Delving into the Latest Updates on Rinatabart Sesutecan with Synapse

Overview

Basic Info

Drug Type

Antibody drug conjugate (ADC)

Synonyms

Rina-S, GEN1184, PRO 1184

+ [2]

Target

FOLR1 x Top I

Action

antagonists, inhibitors

Mechanism

FOLR1 antagonists(Folate receptor alpha antagonists), TOP1 inhibitors(DNA topoisomerase I inhibitors)

Therapeutic Areas

NeoplasmsEndocrinology and Metabolic DiseaseUrogenital Diseases+ [4]

Active Indication

Platinum-Sensitive Ovarian CarcinomaRecurrent Endometrial CancerFallopian Tube Carcinoma+ [18]

Inactive Indication-

Originator Organization

ProfoundBio (Suzhou) Co., Ltd.

Active Organization

Genmab A/S

ProfoundBio (Suzhou) Co., Ltd.

Inactive Organization-

License Organization

Genmab A/S

ProfoundBio (Suzhou) Co., Ltd.

Drug Highest PhasePhase 3

First Approval Date-

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

Login to view timeline

Structure/Sequence

Boost your research with our ADC technology data.

login

or

view full example data

Boost your research with our ADC technology data.

Sequence Code 1116840435H

Source: *****

Sequence Code 1116840436L

Source: *****

This Phase 3 study will be conducted in different countries around the world with up to about 688 participants.
The purpose of this study is to evaluate how well Rina-S works against ovarian cancer in combination with or without bevacizumab and how it compares to an investigator's choice of platinum-based chemotherapy with or without bevacizumab.
Participants will receive either:
* Rina-S monotherapy (by itself),
* Rina-S plus bevacizumab,
* investigator's choice chemotherapy (by itself) (standard of care), or
* investigator's choice chemotherapy plus bevacizumab (standard of care).
No participants will be given placebo. Participants will participate in 1 of 2 arms.
The treatment duration will be different for every participant. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.
Participants will be asked to attend 1 to 3 visits at the study clinic for each cycle (duration of cycle is 3 or 4 weeks, depending on medication received). During visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity and imaging) to monitor whether the study treatment is safe and effective.
The overall study duration (including screening, treatment, and follow-up) will be different for every participant.

Start Date01 Aug 2026

Sponsor / Collaborator

Genmab A/S

NCT07539311

/ RecruitingPhase 2

A Phase 2, Open-label, Multicohort, Study of Rinatabart Sesutecan (Rina S) in Participants With Advanced Gastrointestinal (GI) Cancers

This Phase 2 study will be conducted in different countries around the world with up to about 160 participants.
The purpose of this study is to evaluate how well Rina-S works against GI cancers.
The medication in this study is Rina-S monotherapy (by itself; no other cancer treatments). All participants will receive active drug; no one will be given placebo.
Participation in the study will require visits to the study site(s). During site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, imaging/X-rays) to monitor whether the study treatment is safe and effective.
The duration of the study will be different for every participant, but an average study duration of 22 months is expected for participants. This will include a treatment period (expected to last an average of 12 months), plus data collection periods before and after treatment. Participants will be asked to attend 1 to 5 visits at the study clinic for each cycle (duration of an individual cycle is 21 days). If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.

Start Date11 May 2026

Sponsor / Collaborator

Genmab A/S

NCT07225270

/ RecruitingPhase 3

A Randomized, Open-Label, Phase 3 Study of Rinatabart Sesutecan (Rina-S) Plus Standard of Care Versus Standard of Care as Maintenance Treatment After 2L Platinum-Based Doublet Chemotherapy in Participants With Recurrent Platinum-Sensitive Ovarian Cancer (PSOC)

This Phase 3 study will be conducted in different countries around the world with up to about 544 participants.
The purpose of this study is to evaluate how well Rina-S works against ovarian cancer in combination with available standard of care therapy that is already approved and used for ovarian cancer.
Participants will receive either Rina-S monotherapy (by itself), Rina-S plus bevacizumab, bevacizumab (standard of care) by itself, or no treatment (only monitoring, also standard of care). No participants will be given placebo. Participants will participate in 1 of 2 arms.
The treatment duration will be different for every participant. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.
Participants will be asked to attend 1 to 3 visits at the study clinic for each cycle (duration of cycle is 3 weeks). During visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity and imaging) to monitor whether the study treatment is safe and effective. The overall study duration (including screening, treatment, and follow-up) for each participant will be different for every participant.

Start Date03 Apr 2026

Sponsor / Collaborator

Genmab A/S

100 Clinical Results associated with Rinatabart Sesutecan

Login to view more data

100 Translational Medicine associated with Rinatabart Sesutecan

Login to view more data

100 Patents (Medical) associated with Rinatabart Sesutecan

Login to view more data

69

News (Medical) associated with Rinatabart Sesutecan

06 Aug 2026

·ir.genmab.com

Genmab Announces Financial Results for the First Half of 2026

August 6, 2026 Copenhagen, Denmark; Interim Report for the Six Months Ended June 30, 2026 Highlights Genmab announced positive Phase 3 results for epcoritamab plus lenalidomide in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), demonstrating statistically significant improvement in progression-free survival Genmab revenue increased 25% compared to the first six months of 2025, to $2,051 million Genmab 2026 financial guidance updated “The second quarter of 2026 delivered clinical progress for our late-stage portfolio. Epcoritamab continued to demonstrate its potential as a core therapy across the spectrum of B-cell malignancies, with strong data across multiple treatment settings and patient populations. At the same time, new data further support the development of Rina-S® (rinatabart sesutecan) in combination in advanced ovarian cancer. Together, these results reflect our continued commitment to delivering meaningful advances for patients,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. Financial Performance First Half of 2026 Revenue was $2,051 million for the first six months of 2026 compared to $1,640 million for the first six months of 2025. The increase of $411 million, or 25%, was primarily driven by higher DARZALEX® and Kesimpta® royalties and higher EPKINLY® net product sales. Royalty revenue was $1,708 million in the first six months of 2026 compared to $1,378 million in the first six months of 2025, an increase of $330 million, or 24%. The increase in royalties was driven by higher net sales of DARZALEX and Kesimpta. Net sales of DARZALEX by J&J were $8,171 million in the first six months of 2026 compared to $6,776 million in the first six months of 2025, an increase of $1,395 million or 21%. Global net sales of EPKINLY/TEPKINLY® were $312 million in the first six months of 2026 compared to $211 million in the first six months of 2025, an increase of $101 million or 48%. Cost of product sales were $149 million for the first six months of 2026 compared to $99 million for the first six months of 2025. The increase of $50 million, or 51%, was primarily driven by the profit-sharing amounts payable to AbbVie related to EPKINLY sales. Adjusted operating expenses, excluding Acquisition and integration related charges, were $1,270 million for the first six months of 2026 compared to $993 million for the first six months of 2025. The increase of $277 million, or 28%, was primarily driven by investment in our product pipeline, including the advancement of Rina-S and petosemtamab, and our global commercialization capabilities in preparation for their anticipated launches. Acquisition and integration related charges related to the integration of Merus were $77 million in the first six months of 2026. Amortization of acquired intangible assets was $24 million for the first six months of 2026 compared to $6 million for the first six months of 2025. The increase of $18 million, was primarily driven by the amortization of the Merus technology platform. Operating profit was $555 million in the first six months of 2026 compared to $548 million in the first six months of 2025. Adjusted operating profit, which excludes Acquisition and integration related charges and Amortization of acquired intangible assets, was $656 million in the first six months of 2026 compared to $554 million in the first six months of 2025. Outlook Genmab is updating its revenue, adjusted operating expenses and adjusted operating profit guidance for 2026. The improved guidance is driven by higher total royalty revenues from DARZALEX and net sales of EPKINLY. 2026 FULL YEAR OUTLOOK 1 Net product sales/Collaboration revenue consists of EPKINLY net product sales in the U.S. and Japan, and Tivdak® ex-U.S. net product sales plus Genmab's share of U.S. gross profits. 2 Adjusted operating expenses and operating profit exclude 2026 charges related to: 1) acquisition and integration-related charges of $90 million and 2) amortization of intangible assets acquired through acquisitions of $47 million. 3 Adjusted operating expenses and operating profit exclude 2026 charges related to: 1) acquisition and integration-related charges of $65 million and 2) amortization of intangible assets acquired through acquisitions of $45 million. Non-IFRS Financial Measures Our Adjusted operating expenses and Adjusted operating profit excludes acquisition and integration related charges and amortization of acquired intangible assets. These charges were recognized in prior periods and will likely reoccur in future periods. These items are excluded from operating expenses and operating profit because the Company believes they neither relate to the ordinary course of the Company's business nor reflect the Company's underlying business performance. Non-IFRS information is intended to portray the results of our baseline performance, supplement or enhance management's, analysts' and investors’ overall understanding of our underlying financial performance and facilitate comparisons among current, past and future periods. This information is not intended to be considered in isolation or as a substitute for the related financial measures prepared in accordance with IFRS and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted. We encourage investors to review our financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure. Conference Call Genmab will hold a conference call to discuss the results for the first six months of 2026 today, Thursday, August 6, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call please use the below registration link. Registered participants will receive an email with a link to access dial-in information as well as a unique personal PIN: https://register-conf.media-server.com/register/BId9cf2ff8aa3c489ca2ad2007d64a1964. A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investor-relations. Contact Marisol Peron, Senior Vice President, Global Communications & Corporate Affairs T: +1 609 524 0065; E: mmp@genmab.com Andrew Carlsen, Vice President, Head of Investor Relations T: +45 3377 9558; E: acn@genmab.com The Interim Report 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 the Interim Report 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®; KYSO®, RAINFOL™, ProfoundBio™ and Rina-S® are trademarks of ProfoundBio, U.S., Co. and Genmab (Suzhou) Co., Ltd. Tivdak® is a trademark of Seagen Inc.; EPCORE®, EPKINLY®, TEPKINLY® and their designs are trademarks of AbbVie Biotechnology Ltd.; Biclonics® and BIZENGRI® are registered trademarks of Merus N.V. Kesimpta® and Sensoready® are trademarks of Novartis AG or its affiliates; DARZALEX®, DARZALEX FASPRO®, RYBREVANT®, RYBREVANT FASPRO™,TECVAYLI® and TALVEY® are trademarks of Johnson & Johnson; TEPEZZA® is a trademark of Horizon Therapeutics Ireland DAC. Download the full Interim Report for the First Half of 2026 on attachment or at www.genmab.com/investor-relations CVR no. 2102 3884 LEI Code 529900MTJPDPE4MHJ122 Genmab A/S Carl Jacobsens Vej 30 2500 Valby Denmark Attachment 060826_CA34_Genmab Interim Report H1 2026

Financial StatementClinical ResultPhase 3

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

100 Deals associated with Rinatabart Sesutecan

Login to view more data

R&D Status

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Platinum-Sensitive Ovarian Carcinoma	Phase 3	United States	Genmab A/S	03 Apr 2026
Platinum-Sensitive Ovarian Carcinoma	Phase 3	Japan	Genmab A/S	03 Apr 2026
Recurrent Endometrial Cancer	Phase 3	United States	Genmab A/S	28 Nov 2025
Recurrent Endometrial Cancer	Phase 3	Japan	Genmab A/S	28 Nov 2025
Recurrent Endometrial Cancer	Phase 3	Australia	Genmab A/S	28 Nov 2025
Recurrent Endometrial Cancer	Phase 3	Belgium	Genmab A/S	28 Nov 2025
Recurrent Endometrial Cancer	Phase 3	Canada	Genmab A/S	28 Nov 2025
Recurrent Endometrial Cancer	Phase 3	Denmark	Genmab A/S	28 Nov 2025
Recurrent Endometrial Cancer	Phase 3	Finland	Genmab A/S	28 Nov 2025
Recurrent Endometrial Cancer	Phase 3	France	Genmab A/S	28 Nov 2025

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT07166094 (RAINFOL-03, ASCO2026)	Phase 3	Endometrial Carcinoma folate receptor alpha (FRα)	544	Rina-S 100 mg/m2	rxpwpcxggg(mrrlitrweq) = jforvkzdeo xbwhtipsar (wjusncgwmy, 22 - 35) View more	Positive	29 May 2026
				Investigator’s choice (IC) therapy (paclitaxel or doxorubicin)	zoplrpmfkt(bqaabwuzfr) = mupaqcgjrh ptlinwsfcg (eoechkszyl ) View more
NCT05579366 (RAINFOL-01, GlobeNewswire \| NEWS) Manual	Phase 1/2	Advanced Endometrial Carcinoma	64	Rina-S 100 mg/m^2Rina-S 100 mg/m^2	yfoolonyag(wkygofhcux) = nancyfwgir opzinuwsih (zuzggihykn, 28.2 - 71.8) View more	Positive	02 Jun 2025
				Rina-SRina-S 120 mg/m^2	yfoolonyag(wkygofhcux) = dgpvcivinc opzinuwsih (zuzggihykn, 29.8 - 64.9) View more
NCT05579366 (GCT1184-01, ASCO2025) Manual	Phase 1/2	Advanced Endometrial Carcinoma	64	Rina-S 100 mg/m2Rina-S 100 mg/m2	qlrwcmztru(cmxbowkjxl) = oqjkpfdcmz qjoqifdyka (gzkqbbqpdz ) View more	Positive	30 May 2025
				Rina-SRina-S 120 mg/m2	qlrwcmztru(cmxbowkjxl) = svvfrixrpd qjoqifdyka (gzkqbbqpdz ) View more
NCT06619236 (phase 3 study, ASCO2025)	Phase 3	Platinum-Resistant Ovarian Carcinoma folate receptor alpha (FRα)	-	Rinatabart sesutecan (Rina-S) 120 mg/m² IV Q3W	sbfwkxerda(osxybdagvd) = cnfklmbynp emuvsneguv (tcsdpxdjvu, 26 - 74)	Positive	30 May 2025
NCT05579366 (RAINFOL-01, PipelineReview) Manual	Phase 1/2	Ovarian Cancer	40	Rina-S 120 mg/m^2	nfygthiftc(jsvrrtfyge) = anmiunkvqk nqifxpuvgk (usmqcagyqa, 30.8 - 78.5) View more	Positive	17 Mar 2025
				Rina-S 100 mg/m^2	nfygthiftc(jsvrrtfyge) = xdpuohhulj nqifxpuvgk (usmqcagyqa, 7.8 - 45.4) View more
NCT05579366 (NEWS) Manual	Phase 1/2	Primary peritoneal carcinoma \| Ovarian Epithelial Carcinoma \| Fallopian Tube Carcinoma	42	Rina-S 100 mg/m2	kajufrhgih(qllwoelwih) = fkccrzkmbv yoptqfugyw (aipuavuvpa ) View more	Positive	23 Sep 2024
				Rina-S 120 mg/m2	kajufrhgih(qllwoelwih) = joaaidohyb yoptqfugyw (aipuavuvpa ) View more
NCT05579366 (PRO1184-001, ESMO2024) Manual	Phase 1/2	Ovarian Cancer \| Endometrial Carcinoma Second line \| Last line \| Third line Folate receptor alpha Positive	101	Rina-S 100 mg/m2	pwprcqjdxr(fphavmzwol) = For Part A pts treated at 100 or 120 mg/m2 (n=35), the most common (≥20%) treatment-related adverse events (TRAEs) were nausea (n=20, 57%), neutropenia (n=18, 51%), leukopenia (n=16, 46%), anemia (n=15, 43%), thrombocytopenia (n=11, 31%), and vomiting (n=9, 26%); most events were Grade 1/2. The most common (≥10%) ≥ Grade 3 TRAEs were neutropenia (n=12, 34%), anemia (n=9, 26%), leukopenia (n=8, 23%), and thrombocytopenia (n=5, 14%). No ocular toxicity or interstitial lung disease was observed. The emerging safety profile of Rina-S in Part B is consistent with Part A. vkwtquiiea (twlpwidpwp )	Positive	15 Sep 2024
				Rina-S 120 mg/m2
NCT05579366 (PRO1184-001, SITC 12023 \| SITC 22023) Manual	Phase 1/2	Locally Advanced Malignant Solid Neoplasm \| Metastatic Solid Tumor Last line FRα expression	36	Rinatabart sesutecan (60 mg/m2-120 mg/m2)	rwplkffcxj(pqrpbhofcb) = Most treatment-related adverse events (TRAEs) are classified as grade 1 or 2. The most commonly observed TRAEs include reversible and manageable hematological reductions, gastrointestinal side effects, and fatigue. yuqikatals (muzzsjvktc )	Positive	02 Nov 2023
				Rinatabart sesutecan (No FRα expression in ovarian cancer and endometrial cancer)

Login to view more data

Translational Medicine

Boost your research with our translational medicine data.

login

or

view full example data

Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.

login

or

view full example data

Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.

login

or

view full example data

Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.

login

or

view full example data

Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.

login

or

view full example data

Accelerate your research with the latest regulatory approval information.

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

login

or

view full example data