A PROSPECTIVE LOW-INTERVENTIONAL PHASE 4 SINGLE ARM STUDY OF OCULAR ASSESSMENTS IN PATIENTS TREATED WITH TIVDAK® IN RECURRENT OR METASTATIC CERVICAL CANCER

TIVDAK is used for the treatment of cervical cancer that has come back after chemotherapy. Chemotherapy is a treatment that uses medicines to stop the growth of cancer cells. This is done either by killing the cells or by stopping them from growing. The purpose of this study is to learn about possible side effects of TIVDAK, specially to any side effect that is related to the eye. A side effect is anything a medicine does to your body that is not part of how the medicine treats disease.
* This study is seeking for participants who: Are willing to take all the required eye tests
* Have not received TIVDAK before
* Do not have any active eye issues.
Participants will receive TIVDAK once every 3 weeks as an infusion that will be injected into the vein. Participants will visit an eye care provider at 3 stages:
* before starting the treatment,
* before each of the first 9 infusions
* then monthly for 3 months after they stop taking TIVDAK. Treatment with TIVDAK will continue until it is not working anymore against the participant's cancer.

Start Date07 May 2025

Sponsor / Collaborator

Pfizer Inc.

[+1]

NCT05866354

/ CompletedPhase 1

An Open-Label, Phase 1 Trial to Evaluate Pharmacokinetics of Tisotumab Vedotin in Chinese Subjects With Metastatic or Recurrent Solid Malignancies

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.

NCT04697628

/ CompletedPhase 3

A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin vs Investigator's Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical Cancer

This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent).
Participants in this trial will be randomly assigned to one of two groups. One group will be treated with tisotumab vedotin. Participants in the other group will get one of five different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, pemetrexed, or irinotecan). Participants and their doctors will know which group they are in. Participants in the chemotherapy group will decide with their study doctor which drug they will take.

Start Date22 Feb 2021

Sponsor / Collaborator

Seagen, Inc.

[+1]

100 Clinical Results associated with Tisotumab Vedotin-tftv

100 Translational Medicine associated with Tisotumab Vedotin-tftv

100 Patents (Medical) associated with Tisotumab Vedotin-tftv

536

Literatures (Medical) associated with Tisotumab Vedotin-tftv

01 Apr 2026·Gynecologic Oncology Reports

Tisotumab vedotin–associated Stevens–Johnson syndrome in a patient with recurrent vulvar cancer: Vulnerability and antibody drug conjugate toxicity considerations

Article

Author: Mercier, Ann Marie ; Gross, Sarah ; Chess, Isabel ; Blank, Stephanie V ; Hayes, Monica Prasad

Background:

Severe adverse events from novel cancer therapies are significant concerns, particularly in patients with recurrent disease who have limited treatment options and reduced reserve. We present a rare case of Stevens Johnson Syndrome (SJS) after initiation of tisotumab vedotin (TV) in an elderly patient with recurrent vulvar squamous cell carcinoma (SCC).

Case:

A 76-year-old female with recurrent poorly differentiated vulvar SCC presented with fever, painful rash, and altered mental status 11 days after starting TV. Medical history is notable for HIV (undetectable viral load on antiretroviral medication). Examination revealed a desquamating rash in the bilateral axillae and groin. She was admitted for urosepsis secondary to an obstructing right kidney stone. Two days later, her rash progressed with a positive Nikolsky sign and lesions found in the mouth, axillae, and back. Histopathology frozen section demonstrated SJS and her clinical picture was consistent with toxic epidermal necrolysis (TEN) with a mortality risk of > 90%. The patient and family elected comfort measures. She died on hospital day four.

Conclusion:

A phase III trial on patients with recurrent cervical cancer reported SJS in three patients (representing 1.2% of patients on TV), with one fatal outcome. Given that the median age was 51 and frailer patients were excluded, this trial may underestimate toxicity in a broader population. Multidisciplinary management is essential for frail patients with comorbidities receiving medications such as TV. Further research is necessary to improve outcomes of patients who suffer SJS/TEN and other serious adverse events after TV as its use expands.

01 Apr 2026·INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER

Tisotumab vedotin in Japanese patients with recurrent or metastatic cervical cancer: results from the innovaTV 301/ENGOT-cx12/GOG-3057 trial

Article

Author: Whalley, Elizabeth ; Nakamura, Kazuto ; Mochizuki, Ayako ; Katsumata, Noriyuki ; Yonemori, Kan ; Yunokawa, Mayu ; Yamaguchi, Satoshi ; Okamoto, Aikou ; Usami, Tomoka ; Kamiura, Shoji ; Nishio, Shin ; Fujiwara, Keiichi ; Takehara, Kazuhiro ; Suzuki, Shiro ; Vergote, Ignace ; Noguchi, Hidehisa ; Slomovitz, Brian ; Kobayashi, Hiroaki ; Soumaoro, Ibrahima ; Hasegawa, Kosei

OBJECTIVE:

Tisotumab vedotin resulted in significantly longer overall survival compared with chemotherapy as second- or third-line therapy for recurrent or metastatic cervical cancer in the phase III, multi-national, open-label innovaTV 301/ENGOT-cx12/GOG-3057 trial. We report the results of a sub-group analysis of enrolled Japanese patients.

METHODS:

Patients were randomized 1:1 to tisotumab vedotin or investigator-choice chemotherapy (topotecan [nogitecan hydrochloride], vinorelbine, gemcitabine, irinotecan, or pemetrexed). The primary end point was overall survival.

RESULTS:

Among 502 randomized patients, 101 were Japanese (tisotumab vedotin, n = 50; chemotherapy, n = 51). With 13.7 months of median follow-up in Japanese patients, median overall survival was 15.0 months (95% confidence interval [CI] 9.7 to not estimable) with tisotumab vedotin and 8.5 months (95% CI 6.8 to 10.6) with chemotherapy, representing a 55% lower risk of death with tisotumab vedotin than chemotherapy (hazard ratio 0.45, 95% CI 0.27 to 0.77). Median progression-free survival was 4.0 months (95% CI 3.0 to 4.4) with tisotumab vedotin and 2.0 months (95% CI 1.5 to 3.0) with chemotherapy (hazard ratio 0.63, 95% CI 0.42 to 0.95). The confirmed objective response rate was 24.0% (95% CI 13.1 to 38.2) with tisotumab vedotin and 2.0% (95% CI 0.0 to 10.4) with chemotherapy. All patients in the tisotumab vedotin and chemotherapy arms had ≥1 treatment-emergent adverse event; grade ≥3 events occurred in 42.9% and 66.0%, respectively. Six patients (12.2%) discontinued tisotumab vedotin due to treatment-emergent adverse events.

CONCLUSIONS:

Consistent with global findings, tisotumab vedotin resulted in clinical improvement compared with chemotherapy across all efficacy end points, and demonstrated a manageable adverse event profile in Japanese patients with recurrent or metastatic cervical cancer.

01 Apr 2026·GYNECOLOGIC ONCOLOGY

Tisotumab vedotin plus carboplatin or pembrolizumab in recurrent or metastatic cervical cancer: 5-year results from the innovaTV 205/ENGOT-cx8/GOG-3024 study

Article

Author: Jackson, Amanda L ; Madsen, Kristine ; Windfeld, Kristian ; Denys, Hannelore ; Conte, Umberto ; Sanchez, Luis Manso ; Oaknin, Ana ; Tromp, Jacqueline ; Vergote, Ignace ; Mathews, Cara ; Van Gorp, Toon ; Pisano, Carmela ; Ghamande, Sharad ; Kümmel, Jan ; Ottevanger, Nelleke ; Gennigens, Christine ; Geiger, Melissa ; Randall, Leslie M ; Boere, Ingrid ; Van Nieuwenhuysen, Els ; Monk, Bradley J ; Collins, Dearbhaile C ; Baurain, Jean-Francois ; Reyners, Anna K L ; Hansen, Henrik ; Banerjee, Susana ; Chisamore, Michael ; Zikán, Michal ; O'Cearbhaill, Roisin E ; Cibula, David ; Melichar, Bohuslav ; Salutari, Vanda ; Lorusso, Domenica

OBJECTIVE:

Treatment options for recurrent or metastatic cervical cancer (r/mCC) remain limited. We evaluated the efficacy and safety of tisotumab vedotin (TV)-based combinations with standard agents in first-line (1L) and previously treated (second-line or later [2L+]) settings in r/mCC.

METHODS:

innovaTV 205/ENGOT-cx8/GOG-3024 (NCT03786081) was a multicenter, open-label phase 1b/2 study, which included dose-expansion arms of 1L TV + carboplatin (arm D), 1L/2L+ TV + pembrolizumab (arms E/F), and 1L TV + carboplatin + pembrolizumab ± bevacizumab (arm H). The primary endpoint was investigator-assessed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors v1.1. Secondary endpoints included duration of response (DOR), progression-free survival (PFS), overall survival (OS), and adverse events (AEs).

RESULTS:

As of October 15, 2025, 139 patients were enrolled in dose-expansion arms D (n = 33), E (n = 33), F (n = 35), and H (n = 38). Confirmed ORR (median DOR) was 54.5% (8.6 months), 40.6% (not reached), 35.3% (18.2 months), and 65.8% (13.3 months) in arms D-F and H, respectively. Median PFS was 6.9, 5.3, 5.6, and 10.6 months; median OS was 25.5, 30.7, 15.3, and 28.0 months. Grade ≥ 3 AEs related to any treatment component occurred in 72.7%, 45.5%, 48.6%, and 86.8% of patients; AEs leading to TV discontinuation occurred in 24.2%, 24.2%, 34.3%, and 55.3% of patients in arms D-F and H, respectively.

CONCLUSION:

With ≥ 5 years of follow-up, TV doublet combinations demonstrated durable activity consistent with previous findings and encouraging long-term OS in 1L and 2L+ r/mCC, with no new safety signals. The 1L TV-based triplet/quadruplet regimen showed meaningful antitumor activity with expected toxicity.

159

News (Medical) associated with Tisotumab Vedotin-tftv

09 Jun 2026

·allsci.com

Pfizer/Zai Lab’s Tivdak wins first China market nod for cervical cancer

China’s NMPA issued an approval for Tivdak (tisotumab vedotin) as a treatment for recurrent or metastatic cervical cancer, making it the first antibody-drug conjugate cleared for this indication in China. Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) holds exclusive rights to the drug across Greater China under a license originally executed with Seagen — subsequently acquired by Pfizer — and will be responsible for its commercialization. With an estimated 150,000 new cervical cancer diagnoses annually in China, the approval addresses a population where treatment options after platinum-based chemotherapy remain limited. The NMPA approved Tivdak for adult patients with recurrent or metastatic cervical cancer whose disease has progressed on or after chemotherapy, administered intravenously. Tisotumab vedotin is an ADC comprising a human monoclonal antibody directed against tissue factor (TF), developed by Genmab, conjugated via a protease-cleavable linker to monomethyl auristatin E (MMAE), using Pfizer’s ADC platform technology. Upon binding to TF-expressing tumor cells, the ADC-TF complex is internalized and MMAE is released, disrupting microtubule polymerization and triggering cell cycle arrest and apoptosis. The approval is supported by the global, randomized Phase III innovaTV 301 trial (NCT04697628), which enrolled adults with previously treated recurrent or metastatic cervical cancer. The trial met its primary endpoint of overall survival (OS) in the intention-to-treat population, with a hazard ratio of 0.70 (95% CI: 0.54–0.89; p\=0.0038) versus investigator’s choice chemotherapy. A prespecified China subpopulation analysis, presented at the 2025 Chinese Society of Clinical Oncology meeting, showed an HR of 0.55 (95% CI: 0.27–1.15), corresponding to a reported 45% reduction in the risk of death. Notably, 54.1% of the China subpopulation had received prior anti-PD-(L)1 therapy, and OS benefit trends remained consistent regardless of prior immunotherapy exposure. TF is broadly expressed across multiple solid tumor types, and its role as an ADC target has attracted wider interest. CSPC Pharmaceutical has advanced a TF-targeting ADC into Phase I development for advanced solid tumors, citing Tivdak’s clinical validation of the antigen. The NMPA approval extends a regulatory sequence that includes clearances in the US, EU, Japan, UK, Hong Kong, and Macau, and positions Tivdak as the reference ADC in this indication globally. In the competitive landscape, Tivdak is currently the only approved ADC for recurrent or metastatic cervical cancer and has been designated as the comparator arm in at least one registrational trial for a competing agent: Corbus Pharmaceuticals has aligned with the FDA on a Phase III design for a CSPC-licensed Nectin-4 ADC that uses tisotumab vedotin as the control. Nectin-4-targeting ADCs represent the most active competing modality in this space, with Jiangsu Hengrui’s Nectin-4 ADC having received China breakthrough designation from the same NMPA that approved Tivdak, signaling a likely near-term challenge to its first-mover position in China. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

Phase 3Drug ApprovalImmunotherapyClinical ResultADC

09 Jun 2026

·www.biospace.com

Zai Lab Receives China NMPA Approval of TIVDAK® (tisotumab vedotin for injection) for the Treatment of Adult Patients with Recurrent or Metastatic Cervical Cancer

- TIVDAK is the first antibody-drug conjugate (ADC) approved for the treatment of previously treated recurrent or metastatic cervical cancer in China - TIVDAK demonstrated a statistically significant overall survival benefit in the global Phase 3 innovaTV 301 clinical trial, including in the trial’s China subpopulation SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) has approved the Biologics License Application (BLA) for TIVDAK ® (tisotumab vedotin for injection) for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. This approval is based on results from the global, randomized, Phase 3 innovaTV 301 clinical trial, which met its primary endpoint, demonstrating overall survival (OS) benefit in adult patients with previously treated recurrent or metastatic cervical cancer treated with TIVDAK compared to chemotherapy, including in an exploratory subpopulation of patients in China. The NMPA approval follows regulatory approvals in the United States, Japan, European Union, United Kingdom, Macau (China), and Hong Kong (China), underscoring the broad global clinical evidence supporting TIVDAK availability in China. The indication statement for TIVDAK differs slightly by region. “Cervical cancer remains one of the leading causes of cancer death in women in China. Antibody-drug conjugates have proven to be novel and effective treatments for many types of cancer, and we are pleased to bring this innovative therapeutic class to patients in China with cervical cancer,” said Rafael G. Amado, M.D., President and Head of Global Research and Development at Zai Lab. “Coupled with the previous global approvals of TIVDAK for this disease, the China BLA approval further validates the robust global evidence of clinical benefit for this population of advanced patients with limited therapeutic options.” Results from the Phase 3 innovaTV 301 clinical trial, including data from the China subpopulation of this study that Zai Lab conducted, supported global approval of TIVDAK: In the global study, the trial met its primary endpoint of OS in the intention-to-treat (ITT) population of the global study (HR=0.70; 95% CI: 0.54–0.89; two-sided p=0.0038). The China subpopulation showed consistent results, with a clinically meaningful improvement in OS (HR: 0.55, 95% CI: 0.27- 1.15), corresponding to a 45% reduction in the risk of death compared to chemotherapy. 1 54.1% of the China subpopulation received prior anti-PD(L)1 therapy, the current standard of care for second-line treatment of cervical cancer. TIVDAK showed consistent OS benefit trends irrespective of prior immunotherapy exposure. 2 There were no new safety signals identified among patients in the China subpopulation who received TIVDAK. The most common Grade ≥3 treatment-emergent adverse events (TEAEs) in the global study were anemia (8.4%), urinary tract infection (4.4%), and abdominal pain (4.0%). 1 The most common Grade ≥3 TEAEs in the China subpopulation were anemia (11.4%), cough (5.7%), and malaise (5.7%). 2 “Treatment options are very limited for cervical cancer patients once recurrence or metastasis occurs,” said Dr. Lingying Wu, Ph.D., China Leading Principal Investigator of the innovaTV 301 Study and Professor of the Department of Gynecologic Oncology of National Cancer Center / Cancer Hospital Chinese Academy of Medical Sciences. “Consistent with findings from the global innovaTV 301 trial, the China subpopulation data demonstrate that TIVDAK offers significant clinical benefits to these patients, irrespective of prior PD-(L)1 inhibitor therapy.” Zai Lab will leverage the company’s extensive experience and expanding presence in the Chinese gynecologic oncology community, as well as commercial synergies with its ZEJULA ® team, to bring TIVDAK to patients in China. About Cervical Cancer in China An estimated 150,000 new cases of cervical cancer occur annually in China 3 . Current treatment options are limited for patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy. TIVDAK is well positioned to provide a new option for previously treated advanced cervical cancer patients. About Tisotumab Vedotin Tisotumab vedotin (approved under the brand name TIVDAK ® in the EU, U.K., U.S. and Japan) 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. TIVDAK received full approval from the U.S. Food and Drug Administration in April 2024, and U.S. approval was first secured in September 2021 under the accelerated approval pathway for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Approval has also been received in Japan, European Union, Macau (China), and Hong Kong (China) for the same indication. Zai Lab has an exclusive license from Seagen Inc., a company later acquired by Pfizer, for TIVDAK in Greater China (mainland China, Hong Kong, Macau, and Taiwan, collectively). Zai Lab is solely responsible for the development, supply, and commercialization of TIVDAK in Greater China. About Zai Lab Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health. For additional information about Zai Lab, please visit or follow us at . Zai Lab Forward-Looking Statements This press release contains forward-looking statements relating to our future expectations, plans, and prospects, including, without limitation, statements relating to our prospects and plans for developing and commercializing TIVDAK in Greater China, the potential benefits of TIVDAK, and the potential treatment of cervical cancer. These forward-looking statements may contain words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business decisions, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission. We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Our SEC filings can be found on our website at and the SEC’s website at . References: 1. Vergote I, et al. N Engl J Med. 2024 Jul 4;391(1):44-55. 2. 2025 Chinese Society of Clinical Oncology (CSCO) Meeting, Tisotumab Vedotin versus Chemotherapy in Recurrent or Metastatic Cervical Cancer with Disease Progression on or after Systemic Therapy: Prespecified China Subpopulation Analysis of Phase 3 innovaTV. 3. Bingfeng Han et al., "Cancer incidence and mortality in China, 2022" Journal of the National Cancer Center, 2024. DOI: 10.1016/j.jncc.2024.01.006. Contacts Investor Relations: Christine Chiou +1 (917) 886-6929 christine.chiou1@zailaboratory.com Media: Shaun Maccoun / Xiaoyu Chen +1 (857) 270-8854 / +86 185 0015 5011 shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com

28 May 2026

·pmlive.com

NICE recommends Genmab’s Tivdak for recurrent or metastatic cervical cancer

The National Institute for Health and Care Excellence (NICE) has recommended Genmab UK’s Tivdak (tisotumab vedotin) for adults with recurrent or metas tatic cervical cancer. Tivdak is an antibody-drug conjugate (ADC) that can be used to treat adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy. Cervical cancer is the fourth leading cause of cancer-related deaths globally among women. It is estimated that 3,300 women are diagnosed with cervical cancer each year in the UK, resulting in approximately 900 deaths. The disease recurs in up to 30% of cases among patients who have improved with initial treatment. “Despite real progress in prevention and early detection, women with metastatic or recurrent cervical cancer still face poor outcomes and limited options beyond chemotherapy. While early-stage care has improved, there remains an urgent need for women whose cancer returns or spreads, said Professor Susana Banerjee, UK lead for the phase 3 innovaTV 301 trial, Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, London and Professor in Women’s Cancers at the Institute of Cancer Research. The recommendation is based on results from the global, randomised, phase 3 innovaTV 301 study that evaluated the efficacy and safety of tisotumab vedotin compared to chemotherapy in patients with recurrent or metastatic cervical cancer who were previously treated with chemotherapy doublet as well as bevacizumab and an anti–PD-1 or anti–PD-L1 agent if eligible and available. Lisa Barraclough, consultant clinical oncologist’, said: ‘There remains a significant unmet need for women with cervical cancer whose disease returns or progresses after initial treatment. This marks very important progress for women living with this disease and enables us to offer an alternative treatment in a setting where choices have long been limited.” Matt Kiely, General Manager, UK at Genmab, said: “The positive NICE recommendation for tisotumab vedotin marks an important milestone for eligible women living with recurrent or metastatic cervical cancer. “As the first antibody-drug conjugate licensed in this setting, tisotumab vedotin broadens the options available to clinicians and reflects our commitment to improving outcomes for women affected by gynaecological cancers.” Interim funding via the Cancer Drugs Fund (CDF) will give eligible patients immediate access to the treatment. Subject to final NICE guidance, the treatment is expected to be routinely funded and available for use on the NHS shortly thereafter.

Phase 3Clinical ResultADC

100 Deals associated with Tisotumab Vedotin-tftv

External Link

KEGG	Wiki	ATC	Drug Bank
-	Tisotumab Vedotin-tftv	-	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Advanced Cervical Carcinoma	Japan	Genmab, Inc.	27 Mar 2025
Metastatic Cervical Carcinoma	Macao	Zai Lab Ltd.	06 Aug 2024
Recurrent Cervical Cancer	Macao	Zai Lab Ltd.	06 Aug 2024
Uterine Cervical Cancer	United States	Seagen, Inc.	20 Sep 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Carcinoma to the Uterine Cervix	Phase 3	United States	Seagen, Inc.	22 Feb 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	United States	Genmab A/S	22 Feb 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	China	Seagen, Inc.	22 Feb 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	China	Genmab A/S	22 Feb 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	Japan	Genmab A/S	22 Feb 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	Japan	Seagen, Inc.	22 Feb 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	Argentina	Seagen, Inc.	22 Feb 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	Argentina	Genmab A/S	22 Feb 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	Austria	Seagen, Inc.	22 Feb 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	Austria	Genmab A/S	22 Feb 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03786081 (innovaTV 205, Pubmed \| Gynecol Oncol)	Phase 1/2	Metastatic Carcinoma to the Uterine Cervix First line \| Second line	139	Tisotumab vedotin + carboplatin (1L)	yclxlterrg(kimjdazqms) = mzhwgorfgm zyyhsvwwip (hjolyaapgc ) View more	Positive	01 Apr 2026
				Tisotumab vedotin + pembrolizumab (1L)	yclxlterrg(kimjdazqms) = hpauzaibva zyyhsvwwip (hjolyaapgc ) View more
NCT04697628 (innovaTV 301, ESMO_ASIA2025)	Phase 3	Metastatic Carcinoma to the Uterine Cervix Second line \| Third line	74	Tisotumab vedotin	nqchourtma(mslhtyrdda) = inarpkkjid tlqhfvsedp (gmumwhmsbr, 4.8 - 30.3) View more	Positive	07 Dec 2025
				Investigator’s choice of chemotherapy	nqchourtma(mslhtyrdda) = nichbsxjbn tlqhfvsedp (gmumwhmsbr, 0.6 - 17.3) View more
NCT03786081 (innovaTV 205, ESMO2025)	Phase 2	Metastatic Carcinoma to the Uterine Cervix First line \| Second line \| Third line	101	Tisotumab vedotin plus carboplatin	ptfxjazfyk(sfokmrijzd) = jwgdnddtnk qraufoshsl (ajkueoraiu ) View more	Positive	17 Oct 2025
				Tisotumab vedotin plus pembrolizumab	ptfxjazfyk(sfokmrijzd) = plymolbesp qraufoshsl (ajkueoraiu ) View more
NCT04697628 (innovaTV 301, Company_Website) Manual	Phase 3	Uterine Cervical Cancer	-	TIVDAK	yqxugjbwtq(ezkebwwyio) = flqpkubtpf wnpydesdys (mokhrwnxqq )	Positive	15 Jan 2025
				Chemotherapy	yqxugjbwtq(ezkebwwyio) = kkqnxmsupt wnpydesdys (mokhrwnxqq, 6.0 - NR)
NCT04697628 (innovaTV 301/ENGOT-cx12/GOG 3057 \| SGNTV-003 \| GOG-3057 \| innovaTV 301 \| ENGOT-cx12 \| innovaTV 301/ENGOT-cx12/GOG-3057, CTgov)	Phase 3	Metastatic Carcinoma to the Uterine Cervix	502	tisotumab vedotin (Tisotumab Vedotin)	jydmcgifzh(hzllcxkkgp) = ziwledrimk erohaeluuv (isihcgwwtb, ljolfomvfa - maawmdgxfp) View more	-	09 Aug 2024
				pemetrexed+gemcitabine+Vinorelbine+irinotecan+Topotecan (Chemotherapy)	jydmcgifzh(hzllcxkkgp) = rwihqguzvy erohaeluuv (isihcgwwtb, xbjcphjfxv - zavqdaiwhg) View more
NCT04697628 (innovaTV 301, Pubmed \| N Engl J Med) Manual	Phase 3	Recurrent Cervical Cancer Second line \| Third line	502	Tisotumab vedotin	mnnituxuix(ojstflwidl) = wzigrmrykr kfwfgzlqke (utpsygddsq, 9.8 - 14.9) View more	Positive	04 Jul 2024
				Chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed)	mnnituxuix(ojstflwidl) = cophsoscud kfwfgzlqke (utpsygddsq, 7.9 - 10.7) View more
NCT03485209 (innovaTV 207, ASCO2024) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck	40	Tisotumab vedotin	vkajlpnhga(mpmsoibzkb) = xwyimcojop wvxgxbajwv (dozyviilnz, 18.6 - 49.1) View more	Positive	24 May 2024
				Tisotumab vedotin (≤2 prior lines)	vkajlpnhga(mpmsoibzkb) = aokbakiwrq wvxgxbajwv (dozyviilnz, 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)	hfcyjtzbow(nzlikdjiyl) = inoueibmfx yyleetwtta (xolzhggqal, 13.3 - 23.1) View more	Positive	24 May 2024
				Chemotherapy	hfcyjtzbow(nzlikdjiyl) = vwnmasaoxo yyleetwtta (xolzhggqal, 2.8 - 8.8) View more
NCT04697628 (innovaTV 301 \| ENGOT-Cx12 \| GOG-3057, ESGO2024) Manual	Phase 3	Uterine Cervical Cancer Second line tissue factor	502	Tisotumab vedotin	pgahemdppq(pwtfthusxa) = cxnfpvdrkk iqfgtslpdu (torxaezqix, 9.8 - 14.9) View more	Positive	10 Mar 2024
				investigator’s choice of chemotherapy	pgahemdppq(pwtfthusxa) = kmjwbebrao iqfgtslpdu (torxaezqix, 7.9 - 10.7) View more
NCT03786081 (innovaTV 205/GOG-3024/ENGOT-cx8, Pubmed \| J Clin Oncol)	Phase 1/2	Metastatic Carcinoma to the Uterine Cervix First line \| Third line tissue factor	142	Tisotumab vedotin + Pembrolizumab	yvuhcbrknw(ysnqjfvvfw) = vaarmryufd jzefxjaddj (nhfwqzomdx, 23.7 - 59.4) View more	Positive	20 Dec 2023
				Tisotumab vedotin + Carboplatin	yvuhcbrknw(ysnqjfvvfw) = rheqlgtpfc jzefxjaddj (nhfwqzomdx, 36.4 - 71.9) View more

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