Delving into the Latest Updates on Petosemtamab with Synapse

Overview

Basic Info

Drug Type

Bispecific antibody

Synonyms

GEN-1158, MCLA-158, MCLA158

Target

EGFR x LGR5

Action

antagonists

Mechanism

EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), LGR5 antagonists(Leucine-rich repeat-containing G-protein coupled receptor 5 antagonists)

Therapeutic Areas

NeoplasmsDigestive System DisordersRespiratory Diseases

Active Indication

Recurrent Squamous Cell Carcinoma of the Head and NeckSquamous cell carcinoma of head and neck metastaticAdvanced Malignant Solid Neoplasm+ [5]

Inactive Indication

metastatic non-small cell lung cancerNon-squamous non-small cell lung cancer

Originator Organization

Merus NV

Active Organization

Merus NV

Inactive Organization-

License Organization

Merus NV

Halozyme Therapeutics, Inc.

Drug Highest PhasePhase 3

First Approval Date-

RegulationBreakthrough Therapy (United States), Fast Track (United States)

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Structure/Sequence

Sequence Code 43197L

Source: *****

Sequence Code 616716061H

Source: *****

Sequence Code 775236079H

Source: *****

The Antibodies to Watch article series provides annual updates on commercial late-stage clinical development, regulatory review, and marketing approvals of antibody therapeutics. Since the first article was published in 2010, the late-stage pipeline has grown from 26 antibody therapeutics to over 200, while during the same time numerous molecules in late-stage studies either transitioned to regulatory review and were approved or were terminated. In this installment of the series, we recap first marketing approvals granted to 19 antibody therapeutics in 2025, discuss 26 molecules currently in regulatory review, including the bispecific antibody-drug conjugate izalontamab brengitecan, and predict which molecules of the 209 currently in the commercial late-stage pipeline might transition to regulatory review by the end of 2026. Most antibody therapeutics in the latter category are for non-cancer indications (16/21, 76%) and have a conventional format (13/21, 62%), but the category also includes numerous antibody-oligo or -drug conjugates, such as delpacibart etedesiran, delpacibart zotadirsen, zeleciment rostudirsen, sonesitatug vedotin, trastuzumab pamirtecan, and ifinatamab deruxtecan, as well as the bispecific petosemtamab. As antibody therapeutics development is a global enterprise, we also discuss trends in annual first approvals granted to antibody therapeutics in any country since 2010, stratified by the antibody's country of origin, documenting the notable increases in the total number of first approvals and those approved first in China. Finally, to benchmark the time typically required for clinical development and regulatory review, we calculated this period for recently approved antibody therapeutic products stratified by their therapeutic area, mechanism of action, format, and country of origin. Our data show that the development and approval period were typically ~6 years, but on average this period was shorter for China-originated products.

01 Aug 2026·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Immunotherapeutic strategies in HPV-positive and HPV-negative recurrent/metastatic oropharyngeal squamous cell carcinoma: From PD-1 blockade to EGFR-directed bispecifics and therapeutic HPV vaccines

Review

Author: Del Mastro, Lucia ; Gili, Riccardo ; Di Bello, Armando ; Caterino, Marianna ; Cassano, Alessandra ; Bassolino, Antonio ; Fasano, Morena ; Polidori, Sara ; Falcicchia, Renato ; Tortora, Giampaolo

Oropharyngeal squamous cell carcinoma (OPSCC) comprises two biologically distinct entities, HPV-positive and HPV-negative disease, which differ in etiology, immune microenvironment, molecular drivers, and clinical behavior. This narrative review summarizes current evidence on immunotherapeutic strategies in OPSCC, focusing on subtype-specific biological rationale and emerging treatment approaches. A literature search of PubMed/MEDLINE, Embase, Cochrane Library, ClinicalTrials.gov, and major oncology meeting abstracts was conducted for studies published from January 2000 to February 2026. PD-1/PD-L1 inhibitors represent the current standard of care in recurrent/metastatic disease, with HPV-positive tumors generally showing more favorable outcomes, likely reflecting a more inflamed and antigen-rich tumor microenvironment. However, HPV status remains primarily a prognostic rather than a validated predictive biomarker for checkpoint inhibitor benefit. In contrast, HPV-negative OPSCC is more frequently characterized by immune exclusion, EGFR dependence, hypoxia, and activation of MET/HGF and TGF-β pathways, supporting the development of EGFR-centered and bifunctional strategies to overcome resistance. Emerging agents such as ficerafusp alfa, petosemtamab, and amivantamab have demonstrated promising early clinical activity, particularly in biomarker-enriched or post-immunotherapy settings. In HPV-positive disease, therapeutic vaccines targeting E6/E7 oncoproteins have shown encouraging immunogenicity and preliminary antitumor activity, especially when combined with PD-1 blockade. Overall, the immunotherapeutic landscape of OPSCC is evolving toward a biomarker-driven framework integrating viral status, immune contexture and pathway activation to enable more precise and personalized treatment strategies.

01 May 2026·CURRENT OPINION IN ONCOLOGY

Recent highlights and breakthroughs in immunotherapy for head and neck cancers

Review

Author: Vuille, Joanna A ; Szturz, Petr

Purpose of review:

This review highlights recent advances in immunotherapy for head and neck oncology, focusing on pivotal studies, both early-stage and late-stage, published or presented in 2025.

Recent findings:

Noteworthy results were reported with immune checkpoint inhibitors in mucosal squamous cell carcinoma of the head and neck (SCCHN) (KEYNOTE-689 and NIVOPOSTOP trials evaluating pembrolizumab and nivolumab, respectively, in the perioperative setting); in nasopharyngeal carcinoma (DIPPER and DIAMOND trials evaluating camrelizumab and toripalimab, respectively, in the curative setting with radiotherapy, and tagitanlimab in recurrent and/or metastatic disease); in cutaneous squamous cell carcinoma of the head and neck region (C-POST trial in the adjuvant setting and the combination of avelumab with cetuximab in the palliative setting); and in BRAF V600E-mutated anaplastic thyroid carcinoma (pembrolizumab with dabrafenib and trametinib). Passive immunotherapy targeting tumor-associated antigens also showed encouraging activity in R/M-SCCHN (petosemtamab, ficerafusp-alfa, amivantamab, enfortumab vedotin) and in heavily pretreated R/M nasopharyngeal carcinoma (antibody-drug conjugates becotatug vedotin and izalontamab brengitecan [iza-bren]).

Summary:

Recent advances highlight a rapid surge in positive immunotherapy trials across different head and neck cancer entities, with clinical benefit observed both when immune checkpoint inhibitors are moved earlier in the disease course and when they are combined with agents targeting resistance mechanisms or enabling more precise drug delivery to tumors.

94

News (Medical) associated with Petosemtamab

26 May 2026

·www.biospace.com

Genmab to Highlight Advances Across Its Oncology Portfolio at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) 2026 Congress

Media Release COPENHAGEN, Denmark; May 21, 2026 Twenty-three abstracts will highlight the versatility and strength of Genmab’s portfolio and pipeline, including data from the comprehensive epcoritamab development program, including 4 oral presentations Three abstracts will show the ongoing clinical trial evaluations of the safety and efficacy of Genmab’s investigational late-stage medicines, rinatabart sesutecan and petosemtamab Data evaluating epcoritamab will demonstrate outcomes across monotherapy, combination regimens and fixed-duration use, including outpatient administration and use in earlier lines of treatment Genmab A/S (Nasdaq: GMAB ) announced today that 23 abstracts, including 20 abstracts evaluating epcoritamab, a subcutaneous T-cell engaging bispecific antibody, will be presented or published at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL, from May 29-June 2, and at the European Hematology Association (EHA) 2026 Congress in Stockholm, Sweden, from June 11-14. Key presentations at ASCO and EHA will highlight data evaluating the potential utility of epcoritamab across multiple settings, including as a monotherapy, in combination regimens, in fixed-duration use and in earlier lines of therapy. Oral sessions will feature the first presentation of the full results from the Phase 3 EPCORE ® DLBCL-1 trial comparing epcoritamab monotherapy to investigator’s choice chemotherapy in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL), as well as additional data from the Phase 3 EPCORE ® FL-1 trial evaluating epcoritamab in combination with rituximab and lenalidomide (R 2 ) versus R 2 alone in patients with R/R follicular lymphoma (FL). Additional presentations will include real-world evidence and health economic and outcomes research data, as well as overviews of trials-in-progress evaluating late-stage medicines. “This year at ASCO and EHA, Genmab will once again present data highlighting the depth and breadth of the epcoritamab development program, including encouraging results across multiple treatment settings for patients with B-cell malignancies. These findings underscore the versatility of epcoritamab as a monotherapy, in combination regimens and as a potential core therapy across the spectrum of B-cell malignancies,” said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. “Additional presentations and publications at ASCO will further reflect our commitment to advancing other antibody-based therapeutics.” All abstracts accepted for presentation and publication have been published and may be accessed online via the ASCO Meeting Library and EHA Open Access Library . Abstracts accepted for presentation at ASCO: Epcoritamab: Abstract Number Abstract Title Type of Presentation Date/Time of Presentation 7002* Phase 2 trial of epcoritamab in combination with rituximab-mini CVP for older unfit/frail or anthracycline-ineligible adult patients with newly diagnosed diffuse large B-cell lymphoma: Interim futility analysis Oral presentation Saturday, May 30, 3:00 PM-6:00 PM CDT 7061 Epcoritamab (epcor) + chemoimmunotherapy (CIT) in patients (pts) with relapsed/refractory large B cell lymphoma (R/R LBCL) eligible for autologous stem cell transplant (ASCT): Pooled results from Arms 4 and 10 of EPCORE NHL-2 Poster Monday, June 1, 9:00 AM-12:00 PM CDT e19003 NHL-6: Phase 2 study of subcutaneous (SC) epcoritamab as outpatient treatment for 2L+ relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) Publication Only NA *Investigator-led trial Rinatabart sesutecan (Rina-S ® ): Abstract Number Abstract Title Type of Presentation Date/Time of Presentation TPS5646 RAINFOL-03 (ENGOT-EN-31/GOG-3128): A phase 3, open-label, randomized study of Rinatabart sesutecan vs investigator’s choice of chemotherapy in patients with endometrial cancer after platinum-based chemotherapy and programmed death ligand 1 inhibition Poster Monday, June 1, 9:00 AM-12:00 PM CDT TPS5641 RAINFOL-04 (ENGOT-OV96/GOG-3134): A phase 3, open-label, randomized study of Rinatabart sesutecan plus standard of care (SOC) vs SOC as maintenance treatment after second-line platinum-based chemotherapy in patients with recurrent platinum-sensitive ovarian cancer Poster Monday, June 1, 9:00 AM-12:00 PM CDT Petosemtamab: Abstract Number Abstract Title Type of Presentation Date/Time of Presentation TPS8662 Petosemtamab plus pembrolizumab as first-line (1L) treatment of PD-L1 high metastatic non-small cell lung cancer (NSCLC): Global phase 2 trial Poster Sunday, May 31, 9:00 AM-12:00 PM CDT Abstracts accepted for presentation at EHA: Epcoritamab: Abstract Number Abstract Title Type of Presentation Date/Time of Presentation S229 Clinically Relevant Subgroup Analysis from the Randomized Phase 3 EPCORE FL-1 Trial: Treatment (Tx) Effect of Epcoritamab with Lenalidomide and Rituximab (R2) in R/R Follicular Lymphoma (FL) Oral Presentation Thursday, June 11, 16:45-18:00 CEST S235 Results From EPCORE DLBCL-1: Randomized Phase 3 Study of Epcoritamab (Epcor) Vs Investigator’s Choice Chemoimmunotherapy (CIT) in Patients with Relapsed/Refractory Large B-cell Lymphoma (R/R LBCL) Oral Presentation Friday, June 12, 17:15-18:30 CEST S153* Fixed Duration Venetoclax Plus Epcoritamab Shows Favorable Tolerability and High Response Rates with Early Molecular Responses in R/R CLL/SLL: Interim Analysis of the Randomized HOVON 165/AETHER Trial Oral Presentation Sunday June 14, 11:00-12:15 CEST *Investigator-led trial PF977 Sustained Remissions Beyond 4 Years with Epcoritamab Monotherapy: Long-term Follow-up Results from the Pivotal EPCORE NHL-1 Trial in Patients with Relapsed or Refractory Large B-cell Lymphoma Poster Friday, June 12, 18:45-19:45 CEST PF1007 Epcoritamab + R-mini-chop Results in 2-year Remissions and High MRD-negativity Rates in Elderly Patients with Newly Diagnosed DLBCL: Results from the EPCORE NHL-2 Trial Poster Friday, June 12, 18;45-19:45 CEST PF1069 Reduced CD20 Expression and Intratumoral CD3+ T Cells Following Epcoritamab Treatment Are Associated with Progressive Disease in a Subset of Diffuse Large B-cell Lymphoma and Follicular Lymphoma Poster Friday, June 12, 18:45-19:45 CEST PF1081 Pharmacodynamic Biomarkers Support the Clinical Benefit of Epcoritamab Plus Rituximab and Lenalidomide (R2) in Patients with Relapsed/Refractory Follicular Lymphoma (R/R FL): Analyses from EPCORE FL-1 Poster Friday, June 12, 18:45-19:45 CEST PS2035 Anchored Matching-adjusted Indirect Comparison of Epcoritamab, Lenalidomide, and Rituximab Vs Tafasitamab, Lenalidomide, and Rituximab in Relapsed/Refractory Follicular Lymphoma: EPCORE FL-1 Vs Inmind Poster Saturday, June 13, 18:45-19:45 CEST PS2042 Comparative Effectiveness of Epcoritamab, Lenalidomide, and Rituximab in EPCORE FL-1 Vs Real-world Chemoimmunotherapy in Relapsed/Refractory Lymphoma Poster Saturday, June 13, 18:45-19:45 CEST PS2052 Comparative Analyses of Epcoritamab in Combination with Lenalidomide and Rituximab Vs Obinutuzumab and Bendamustine in Relapsed/Refractory Follicular Lymphoma Poster Saturday, June 13, 18:45-19:45 CEST PS2070 Epcoritamab + Chemoimmunotherapy in Patients with Relapsed/Refractory Large B-cell Lymphoma Eligible for Autologous Stem Cell Transplant: Pooled Results from Arms 4 And 10 of EPCORE NHL-2 Poster Saturday, June 13, 18:45-19:45 CEST PS2082 Fixed-duration Epcoritamab Monotherapy Induces High Response and MRD-negativity Rates in Elderly Patients with Newly Diagnosed Large B-cell Lymphoma and Comorbidities: Results from EPCORE DLBCL-3 Poster Saturday, June 13, 18:45-19:45 CEST PS2086 Epcoritamab in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL): Insights from the Real-world Epcoritamab Patient Characteristics and Outcomes Research (Real-epcor) Study Poster Saturday, June 13, 18:45-19:45 CEST PS2497 Epcoritamab Plus Lenalidomide and Rituximab Improves or Preserves Health-related Quality of Life in Patients with Relapsed/Refractory Follicular Lymphoma Who Had High Symptom Burden or Adverse Events Poster Saturday, June 13, 18:45-19:45 CEST NA Epcoreal: A Prospective Observational Trial-in-progress of Epcoritamab in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma and Follicular Lymphoma Publication Only NA NA Epcoritamab With Lenalidomide and Rituximab in Chinese Patients with Relapsed or Refractory Follicular Lymphoma: A Subgroup Analysis from the Phase 3 Epcore FL-1 Trial Publication Only NA NA Cost Per Complete Responder for Epcoritamab + Lenalidomide and Rituximab (R2) Vs Tafasitamab + R2 in Relapsed or Refractory Follicular Lymphoma: A US Medicare Perspective Publication Only NA The safety and efficacy of epcoritamab, Rina-S and petosemtamab have not been established for these investigational uses. 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 epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes several ongoing Phase 3, open-label, randomized trials, among them a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL ( NCT05578976 ), a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL ( NCT06508658 ), and a trial evaluating epcoritamab in combination with lenalidomide and rituximab (R 2 ) compared to chemoimmunotherapy in patients with previously untreated FL ( NCT06191744 ). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit for more information. Please see local country prescribing information for all labeled indication and safety information. About Rinatabart Sesutecan (Rina-S; GEN1184 ) Rina-S; GEN1184 is an investigational ADC. It is composed of a novel human monoclonal antibody directed at FRα, a hydrophilic protease-cleavable linker, and exatecan, a topoisomerase I inhibitor payload. The clinical development program for Rina-S continues to expand, with multiple ongoing Phase 3 studies in patients with ovarian and endometrial cancer, alongside evaluation in other tumor types with unmet needs. The safety and efficacy of rinatabart sesutecan have not been established. Please visit for more information. About Petosemtamab (GEN1158) Petosemtamab is an investigational bispecific antibody targeting the epidermal growth factor receptor (EGFR) and the leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5). By engaging both receptors, petosemtamab is designed to inhibit EGFR signaling and trigger EGFR degradation selectively in LGR5+ cancer stem-like cells to support multiple anti-tumor mechanisms, including enhanced immune-mediated activity. It is currently being investigated in head and neck squamous cell carcinoma (HNSCC) and other solid tumors, including colorectal cancer (CRC) and non-small cell lung cancer (NSCLC). The safety and efficacy of petosemtamab have not been established. Please visit for more information. About Genmab Genmab is an international biotechnology company dedicated to improving the lives of people with cancer and other serious diseases through innovative antibody medicines. For over 25 years, its passionate, innovative and collaborative team has advanced a broad range of antibody-based therapeutic formats, including bispecific antibodies, antibody–drug conjugates (ADCs), immune-modulating antibodies and other next-generation modalities. Genmab’s science powers eight approved antibody medicines, and the company is advancing a strong late-stage clinical pipeline, including wholly owned programs, with the goal of delivering transformative medicines to patients. 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, Global Communications & Corporate Affairs T: +1 609 613 0504; E: dafr@genmab.com Andrew Carlsen, Vice President, Head of Investor Relations T: +45 3377 9558; E: acn@genmab.com This Media Release contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on 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 . 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. RAINFOL™ and Rina-S® are trademarks of ProfoundBio, U.S., Co. and Genmab (Suzhou) Co., Ltd. i Engelberts PJ, Hiemstra IH, de Jong B, 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. 06 CVR no. 2102 3884 LEI Code 529900MTJPDPE4MHJ122 Genmab A/S Carl Jacobsens Vej 30 2500 Valby Denmark Attachment 052126_MR_06_ASCO_EHA 2026

Phase 3ImmunotherapyPhase 2ASCODrug Approval

21 May 2026

·ir.genmab.com

Genmab to Highlight Advances Across Its Oncology Portfolio at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) 2026 Congress

Media ReleaseCOPENHAGEN, Denmark; May 21, 2026 Twenty-three abstracts will highlight the versatility and strength of Genmab’s portfolio and pipeline, including data from the comprehensive epcoritamab development program, including 4 oral presentations Three abstracts will show the ongoing clinical trial evaluations of the safety and efficacy of Genmab’s investigational late-stage medicines, rinatabart sesutecan and petosemtamab Data evaluating epcoritamab will demonstrate outcomes across monotherapy, combination regimens and fixed-duration use, including outpatient administration and use in earlier lines of treatment Genmab A/S (Nasdaq: GMAB) announced today that 23 abstracts, including 20 abstracts evaluating epcoritamab, a subcutaneous T-cell engaging bispecific antibody, will be presented or published at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL, from May 29-June 2, and at the European Hematology Association (EHA) 2026 Congress in Stockholm, Sweden, from June 11-14. Key presentations at ASCO and EHA will highlight data evaluating the potential utility of epcoritamab across multiple settings, including as a monotherapy, in combination regimens, in fixed-duration use and in earlier lines of therapy. Oral sessions will feature the first presentation of the full results from the Phase 3 EPCORE® DLBCL-1 trial comparing epcoritamab monotherapy to investigator’s choice chemotherapy in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL), as well as additional data from the Phase 3 EPCORE® FL-1 trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) versus R2 alone in patients with R/R follicular lymphoma (FL). Additional presentations will include real-world evidence and health economic and outcomes research data, as well as overviews of trials-in-progress evaluating late-stage medicines. “This year at ASCO and EHA, Genmab will once again present data highlighting the depth and breadth of the epcoritamab development program, including encouraging results across multiple treatment settings for patients with B-cell malignancies. These findings underscore the versatility of epcoritamab as a monotherapy, in combination regimens and as a potential core therapy across the spectrum of B-cell malignancies,” said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. “Additional presentations and publications at ASCO will further reflect our commitment to advancing other antibody-based therapeutics.” All abstracts accepted for presentation and publication have been published and may be accessed online via the ASCO Meeting Library and EHA Open Access Library. Abstracts accepted for presentation at ASCO: Epcoritamab: *Investigator-led trial Rinatabart sesutecan (Rina-S®): Petosemtamab: Abstracts accepted for presentation at EHA: Epcoritamab: *Investigator-led trial The safety and efficacy of epcoritamab, Rina-S and petosemtamab have not been established for these investigational uses. 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 epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes several ongoing Phase 3, open-label, randomized trials, among them a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658), and a trial evaluating epcoritamab in combination with lenalidomide and rituximab (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information. Please see local country prescribing information for all labeled indication and safety information. About Rinatabart Sesutecan (Rina-S; GEN1184)Rina-S; GEN1184 is an investigational ADC. It is composed of a novel human monoclonal antibody directed at FRα, a hydrophilic protease-cleavable linker, and exatecan, a topoisomerase I inhibitor payload. The clinical development program for Rina-S continues to expand, with multiple ongoing Phase 3 studies in patients with ovarian and endometrial cancer, alongside evaluation in other tumor types with unmet needs. The safety and efficacy of rinatabart sesutecan have not been established. Please visit https://clinicaltrials.gov/ for more information. About Petosemtamab (GEN1158)Petosemtamab is an investigational bispecific antibody targeting the epidermal growth factor receptor (EGFR) and the leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5). By engaging both receptors, petosemtamab is designed to inhibit EGFR signaling and trigger EGFR degradation selectively in LGR5+ cancer stem-like cells to support multiple anti-tumor mechanisms, including enhanced immune-mediated activity. It is currently being investigated in head and neck squamous cell carcinoma (HNSCC) and other solid tumors, including colorectal cancer (CRC) and non-small cell lung cancer (NSCLC). The safety and efficacy of petosemtamab have not been established. Please visit https://clinicaltrials.gov/ for more information. About Genmab Genmab is an international biotechnology company dedicated to improving the lives of people with cancer and other serious diseases through innovative antibody medicines. For over 25 years, its passionate, innovative and collaborative team has advanced a broad range of antibody-based therapeutic formats, including bispecific antibodies, antibody–drug conjugates (ADCs), immune-modulating antibodies and other next-generation modalities. Genmab’s science powers eight approved antibody medicines, and the company is advancing a strong late-stage clinical pipeline, including wholly owned programs, with the goal of delivering transformative medicines to patients. 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, Global Communications & Corporate AffairsT: +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. RAINFOL™ and Rina-S® are trademarks of ProfoundBio, U.S., Co. and Genmab (Suzhou) Co., Ltd. i Engelberts PJ, Hiemstra IH, de Jong B, 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. 06CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122 Genmab A/SCarl Jacobsens Vej 302500 ValbyDenmark Attachment 052126_MR_06_ASCO_EHA 2026

ImmunotherapyPhase 3Drug ApprovalASCO

19 May 2026

·www.biospace.com

ATB Therapeutics Appoints Mark Throsby as CEO to Lead Next Phase of Growth

GHENT, Belgium & MARCHE-EN-FAMENNE, Belgium--(BUSINESS WIRE)-- #adcs --ATB Therapeutics (“ATB” or the “Company”), a biopharmaceutical company advancing next-generation antibody-based therapies for oncology and immunology, today announced the appointment of Mark Throsby, PhD , as Chief Executive Officer . The leadership transition marks an important milestone as the Company continues its evolution from a startup into a development-stage biopharmaceutical company. Mark Throsby has served as Executive Chairman and Chief Scientific Officer since 2024, during which time he supported the Company’s growth, including the successful closing of its Series A financing, the expansion of the scientific team, and the advancement of its therapeutic programs. In his new role, he will lead ATB’s strategy and senior leadership team as the Company prepares to enter clinical development. As part of this transition, co-founder Bertrand Magy will move into the role of Chief Operating Officer, and co-founder Max Houry will assume the role of Chief Business Officer. Mr. Magy will focus on operations and the continued development of ATB’s proprietary antibody weaponization technology platform, while Mr. Houry will lead business development, strategic partnerships, and licensing activities. This leadership transition supports ATB’s next stage of growth, with a focus on the validation of ATB’s platform and preparing for clinical development. Mark Throsby, PhD, Chief Executive Officer of ATB Therapeutics, said: “Since the closing of our EUR 54 million Series A financing in 2024, we have made strong progress in strengthening our team, expanding our capabilities, and validating our science. I am honored to take on the role of CEO and excited to continue working closely with Bertrand, Max, the Board, and the broader ATB team as we advance our mission and bring atbodies closer to patients.” Bertrand Magy, PhD, co-founder of ATB Therapeutics, said: “From the beginning, ATB has been driven by a shared vision to create a new class of therapies with real patient impact. It has been an extraordinary scientific and entrepreneurial journey, and I am very proud of what we have accomplished so far. I look forward to continuing to work closely with Mark, Max, and the team as we enter this next chapter.” Max Houry, co-founder of ATB Therapeutics, said: “Over the past years, we have transformed an initial scientific concept into a promising therapeutic platform. Together with Bertrand and Mark, we have built strong foundations for the Company’s future. In my new role, I will focus on translating that momentum into strategic partnerships and business opportunities that can help bring meaningful therapies to patients.” Mark Throsby earned his PhD in Immunology from Monash University in Melbourne, Australia, and spent four years as a research fellow at CNRS in Paris. He began his industry career at Crucell (acquired by Johnson & Johnson for USD 2.4 billion), where he spent eight years in various roles, including Director of Antibody Discovery. Prior to joining ATB, he served at Merus (acquired by Genmab for USD 8.0 billion) as COO and later CSO, where he played a key role in the development of the bispecific antibody therapeutics petosemtamab and zenocutuzumab. He is an expert in antibody engineering and immunology, with more than a dozen granted patents and > 50 peer-reviewed publications. About ATB Therapeutics ATB Therapeutics is an emerging biotechnology company developing atbodies, the next‑generation of weaponized antibody therapies powered by a proprietary portfolio of differentiated payloads with unique modes of action. By integrating these innovative payloads into advanced antibody formats, ATB Therapeutics aims to deliver more precise and potent treatment options for patients across oncology and autoimmune diseases. The company is building a new class of targeted therapeutics designed to overcome limitations of conventional approaches and address significant unmet medical needs. Contacts For Media Inquiries, Contact: ATB Therapeutics Mark Throsby, CEO Email: info@atbtherapeutics.com

100 Deals associated with Petosemtamab

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Indication	Highest Phase	Country/Location	Organization	Date
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	United States	-	25 Sep 2024
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	Japan	-	25 Sep 2024
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	Argentina	-	25 Sep 2024
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	Australia	-	25 Sep 2024
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	Belgium	-	25 Sep 2024
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	Brazil	-	25 Sep 2024
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	Canada	-	25 Sep 2024
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	Chile	-	25 Sep 2024
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	Croatia	-	25 Sep 2024
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	Czechia	-	25 Sep 2024

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT07353957 (MCLA-158-CL04, ASCO2026)	Phase 2	metastatic non-small cell lung cancer First line PD-L1 high	80	Petosemtamab plus pembrolizumab (PD-L1 high (TPS ≥50%) + metastatic non-small cell lung cancer)	nwjfpzwpqs(qcabxgroip) = wuicjbteig blkmbkvxie (vdcnuodeib )	Positive	29 May 2026
Company_Website Manual	Phase 2	MSS/pMMR/MSI-L Colorectal Carcinoma Microsatellite Stable (MSS) \| BRAF Gene Mutation Negative \| KRAS Gene Mutation Negative \| ... View more	54	Petosemtamab + FOLFOX/FOLFIRI (1L treatment)	lokptvtenm(sjjtrvvmbq) = rzvhuivwvr focspeainw (jkmyebhzyn ) View more	Positive	24 Oct 2025
				Petosemtamab + FOLFOX/FOLFIRI (2L treatment)	lokptvtenm(sjjtrvvmbq) = ddcvmznkbl focspeainw (jkmyebhzyn ) View more
NCT03526835 (LiGeR-HN1, ASCO2025)	Phase 2	Esophageal Carcinoma \| Advanced Malignant Solid Neoplasm \| Squamous Cell Carcinoma of Head and Neck ... First line PD-L1+ View more	45	Petosemtamab 1500 mg	sbhomfdllj(riovoousig) = vdewofebib rbdoswnjjl (bajfjtiaua ) View more	Positive	30 May 2025
NCT03526835 (NEWS) Manual	Phase 1/2	Squamous Cell Carcinoma of Head and Neck First line PD-L1 Positive	43	petosemtamab + Keytruda	wpqhxzfazm(vysgjrikzf) = mjxntumdac axmhagrzkk (sdyypvlhtr ) View more	Positive	28 May 2025
				Keytruda (历史数据)	wpqhxzfazm(vysgjrikzf) = wqjiktmudk axmhagrzkk (sdyypvlhtr )
NCT03526835 (ESMO_ASIA2024) Manual	Phase 1/2	Squamous Cell Carcinoma of Head and Neck Second line	54	Petosemtamab 1500 mg (single-arm cohort)	noaqkcwnhm(jxupzqzwfh) = bxmgevnfbe qnuniyrvgc (clrrrawpra ) View more	Positive	07 Dec 2024
				Petosemtamab 1500 mg (dose-comparison cohort)	noaqkcwnhm(jxupzqzwfh) = enmorhslro qnuniyrvgc (clrrrawpra )
Company_Website Manual	Phase 1/2	PD-L1-positive head and neck squamous cell carcinoma Third line PD-L1 Expression	82	Petosemtamab 1500 mg Q2W	odsfhlrkty(sgxswshtih) = bfnazhwswe zspjybhkqm (nllhfslfvb, 27–46) View more	Positive	07 Dec 2024
				Petosemtamab 1100 mg Q2W	odsfhlrkty(sgxswshtih) = jfakfdhwah zspjybhkqm (nllhfslfvb, 8–35) View more
NCT03526835 (GlobeNewswire) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck Second line	54	Petosemtamab 1500 mg	plhugzamkz(sirrlldgez) = klrwzwmvud gzfrwaibcy (rqtdkexuic ) View more	Positive	01 Dec 2024
				Petosemtamab 1100 mg	crgfchcktx(henluqwrpc) = xdasxawzwj vegscxyfjc (zleiqcinoe )
NCT03526835 (phase 2 study, ASCO2024) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck First line	26	Petosemtamab/Pembrolizumab	qflllzuyxo(traevavoec) = mgvhhcopbv awnshdiafe (dbtndtzvle ) View more	Positive	24 May 2024
NCT03526835 (AACR2023) Manual	Phase 1/2	Adenocarcinoma of Esophagus \| stomach adenocarcinoma Third line EGFR Expression	-	Petosemtamab 1500 mg	vhwcfxkttf(uivmkhbfek) = the most frequent AEs regardless of causality (all grades/G3-4) were rash (33%/0%), hypotension (26%/6%), dyspnea (26%/4%), nausea (26%/1%), dermatitis acneiform (24%/1%), blood magnesium decreased (19%/5%), erythema (19%/0%), diarrhea (19%/0%); IRRs (composite term) were reported in 74%/21% of pts, mostly at the first infusion, and all resolved. owioyyhids (zcubhtniky )	Positive	14 Apr 2023
AACR2023 Manual	Not Applicable	Advanced Head and Neck Squamous Cell Carcinoma	49	MCLA-158	tadtcgkiln(bfgiejtwuu) = wrclolndxh zfdeyrqwyr (bersfvyevq ) View more	Positive	14 Apr 2023

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