=en-US&anchor=https%3A%2F%2Fwww.lls.org%2Fresearch%2Fdiffuse-large-b-cell-lymphoma-dlbcl&index=22&md5=3aa763631a83c49370906b07ec647c74)\n\n(iv) Sehn, et al. Diffuse Large B-Cell Lymphoma. N Engl J Med.\n2021;384:842-858. doi: 10.1056/NEJMra2027612.\n\n(v) Kanas, et al. Epidemiology of Diffuse Large B-Cell Lymphoma (DLBCL) and\nFollicular Lymphoma (FL) in the United States and Western Europe:\nPopulation-Level Projections for 2020-2025. Leuk Lymphoma. 2022;63(1):54-63.\ndoi: 10.1080/10428194.2021.1975188.\n\n(vi) Crump, et al. Outcomes in Refractory Diffuse Large B-Cell Lymphoma:\nResults From the International SCHOLAR-1 Study. Blood. 2017;130(16):1800-1808.\ndoi: 10.1182/blood-2017-03-769620.\n\n(vii) Engelberts PJ, Hiemstra IH, de Jong B, et al. DuoBody-CD3xCD20 induces\npotent T-cell-mediated killing of malignant B cells in preclinical models and\nprovides opportunities for subcutaneous dosing. EBioMedicine. 2020;52:102625.\nDOI: 10.1016/j.ebiom.2019.102625.\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20261005374420/en/\n(https://www.businesswire.com/news/home/20261005374420/en/)\n\nGenmab Contacts: \n\nMarisol Peron, Senior Vice President, Global Communications & Corporate\nAffairs\n\nT: +1 609 524 0065; E: mmp@genmab.com (mailto:mmp@genmab.com)\n\nAndrew Carlsen, Vice President, Head of Investor Relations\n\nT: +45 3377 9558; E: acn@genmab.com (mailto:acn@genmab.com)\n\nAbbVie Contacts: \n\nRaquel Powers, Director, Oncology Public Affairs\n\nT: +1 847 935 6563; E: raquel.powers@abbvie.com\n(mailto:raquel.powers@abbvie.com)\n\nTodd Bosse, Vice President, Investor Relations\n\nT: +1 847-936-1182; E: todd.bosse@abbvie.com (mailto:todd.bosse@abbvie.com)\n\n\nCopyright Business Wire 2026"},"type":"article","timestamp":"2026-10-05T18:50:00.155720554Z","server_sent_at_ms":1791226200155},"received_at":"2026-10-05T18:50:00.311Z","source_url":"https://www.businesswire.com/news/home/20261005374420/en/"},"analysis":null,"durationMs":null,"modelName":null}}