The goal of this clinical trial is to test in Chinese Subjects with Metastatic or Recurrent Solid Malignancies. The main questions it aims to answer are:
How is the PK of tisotumab vedotin?
How is the immunogenicity of tisotumab vedotin?
How is the safety and tolerability of tisotumab vedotin?
How is the clinical efficacy of tisotumab vedotin? Participants will receive 2.0 mg/kg tisotumab vedotin (up to a maximum of 200 mg in subjects ≥ 100 kg) as a 30-minute IV infusion 1Q3W with the aim to characterize the PK profiles and to evaluate immunogenicity, safety, and tolerability of tisotumab vedotin in the Chinese population.
Subjects will receive study treatment until disease progression or any other discontinuation criteria are met, whichever occurs first. Subjects will undergo an end of treatment (EOT) visit 30 days (± 5 days) after the last dose of study treatment or within 7 days after treatment discontinuation has been decided, whichever occurs later.

Start Date16 Jun 2023

Sponsor / Collaborator

Zai Lab (Shanghai) Co., Ltd.

CTR20231348 / CompletedPhase 1

一项在复发或转移性的中国实体瘤受试者中评估Tisotumab Vedotin药代动力学的开放性Ⅰ期试验

[Translation] An open-label phase I trial evaluating the pharmacokinetics of tisotumab vedotin in Chinese subjects with recurrent or metastatic solid tumors

主要：评估tisotumab vedotin的PK。次要：评估tisotumab vedotin的免疫原性。评估tisotumab vedotin的安全性和耐受性。探索性：评估tisotumab vedotin的临床疗效。

[Translation]

Primary: To evaluate the PK of tisotumab vedotin. Secondary: To evaluate the immunogenicity of tisotumab vedotin. To evaluate the safety and tolerability of tisotumab vedotin. Exploratory: To evaluate the clinical efficacy of tisotumab vedotin.

Start Date06 Jun 2023

Sponsor / Collaborator

Zai Lab (Shanghai) Co., Ltd.

[+2]

CTR20223290 / RecruitingPhase 3

一项在二线或三线复发性或转移性宫颈癌患者中比较 Tisotumab vedotin 与研究者所选化疗方案的随机、开放标签、III 期试验

[Translation] A randomized, open-label, phase III trial comparing tisotumab vedotin with investigator's choice of chemotherapy in patients with second- or third-line recurrent or metastatic cervical cancer

主要目的：在 2L-3L 宫颈癌参与者中证明 Tisotumab vedotin 相较于化疗的临床疗效改善次要目的：1.在 2L-3L 宫颈癌参与者中评估 Tisotumab vedotin 相较于化疗的临床疗效改善 2.在 2L-3L 宫颈癌参与者中证明 Tisotumab vedotin 相较于化疗的抗肿瘤活性改善 3.在 2L-3L 宫颈癌参与者中表征 Tisotumab vedotin 和化疗的抗肿瘤应答 4.评估 Tisotumab vedotin 的安全性和耐受性 5.评估健康相关生活质量 (HRQOL) 6.评估 Tisotumab vedotin 的药代动力学 (PK) 和免疫原性

[Translation]

Primary objective: To demonstrate improved clinical efficacy of Tisotumab vedotin compared to chemotherapy in participants with 2L-3L cervical cancer Secondary objectives: 1. To evaluate the improved clinical efficacy of Tisotumab vedotin compared to chemotherapy in participants with 2L-3L cervical cancer 2. To demonstrate improved antitumor activity of Tisotumab vedotin compared to chemotherapy in participants with 2L-3L cervical cancer 3. To characterize the antitumor response of Tisotumab vedotin and chemotherapy in participants with 2L-3L cervical cancer 4. To evaluate the safety and tolerability of Tisotumab vedotin 5. To evaluate health-related quality of life (HRQOL) 6. To evaluate the pharmacokinetics (PK) and immunogenicity of Tisotumab vedotin

Start Date09 Feb 2023

Sponsor / Collaborator

Rps Medical Technology (Beijing) Co Ltd

100 Clinical Results associated with Tisotumab Vedotin-tftv

100 Translational Medicine associated with Tisotumab Vedotin-tftv

100 Patents (Medical) associated with Tisotumab Vedotin-tftv

Literatures (Medical) associated with Tisotumab Vedotin-tftv

01 Mar 2024·American journal of ophthalmology case reports

Acute keratoconjunctivitis associated with tisotumab vedotin-tftv for metastatic cervical cancer

Author: Hanna, Jovana ; Parikh, Ankur A ; Shah, Amar P

Purpose:

Tisotumab vedotin-tftv, an antibody-drug conjugate, was recently FDA-approved for metastatic or treatment-resistant cervical cancer. A high rate of ocular comorbidities was seen in pivotal clinical trials. We present a case of a 46-year-old woman who experienced prolonged ocular surface adverse effects associated with use of the drug.

Observations:

Our patient was initiated on tri-weekly 2mg/kg infusions of tisotumab for metastatic cervical cancer. Baseline ophthalmic exam was unremarkable. One week after the second infusion, she developed bilateral eyelid edema and chalazia managed with initiation of lid hygiene measures. Preceding the fourth infusion, she developed unilateral pseudomembranous conjunctivitis and bilateral meibomitis that improved with topical corticosteroids. The fifth infusion was subsequently given at a reduced dosage. Despite this, she experienced decreased vision, bilateral diffuse punctate epitheliopathy, and subepithelial haze. The patient was subsequently referred to the cornea service. Symptomatic and clinical improvement was initially achieved with the addition of bandage contact lenses (BCLs). As the keratitis improved, topical steroids were tapered and BCLs removed. She is currently maintained on a regimen that includes eyelid hygiene, preservative-free artificial tears, punctal plugs, autologous serum tears, and lifitegrast. Given the severity of the ophthalmic adverse effects, however, further tisotumab infusions were held.

Conclusions and importance:

This is a report of a patient with prolonged ocular surface disease following the initiation of tisotumab, significant enough to lead to discontinuation. Antibody-drug conjugates are an emerging class of therapeutics across oncology, and ophthalmologists should be aware of their potential effects on ocular health.

01 Feb 2024·Current opinion in obstetrics & gynecology

A review of the state of cervical cancer: updates from prevention to recurrent disease

Review

Author: Salani, Ritu ; Venkat, Puja S ; Crafton, Sarah M

Purpose of review:

To summarize the recent updates in cervical cancer from prevention and early detection to the management of early stage and recurrent disease as well as future areas of exploration.

Recent findings:

The importance of the human papilloma virus vaccine and screening continue to make an impact in reducing the global burden of cervical cancer. In early-stage, low risk disease, new studies have demonstrated the role of less radical surgery with similar disease related outcomes. Efforts to improve outcomes in locally advanced cervical cancer have been reported. The incorporation of adjuvant chemotherapy, novel agents and checkpoint inhibitors, with the latter impacting disease free survival. In advanced/recurrent disease, the role of immunotherapy continues to make an impact and, in addition to recurrent disease, has now moved to the frontline for patients with programmed cell death ligand 1 expression. Tisotumab vedotin, an antibody drug conjugate, and other novel agents continue to be studied in this setting.

Summary:

In this review, we discuss prevention measures and the outcomes of recent trials in all stages of cervical cancer. As therapies continue to evolve, ongoing trials and new areas of exploration will continue to identify opportunities to improve survival in cervical cancer.

01 Jan 2024·Current treatment options in oncology

Antibody-Drug Conjugates in Gynecologic Cancers

Review

Author: Davidson, Brittany A ; Shuey, Stephanie ; Anastasio, Mary Katherine

OPINION STATEMENT:

Antibody-drug conjugates (ADCs) are a novel class of targeted cancer therapies with the ability to selectively deliver a cytotoxic drug to a tumor cell using a monoclonal antibody linked to a cytotoxic payload. The technology of ADCs allows for tumor-specificity, improved efficacy, and decreased toxicity compared to standard chemotherapy. Common toxicities associated with ADC use include ocular, pulmonary, hematologic, and neurologic toxicities. Several ADCs have been approved by the United States Food and Drug Administration (FDA) for the management of patients with recurrent or metastatic gynecologic cancers, a population with poor outcomes and limited effective treatment options. The first FDA-approved ADC for recurrent or metastatic cervical cancer was tisotumab vedotin, a tissue factor-targeting agent, after demonstrating response in the innovaTV 204 trial. Mirvetuximab soravtansine targets folate receptor alpha and is approved for use in patients with folate receptor alpha-positive, platinum-resistant, epithelial ovarian cancer based on results from the SORAYA trial. While there are no FDA-approved ADCs for the treatment of uterine cancer, trastuzumab deruxtecan, an anti-human epidermal growth factor receptor 2 (HER2) agent, is actively being investigated. In this review, we will describe the structure and mechanism of action of ADCs, discuss their toxicity profiles, review ADCs both approved and under investigation for the management of gynecologic cancers, and discuss mechanisms of ADC resistance.

News (Medical) associated with Tisotumab Vedotin-tftv

03 Jun 2024

·www.globenewswire.com

Investigational Tisotumab Vedotin Phase 2 Data Demonstrates Encouraging Antitumor Activity in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Media Release COPENHAGEN, Denmark; June 3, 2024 Results from innovaTV207 evaluating tisotumab vedotin, showing 32.5% confirmed objective response rate in patients with recurrent or metastatic HNSCC, presented in a rapid oral session at 2024 ASCO® Annual MeetingHNSCC is the sixth most common cancer worldwide, with incidence rates expected to increase 30% by 2030i Genmab A/S (Nasdaq: GMAB) announced today that data from the Phase 2 innovaTV 207 trial (NCT03485209) Part C (n=40), investigating tisotumab vedotin, an antibody-drug conjugate directed to tissue factor, demonstrated encouraging antitumor activity as a monotherapy in patients with head and neck squamous cell carcinoma (HNSCC) who experienced disease progression on or after first-line therapy. The study showed 32.5% of patients achieved a confirmed objective response rate (cORR), one patient experienced a complete response (CR) and 12 achieved a partial response (PR). These results were presented in a rapid oral session today at the 2024 ASCO Annual Meeting, being held in Chicago, Illinois, May 31 – June 4, 2024. In the HNSCC cohort of innovaTV 207 Part C (n=40), median duration of response (DOR) was 5.6 months and median time-to-response (TTR) was 1.4 months. All patients were required to have received a platinum-based regimen in the recurrent or metastatic setting or have persistent disease following platinum-based chemoradiation and a checkpoint inhibitor (CPI), if eligible. The study also showed that among patients with no more than one or two lines of therapy in the recurrent or metastatic setting (n=25), 40% had achieved a cORR at the time of data cut-off. “Most patients with recurrent or metastatic head and neck squamous cell carcinoma experience disease progression despite the use of platinum-based therapy and immunotherapy, and treatment options are limited,” said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab, “These updated results underscore the importance of our ongoing work with our partner to advance the clinical development program for tisotumab vedotin and investigate potential treatment options for pretreated patients living with unmet needs.” The safety findings were consistent with previous tisotumab vedotin trials, and no new safety signals were observed. Grade ≥3 treatment-emergent adverse events (TEAEs) occurred in 67.5% of patients, and the most common were peripheral neuropathy events (40%). Adverse events of special interest (of any grade) were prespecified for ocular, peripheral neuropathy, and bleeding events, and occurred in 52.5%, 47.5%, and 40% patients, respectively. As of December 2023, 40 patients with recurrent or metastatic HNSCC were treated with tisotumab vedotin monotherapy (1.7 mg/kg intravenously, once every two weeks). In this cohort, 32 (80%) received prior platinum-based therapy, 19 (47.5%) received at least two prior lines of systemic therapy (median: 2; range: 1-3), 40 (100%) received prior CPI, 23 (57.5%) received prior taxane, and 27 (67.5%) received prior cetuximab. The primary sites at diagnosis were oropharynx (n=16), larynx (n=13), and oral cavity (n=9). About the innovaTV 207 TrialThe innovaTV 207 trial (NCT03485209) is an open-label, global, Phase 2, multicohort, multicenter study evaluating tisotumab vedotin monotherapy or in combination for advanced solid tumors. In Part C, patients with recurrent or metastatic HNSCC received tisotumab vedotin monotherapy (1.7 mg/kg IV once every two weeks). All patients were required to have received a platinum-based regimen, either in the recurrent/metastatic setting, or to have persistent disease following platinum-based chemoradiation and a checkpoint inhibitor, if eligible. The primary endpoint of the trial is confirmed objective response rate (cORR) per RECIST 1.1 per investigator, defined as the proportion of patients who achieve a confirmed complete or partial response. Selected secondary endpoints include duration of response (DOR), time-to-response (TTR), and safety. For more information about the phase 2 innovaTV 207 clinical trial of tisotumab vedotin, please visit www.clinicaltrials.gov. About Tisotumab VedotinTisotumab vedotin is an antibody-drug conjugate (ADC) composed of Genmab’s human monoclonal antibody directed to tissue factor (TF) and Pfizer’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. Nonclinical data suggest that the anticancer activity of tisotumab vedotin-tftv is due to the binding of the ADC to TF-expressing cancer cells, followed by internalization of the ADC-TF complex, and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro, tisotumab vedotin-tftv also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity. Tisotumab vedotin (TIVDAK®) has received full approval by the U.S. FDA for the treatment of adult patients with recurrent or metastatic cervical cancer (r/mCC) with disease progression on or after chemotherapy. Tisotumab vedotin in HNSCC is not approved in any country, including the U.S. and the EU. The safety and efficacy of tisotumab vedotin has not been established for these investigational uses. Virtual mid- to late-stage pipeline update at ASCO 2024On Monday, June 3, at 9:00 AM CDT (10:00 AM EDT/4:00 PM CEST), Genmab will host a review of data presented at ASCO from its mid- to late-stage pipeline. The event will be virtual and webcast live. Details, including the webcast link and registration will be available on www.genmab.com. This meeting is not an official program of the ASCO Annual Meeting. About GenmabGenmab 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 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. About the Pfizer and Genmab Collaboration Tisotumab vedotin is co-owned by Genmab and Pfizer, under an agreement in which the companies share costs and profits for the product on a 50:50 basis. Contact: David Freundel, Senior Director, Global Communications & Corporate AffairsT: +1 609 430 2481; E: dafr@genmab.com Andrew Carlsen, Vice President, Head of Investor RelationsT: +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 pre-clinical 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™. Tivdak® is a trademark of Pfizer Inc. i Johnson, Daniel E., et al. “Head and Neck Squamous Cell Carcinoma.” Nature Reviews Disease Primers, Nature Publishing Group, 26 Nov. 2020, https://www-nature-com.libproxy1.nus.edu.sg/articles/s41572-020-00224-3#Fig2. Media Release no. 10CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122 Genmab A/SCarl Jacobsens Vej 302500 ValbyDenmark Attachment 030624_MRi10_TV207 ASCO HNSCC GLOBAL

Clinical ResultPhase 2ImmunotherapyADCDrug Approval

31 May 2024

·www.biospace.com

ASCO24 Preview: A Look at Some of the Cancer Meeting’s Hottest Abstracts

Pictured: Chicago landscape oncology collage/Nicole Bean for BioSpace The American Society of Clinical Oncology annual meeting kicks off today in Chicago, with several companies releasing highly anticipated abstracts ahead of time. Here are some that caught our attention: Targeted Oncology Making headlines, Merus experienced a run on its stock with shares rising one-third last Friday after it announced data from a Phase II study indicating that its bispecific antibody petosemtamab in combination with immunotherapy Keytruda produced a 67% response rate in head and neck cancer. The results will be presented at ASCO as a rapid oral abstract session on June 3 at 8 a.m. in room E450b. “Petosemtamab in combination with pembrolizumab (Keytruda) has demonstrated clinically meaningful activity in first line head and neck cancer, with a 67% response rate overall, observed across tumor PD-L1 expression levels and HPV status and with encouraging safety," said Bill Lundberg, the president and CEO of Merus, in a press release ahead of the presentation. Analysts from William Blair reported confidence in the results, writing in a report: “This unprecedented level of activity in metastatic head and neck cancer patients sets petosemtamab as the most effective combination partner for Keytruda in head and neck cancer patients.” Merus plans to initiate a Phase III study later this year. CAR-T Following CAR-T therapy Carvykti’s recent expansion into second line treatment for multiple myeloma, Legend Biotech and Johnson & Johnson are scheduled to present clinical data from the Phase II multicohort CARTITUDE-2 study evaluating the treatment’s safety and efficacy in various multiple myeloma treatment settings and patient populations (abstract #7535, #7505). Carvykti is the first and only B-cell maturation antigen (BCMA)-targeted therapy approved to treat patients with multiple myeloma as early as the first relapse. It was approved by the FDA on April 5 for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide. “While we expect the updates to be incremental to Legend’s stock, we believe they will further support the use of BCMA CAR-T cell therapies in the early-line setting,” William Blair analyst Sami Corwin wrote in a report. Emerging Oncology and Immunotherapies On June 3, researchers will be presenting Phase II data on Pfizer and Genmab’s Tivdak (tisotumab vedotin) in head and neck squamous cell carcinoma. Analysts from Leerink Partners were encouraged by the data, positing that they “could see antibody drug-conjugates (ADCs) eventually replace chemotherapy in [the] head and neck cancer treatment paradigm, particularly in the second line space,” according to a report. Additionally, analysts “would be keen to see detail on the tolerability, particularly the avoidance of bleeding events, which had been a concern in previous studies evaluating tisotumab vedotin in head and neck cancer,” according to the report. “[Immunotherapies] have the potential to change the lives of patients by changing progressive cancer into a stable disease associated with improved overall survival,” said Paul Peter Tak, president & CEO of Candel Therapeutics, which will present data on its immunotherapy candidate CAN-2409 (ASCO abstract #8634). Tak told BioSpace the data show that in non-small cell lung cancer patients with progressive disease despite immune checkpoint inhibitor therapy, two administrations of CAN-2409 + valacyclovir resulted in a median overall survival of 20.6 months. This compares to the median overall survival of 11.6 months observed with the standard of care docetaxel-based chemotherapy in a similar patient population. Another abstract highlighted by Leerink Partners is Nanobiotix’s Study 1100 (ASCO abstract #6035). The company is evaluating NBTXR3, which is a radioenhancer composed of functionalized hafnium oxide crystalline nanoparticles, and stereotactic body radiation therapy followed by PD-1 inhibitors nivolumab or pembrolizumab in patients with advanced solid tumors. Leerlink noted the “concept of reconstituting some sensitivity to anti-PD-1 therapy in patients who have progressed” is especially of note, considering that most attempts to do so have so far failed. The report adds that analysts are interested in seeing how the company moves forward by teasing out signals from its “hypothesis-generating dataset.” Mollie Barnes is a freelance science writer. Reach her at mollie@100yearsco.com. Follow her on Threads and Instagram @shejustlikedtogo or LinkedIn. See more of her work at molliebarnes.contently.com.

ImmunotherapyClinical ResultPhase 2ASCODrug Approval

23 May 2024

·www.globenewswire.com

Genmab to Showcase Data in Various Patient Populations to be Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting

Media ReleaseCOPENHAGEN, Denmark; May 23, 2024 Six oral and poster presentations will highlight breadth of clinical program and potential utility of epcoritamab-bysp in patients with difficult-to-treat lymphomas across multiple lines of therapy and histologies where high unmet needs existResults from two studies evaluating tisotumab vedotin in patients with head and neck squamous cell carcinoma and recurrent or metastatic cervical cancer accepted for oral and poster presentations, respectivelyFirst presentation of Phase 2 study of acasunlimab (also known as GEN1046/BNT311) in patients with previously treated metastatic non-small cell lung cancer (mNSCLC) Genmab A/S (Nasdaq: GMAB) announced today that multiple abstracts evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, tisotumab vedotin, an antibody-drug conjugate (ADC), and acasunlimab (also known as GEN1046/BNT311), an investigational bispecific antibody, will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, IL and virtually, May 31-June 2, 2024. “The data being presented this year at ASCO demonstrate Genmab’s significant progress towards our mission to develop novel antibody therapies with the goal of improving the lives of people impacted by cancer,” said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. Presentations will include data from multiple clinical trials evaluating the efficacy and safety of epcoritamab in a variety of treatment settings and patient populations, including a rapid oral presentation evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with previously untreated follicular lymphoma (FL) and a second rapid oral presentation showcasing results from the pivotal and cycle 1 dose optimization cohorts of EPCORE NHL-1 evaluating epcoritamab in patients with relapsed/refractory (R/R) FL. Data from the Phase 2 innovaTV 207 trial, evaluating tisotumab vedotin in pretreated patients with relapsed/metastatic head and neck squamous cell carcinoma will be presented during a rapid oral session. Additionally, results from the Phase 3 innovaTV 301 trial evaluating tisotumab vedotin in patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy will be presented. Finally, data from the Phase 2 clinical trial evaluating acasunlimab as monotherapy and in combination with pembrolizumab in patients with previously treated metastatic non-small cell lung cancer (mNSCLC) will be presented for the first time during a poster presentation. The safety and efficacy of these investigational medicines have not been established for these uses. Virtual mid- to late-stage pipeline update at ASCO 2024On Monday, June 3, at 9:00 AM CDT (10:00 AM EDT/4:00 PM CEST), Genmab will host a review of data presented at ASCO from its mid- to late-stage pipeline. The event will be virtual and webcast live. Details, including the webcast link and registration will be available on www.genmab.com. This meeting is not an official program of the ASCO Annual Meeting. All abstracts accepted for presentation have been published and may be accessed online via the ASCO Meeting Library. Abstracts accepted for presentation at ASCO: Epcoritamab: Abstract NumberAbstract TitleType of PresentationDate/Time of Presentation7014Epcoritamab with rituximab + lenalidomide (R2) in previously untreated (1L) follicular lymphoma (FL) and epcoritamab maintenance in FL: EPCORE NHL 2 arms 6 and 7Rapid OralJune 2, 4:30-6:00 PM CDT7015EPCORE NHL 1 follicular lymphoma (FL) cycle (C) 1 optimization (OPT) cohort: Expanding the clinical utility of epcoritamab in relapsed or refractory (R/R) FLRapid OralJune 2, 4:30-6:00 PM CDT7029Subcutaneous Epcoritamab (SC epcor) administered outpatient (outpt) for relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL): Results from Phase 2 EPCORE NHL-6PosterJune 3, 9:00 AM-12:00 PM CDT7032Epcoritamab + R-DHAX/C in transplant-eligible patients (pts) with high-risk relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL)PosterJune 3, 9:00 AM-12:00 PM CDT7037Subcutaneous epcoritamab + GemOx in patients with relapsed or refractory DLBCL: Updated results from EPCORE NHL-2PosterJune 3, 9:00 AM-12:00 PM CDT7039Extended follow-up results beyond 2.5 years from the pivotal NHL-1 EPCORE trial: Subcutaneous epcoritamab monotherapy in patients with relapsed/refractory large B-cell lymphoma (R/R LBCL)PosterJune 3, 9:00 AM-12:00 PM CDTTPS7084EPCORE FL-2: Phase 3 trial of epcoritamab with rituximab and lenalidomide (R2) vs chemoimmunotherapy or R2 in previously untreated follicular lymphomaPosterJune 3, 9:00 AM-12:00 PM CDT Tisotumab Vedotin: Abstract NumberAbstract TitleType of PresentationDate/Time of Presentation6012Tisotumab vedotin in head and neck squamous cell carcinoma: updated analysis from innovaTV 207 Part CRapid OralJune 3, 8:00-9:30 AM CDT5531Tisotumab vedotin in 2L/3L recurrent or metastatic cervical cancer: subsequent therapy data from ENGOT-cx12/GOG-3057/innovaTV 301PosterJune 3, 9:00 AM-12:00 PM CDT Acasunlimab: Abstract NumberAbstract TitleType of PresentationDate/Time of Presentation2533Acasunlimab (DuoBody-PD-L1x4-1BB) alone or in combination with pembrolizumab (pembro) in patients (pts) with previously treated metastatic non-small cell lung cancer (mNSCLC): initial results of a randomized, open-label, Phase 2 trialPosterJune 1, 9:00 AM-12:00 PM CDT About Epcoritamab Epcoritamab-bysp 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 towards 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 is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. Epcoritamab has received regulatory approval in certain lymphoma indications in several territories. Use of epcoritamab in FL is not approved in the U.S. or in the EU or in any other territory. 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. 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 four 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 (NCT: 04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult participants with newly diagnosed DLBCL (NCT: 05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide in patients with R/R FL (NCT: 05409066), and a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemotherapy in patients with previously untreated FL (NCT: 06191744). The safety and efficacy of epcoritamab has not been established for these investigational uses. About Tisotumab VedotinTisotumab vedotin is an antibody-drug conjugate (ADC) composed of Genmab’s human monoclonal antibody directed to tissue factor (TF) and Pfizer’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. Nonclinical data suggest that the anticancer activity of tisotumab vedotin is due to the binding of the ADC to TF-expressing cancer cells, followed by internalization of the ADC-TF complex, and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro, tisotumab vedotin also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity. Tisotumab vedotin is co-owned by Genmab and Pfizer, under an agreement in which the companies share costs and profits for the product on a 50:50 basis. Tisotumab vedotin has received full approval by the U.S. FDA for the treatment of adult patients with recurrent or metastatic cervical cancer (r/mCC) with disease progression on or after chemotherapy. Tisotumab vedotin in HNSCC is not approved in any country, including the U.S. and the EU. About Acasunlimab (GEN1046/BNT311)Acasunlimab (GEN1046/BNT311) is an investigational PD-L1x4-1BB bispecific antibody fusing Genmab's proprietary DuoBody® technology platform and BioNTech’s proprietary immunomodulatory antibodies. Acasunlimab is designed to elicit an antitumor response via conditional activation of 4-1BB on T cells and natural killer (NK) cells, which is strictly dependent on simultaneous binding of the PD-L1 arm.Acasunlimab is being developed in collaboration with BioNTech SE under a license and collaboration agreement and is currently in Phase 2 of development. Please visit www.clinicaltrials.gov for more information about Genmab’s clinical trials. 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 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: +1 609 430 2481; 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 pre-clinical 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®; DuoBody in combination with the DuoBody logo®; HexaBody®; HexaBody in combination with the HexaBody logo®; DuoHexaBody® and HexElect®. EPKINLY® and EPCORE® are owned by AbbVie Biotechnology Ltd. i Engelberts 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. 07CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122 Genmab A/SCarl Jacobsens Vej 302500 ValbyDenmark Attachment 230524_MRi07_Genmab ASCO 2024 Curtain Raiser Media Release

Phase 2Phase 3Clinical ResultASCOLicense out/in

100 Deals associated with Tisotumab Vedotin-tftv

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Uterine Cervical Cancer	US	Seagen Inc.	20 Sep 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Cervical Carcinoma	NDA/BLA	US	Pfizer Inc.	09 Jan 2024
Metastatic Cervical Carcinoma	NDA/BLA	US	Genmab A/S	09 Jan 2024
Recurrent Cervical Cancer	NDA/BLA	US	Pfizer Inc.	09 Jan 2024
Recurrent Cervical Cancer	NDA/BLA	US	Genmab A/S	09 Jan 2024
Metastatic Carcinoma to the Uterine Cervix	Phase 3	US	Seagen Inc.	22 Feb 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	CN	Seagen Inc.	22 Feb 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	JP	Seagen Inc.	22 Feb 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	AR	Seagen Inc.	22 Feb 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	AT	Seagen Inc.	22 Feb 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	BE	Seagen Inc.	22 Feb 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03485209 (innovaTV 207, ASCO2024) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck	40	Tisotumab vedotin	ncemiapgvj(eixgaxfufb) = wtikwmdukn nkpkulbwvk (zftufdhawt, 18.6-49.1) View more	Positive	24 May 2024
				Tisotumab vedotin (≤2 prior lines)	ncemiapgvj(eixgaxfufb) = ghfqlhsnwy nkpkulbwvk (zftufdhawt, 21.1-61.3) View more
NCT04697628 (ENGOT-cx12 \| GOG-3057 \| innovaTV 301, ASCO2024) Manual	Phase 3	Uterine Cervical Cancer Second line \| Third line	502	Tisotumab vedotin (TV)	vzkrqenftx(tqlvdkvvkr) = irabmyvbjz rlablfdsic (pwkarsmuwi, 13.3-23.1) View more	Positive	24 May 2024
				Chemotherapy	vzkrqenftx(tqlvdkvvkr) = aoepzanfrz rlablfdsic (pwkarsmuwi, 2.8-8.8) View more
NCT04697628 (innovaTV 301/ENGOT-Cx12/GOG-3057, ESGO2024)	Phase 3	Metastatic Carcinoma to the Uterine Cervix tissue factor	502	Tisotumab vedotin monotherapy	clvqjdqfsq(bofjwwkzho) = irrsfrdnvm dpmhuhohay (uussrkkdrz ) View more	Positive	10 Mar 2024
				Investigator's choice of topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed	clvqjdqfsq(bofjwwkzho) = lercemvnyi dpmhuhohay (uussrkkdrz ) View more
NCT04697628 (innovaTV 301 \| SGNTV-003 \| GOG-3057 \| ENGOT-cx12, ESMO2023) Manual	Phase 3	Uterine Cervical Cancer Third line \| Second line	502	Tisotumab vedotin	nwkepbgmds(wkodvhvqsp) = btnmbvrcsy lhffsrgiwv (jxgosmkkmo, 9.8-14.9) View more	Positive	22 Oct 2023
				Investigator's choice of chemotherapy	nwkepbgmds(wkodvhvqsp) = wcrwraqgfp lhffsrgiwv (jxgosmkkmo, 7.9-10.7) View more
NCT04697628 (innovaTV 301, NEWS) Manual	Phase 3	Uterine Cervical Cancer First line	-	Tivdak	eimycgmwiw(xytufnbvfi) = 在一线治疗期间或治疗后疾病发生进展的复发性或转移性宫颈癌患者中，与单独化疗相比，接受其“first-in-class”抗体偶联药物（ADC）Tivdak（tisotumab vedotin）患者的OS显著改善 vzewjwidab (izweunatle ) Met View more	Positive	06 Sep 2023
				chemotherapy
NCT03657043 (CTgov)	Phase 2	Peritoneal Neoplasms \| Platinum-Resistant Ovarian Carcinoma \| Fallopian Tube Carcinoma	98	3Q4W (Safety Run-In 0.9 mg/kg 3Q4W)	axcdrvzwcp(yezmarqdsb) = crplamszhb zttqsnisyo (perovutetz, hadrlcxojt - anyzlhdreg) View more	-	06 May 2023
				3Q4W (Safety Run-In 1.2 mg/kg 3Q4W)	axcdrvzwcp(yezmarqdsb) = jcmpjsrwzq zttqsnisyo (perovutetz, djbivioyoy - zxjjfifzew) View more
NCT03485209 (innovaTV 207, AACR2023) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck	15	Tisotumab vedotin	hygrgoqprc(nwzimursqm) = oxcgrgtsty sodcaireeg (cxscyvuerr, 16.3 - 67.7) View more	Positive	14 Apr 2023
ESMO_GCC2023	Not Applicable	Metastatic Carcinoma to the Uterine Cervix	-	Tisotumab vedotin	jmxngimznh(fyolahahae) = amephdswmt uyqsmnoblf (aflkpcxlpy ) View more	-	23 Feb 2023
innovaTV 204/GOG-3023/ENGOT-cx6 (IGCS2022)	Not Applicable	tissue factor (TF)	-	Tisotumab vedotin	zwfaxbvqun(prawglrjjb) = 54% of patients exhibited OAEs (1.4-month median onset, IQR 0.7–2.0), mostly Grade 1–2 in severity. Common events included conjunctivitis, dry eye, and keratitis. Four patients experienced visual acuity changes; 3 resolved at last follow-up. dzjfrookyk (qxtsborctk )	-	04 Dec 2022
ENGOT Cx8/GOG-3024/innovaTV205 (ESGO2022)	Not Applicable	Recurrent Cervical Cancer Second line	-	TV + pembrolizumab	xxrgjelwyc(gblamewrgx) = lrblgozilp wrtgwzncjz (zkqihgyfsz ) View more	-	20 Oct 2022
				TV + carboplatin	xxrgjelwyc(gblamewrgx) = levnpvmqbq wrtgwzncjz (zkqihgyfsz ) View more

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