Tafasitamab-Cxix

iStock, Bo Shen The FDA also approved the use of Zynyz as a monotherapy for patients with squamous cell carcinoma of the anal canal who are intolerant to platinum chemotherapy or whose disease has progressed. Incyte on Thursday successfully expanded the label of its cancer therapy Zynyz, opening up its use as a first-line therapy for patients with squamous cell carcinoma of the anal canal. Zynyz, first approved in 2023 for metastatic, recurrent or locally advanced Merkel cell carcinoma, is an intravenous PD-1 inhibitor that forms a substantial part of Incyte’s cancer portfolio. In an April 29 note to investors, in reaction to the company’s Q1 results, analysts at Truist noted that Zynyz—alongside the lymphoma drug Monjuvi—will help account for the company’s 2025 oncology sales forecast of $415 million to $455 million. Thursday’s approval covers the use of Zynyz in combination with carboplatin and paclitaxel as a frontline treatment option for patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). The FDA also signed off on Zynyz as a monotherapy for patients whose disease has progressed or who are otherwise intolerant to platinum-based chemotherapy. The expansion snatched victory from the jaws of defeat, as the FDA rejected Zynyz in SCAC in 2021. In a note Friday morning, Leerink Partners wrote that “Zynyz + chemo demonstrated a clear benefit over 1L standard of care carboplatin–paclitaxel...likely helping to dispel former FDA concerns on the efficacy profile.” The approval is a “pivotal moment” for the SCAC space, CEO Hervé Hoppenot said, “bringing effective combination and monotherapy treatment options.” Zynyz is the first PD-1 blocker in the U.S. to be approved for the indication, according to Hoppenot. Backing Zynyz’s approval are data from the Phase III POD1UM-303 trial. Incyte presented results from this study at the September 2024 European Society of Medical Oncology (ESMO) meeting, touting a 37% reduction in the risk of disease progression or death in patients treated with Zynyz plus a platinum-based chemotherapy regimen versus chemotherapy alone. Incyte at the time called this effect “clinically meaningful.” The ESMO readout also demonstrated improvements in overall survival and overall response rates in patients treated with the Zynyz combo. Incyte is also seeking approval for Zynyz in SCAC in the European Union and Japan. Zynyz’s label expansion comes weeks after Incyte announced Q1 earnings that William Blair labeled “solid” in an April 29 note. The company made $1.053 billion in the quarter, a 20% year-on-year increase and a comfortable beat over the $990 million consensus expectation. Jakafi, a kinase inhibitor, remained Incyte’s strongest asset. The drug brought in $709 million in Q1, which surpassed the $643 analyst estimate. With this strong start to the year, the company raised its full-year guidance for the drug from $2.95 billion to $3 billion. Incyte’s heavy reliance on Jakafi, however, is double-edged, according to William Blair. “While we believe that Jakafi remains the best-in-class therapy in some approved indications, there is emerging competition and potential for a novel therapy to take market share,” the analysts wrote. Competition and impending loss of exclusivity—key patents are expected to expire in late 2028—are “ongoing concerns,” as per William Blair.

Media ReleaseCOPENHAGEN, Denmark; May 14, 2025 Data from 14 abstracts highlight the depth, breadth, and strength of Genmab’s comprehensive epcoritamab development program across multiple patient populations and treatment settings Genmab A/S (Nasdaq: GMAB) announced today that it will present 14 abstracts evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy and in combination across disease settings in patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) at the 30th European Hematology Association (EHA) Congress, being held in Milan, Italy, and virtually, June 12-15, 2025. Two oral presentations will feature data from the Phase 1/2 EPCORE® NHL-2 trial evaluating epcoritamab plus rituximab and ifosfamide-carboplatin-etoposide (R-ICE) in patients with relapsed/refractory (R/R) DLBCL eligible for autologous stem cell transplantation, and the Phase 1/2 EPCORE NHL-5 trial evaluating epcoritamab plus polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R-CHP) in previously-untreated patients with DLBCL. Additionally, results from the Phase 1/2 EPCORE NHL-1 and NHL-3 trials, including three years of follow-up in patients with R/R DLBCL and FL treated with epcoritamab monotherapy, will be presented as a poster. All abstracts accepted for presentation have been published and may be accessed online via the EHA Open Access Library. “Together with AbbVie, we have made tremendous progress advancing our broad epcoritamab development program and we are pleased to share important results at EHA 2025 evaluating epcoritamab in a variety of treatment settings and patient populations,” said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. “The data presented at EHA further reinforce our commitment to epcoritamab and its potential to become a core therapy across B-cell malignancies.” Several abstracts evaluating epcoritamab will also be presented at the 18th International Conference on Malignant Lymphoma (ICML), taking place June 17-21, 2025, in Lugano, Switzerland. Abstracts accepted for presentation at EHA include: Abstract Number Abstract Title Type of Presentation Date/Time of Presentation S245First Disclosure of Epcoritamab + R-ICE in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL) Eligible for Autologous Stem Cell Transplantation (ASCT): EPCORE NHL-2OralSunday, June 1511:00-12:15 CESTS247Durable Efficacy with Fixed-Duration Epcoritamab + Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) for 1L Diffuse Large B-cell Lymphoma (EPCORE NHL-5)OralSunday, June 1511:00-12:15 CESTPF881Epcoritamab Monotherapy Demonstrates Deep and Durable Responses at Three-Year follow-up in Patients with Relapsed/Refractory Follicular LymphomaPosterFriday, June 13 18:30-19:30 CESTPF885Epcoritamab Plus Lenalidomide and Rituximab Achieves High Response Rates and Survival Benefits Compared with Usual Care in Relapsed/Refractory Follicular Lymphoma: A Comparative AnalysisPosterFriday, June 13 18:30-19:30 CESTPF920Sustained Remission in R/R DLBCL with Epcoritamab Monotherapy: EPCORE NHL-1 3y Results and Novel Subgroup Analyses in Patients with Complete Response at 2yPosterFriday, June 13 18:30-19:30 CESTPS1886Matching-Adjusted Indirect Comparison of Epcoritamab with Rituximab + Lenalidomide vs Tafasitamab with Rituximab + Lenalidomide in Second-Line+ Follicular LymphomaPosterSaturday, June 14 18:30-19:30 CESTPS1898Patient-Reported Outcomes in Patients with Relapsed/Refractory Follicular Lymphoma Treated with Epcoritamab within the Entire Study Cohort and in Patients with Symptoms at BaselinePosterSaturday, June 14 18:30-19:30 CESTPS1968Match-Adjusted Comparative Analysis of Epcoritamab + R-DHAX/C or R-ICE vs R-DHAX/C or R-ICE In 2L+ Transplant-Eligible Patients with Diffuse Large B-Cell LymphomaPosterSaturday, June 14 18:30-19:30 CESTPS1942Match-Adjusted Comparative Analysis of the Efficacy Of Epcoritamab + R-Mini-CHOP vs R-Mini-CHOP in Previously Untreated Diffuse Large B-Cell LymphomaPosterSaturday, June 14 18:30-19:30 CESTPS1932Treatment Outcomes in Newly Diagnosed Diffuse Large B-Cell Lymphoma Patients with High Cardiovascular Risk, and Treated with Non-Anthracycline Containing RegimensPosterSaturday, June 14 18:30-19:30 CESTPS1944Patient Preferences for Attributes of Bispecific Antibodies Indicated for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma in the United StatesPosterSaturday, June 14 18:30-19:30 CESTPS1912Circulating Tumour DNA-Directed Intervention with Epcoritamab Alone or in Combination with Lenalidomide and Rituximab is Feasible in the Early Post-CAR-T Population at High Risk of Relapse: Preliminary Data from EpLCARTPosterSaturday, June 14 18:30-19:30 CESTPS1979Epcoritamab with Gemcitabine, Dexamethasone, and Cisplatin (Epco-GDP) in Relapsed, Refractory Large B-cell Lymphoma – An Interim Analysis of Phase II Multicenter Investigator-initiated TrialPosterSaturday, June 1415:30-16:00 CESTPS1892Phase II Investigator-initiated Trial of Epcoritamab-Lenalidomide in Treatment Naïve Follicular LymphomaPosterSaturday, June 14 18:30-19:30 CEST The safety and efficacy of these investigational uses have not been established. About Epcoritamab Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody® technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.i Epcoritamab (approved under the brand name EPKINLY® in the U.S. and Japan, and TEPKINLY® in the EU) has received regulatory approval in certain lymphoma indications in several territories. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication. Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes five ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy (NCT04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with R/R FL (NCT05409066), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744), and a trial evaluating epcoritamab in combination with lenalidomide compared to chemoimmunotherapy in patients with R/R DLBCL (NCT06508658). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information. About Genmab Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For more than 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO) antibody medicines®.  Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X. Contact: David Freundel, Senior Director, Product CommunicationsT: +1 609 613 0504; E: dafr@genmab.com Andrew Carlsen, Vice President, Head of Investor RelationsT: +45 3377 9558; E: acn@genmab.comThis Media Release contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody®, HexElect® and KYSO®. EPCORE®, EPKINLY®, TEPKINLY® and their designs are trademarks of AbbVie Biotechnology Ltd. i Engelberts PJ, et al. DuoBody-CD3xCD20 Induces Potent T-Cell-Mediated Killing of Malignant B Cells in Preclinical Models and Provides Opportunities for Subcutaneous Dosing. EBioMedicine. 2020;52:102625. doi: 10.1016/j.ebiom.2019.102625. Media Release no. i08CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122 Genmab A/SCarl Jacobsens Vej 302500 ValbyDenmark Attachment 140525_MRi08_EHA Curtain Raiser