Tivdak (tisotumab vedotin-tftv) / Genmab, ZAI Lab, Pfizer - LARVOL DELTA

Cost-effectiveness of second- or third-line treatment with tisotumab vedotin for metastatic or recurrent cervical cancer. (PubMed, Expert Rev Pharmacoecon Outcomes Res) - "To evaluate the cost-effectiveness of tisotumab vedotin (TV) versus single-agent chemotherapy in patients with recurrent or metastatic cervical cancer (r/mCC) after failure of first-line treatment, from the perspective of the Spanish National Health System. TV offers a modest benefit over chemotherapy in patients with r/mCC and reaches or surpasses the upper bounds of ICER applied in Spain when priced comparably to cemiplimab. However, the magnitude of clinical benefit is uncertain."

HEOR • Journal • Cervical Cancer • Oncology • Solid Tumor

Tisotumab vedotin vs investigator's choice of chemotherapy as second- or third-line (2L/3L) treatment for Chinese patients (pts) with recurrent or metastatic cervical cancer (r/mCC) in innovaTV 301 (ESMO Asia 2025) - P3 | "This report presents the first analysis of efficacy and safety of TV in Chinese pts with r/mCC, based on data from both global and China extension portions within innovaTV 301. Eligible pts had r/mCC with disease progression following standard chemotherapy doublet ± bevacizumab ± anti-PD-(L)1 therapy, measurable disease per RECIST v1.1, and an ECOG performance status of 0-1. Pts were randomised 1:1 to receive TV monotherapy or investigator's choice of topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed... TV as 2L/3L treatment demonstrated clinically meaningful improvements in OS, PFS, and ORR vs chemotherapy, with a manageable safety profile, for Chinese pts with r/mCC."

Clinical • Metastases • Cervical Cancer • Oncology • Solid Tumor

Efficacy and safety of HLX43 (an anti-PD-L1 ADC) in recurrent/metastatic cervical cancer (CC): A randomised, multicentre, phase II study (ESMO Asia 2025) - P2 | "Background: Tisotumab vedotin (a tissue factor-targeting ADC) has demonstrated efficacy in recurrent/advanced cervical cancer (CC) and was approved for this indication. HLX43, particularly at 3 mg/kg, exhibited promising efficacy and manageable safety in patients with previously treated recurrent/metastatic CC. Further investigation of HLX43 is warranted."

Clinical • IO biomarker • Metastases • P2 data • Cervical Cancer • Oncology • Solid Tumor • PD-L1

Novel Treatment Concepts for Cervical Cancer-Moving Towards Personalized Therapy. (PubMed, J Pers Med) - "Particularly, the combination of platinum-based chemotherapy and pembrolizumab, with or without bevacizumab, has been established as the new standard treatment for primary metastatic or recurrent PD-L1 positive high-risk cervical cancer. In locally advanced cervical cancer, two new treatment escalation regimens-neoadjuvant chemotherapy and adjuvant CPI therapy-have been evaluated in addition to chemoradiation. Furthermore, antibody-drug conjugates, such as tisotumab-vedotin, represent a promising future therapeutic option for recurrent cervical cancer."

Journal • Review • Cervical Cancer • Gynecology • Oncology • Solid Tumor • Urinary Incontinence • Urology • PD-L1

New developments in the treatment of cervical cancer in 2026. (PubMed, Curr Opin Obstet Gynecol) - "These developments reflect a shift toward precision medicine that integrates immunotherapy, antiangiogenic, and targeted agents; however, challenges persist in optimizing treatment sequences, overcoming resistance, and identifying biomarkers to personalize care. Addressing global disparities in prevention and treatment access remains essential to achieving the WHO's goal of eliminating cervical cancer by 2030."

IO biomarker • Journal • Cervical Cancer • Oncology • Solid Tumor • HER-2 • MSLN • NECTIN4

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 2 December 2025, approved tisotumab vedotin (Tivdak) used for the treatment of adults with cervical cancer that has come back or spread. (GOV.UK) - "It is used if the disease worsened after previous anti-cancer treatment. Tisotumab vedotin is administered via an intravenous infusion (drip) into the vein over 30 minutes once every three weeks."

MHRA approval • Cervical Cancer

A case of metachronous cervical and early-stage breast cancer. (PubMed, Discov Oncol) - "The simultaneous or sequential presentation of cervical and breast cancer is rare, especially under systemic treatment. The patient's cervical cancer was aggressive, and the subsequent metachronous breast cancer highlights the complex, multifactorial nature of carcinogenesis. The development of a second primary malignancy while a patient is receiving treatment for a metastatic condition is a critical clinical scenario, necessitating individualized treatment strategies, as optimal management remains unclear due to the rarity of such cases."

Journal • Breast Cancer • Cervical Cancer • Gynecology • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20) (clinicaltrials.gov) - P3 | N=686 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Oct 2028 ➔ Jun 2028 | Trial primary completion date: Oct 2028 ➔ Jun 2028

Monotherapy • Trial completion date • Trial primary completion date • Cervical Cancer • Oncology • Solid Tumor

Tisotumab Vedotin in Second- or Third-Line Recurrent or Metastatic Cervical Cancer: Subsequent Therapy Data From ENGOT-cx12/GOG-3057/innovaTV 301 (DGHO 2025) - P3 | "Eligible pts had r/mCC with disease progression on/after chemo doublet ± bevacizumab and an anti–PD-(L)1 agent, if eligible and available. Pts were randomized 1:1 to TV monotherapy (2.0 mg/kg every 3 wk) or investigator's choice of chemo (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed)... In innovaTV 301, a meaningful proportion of pts received subsequent anticancer therapy in both treatment arms, with cytotoxic chemo and immunotherapy as the most common choices. These data show that TV provides meaningful clinical benefit and does not prevent pts from receiving subsequent therapies, including immunotherapy."

Metastases • Cervical Cancer • Oncology • Solid Tumor

Anticipated Major Milestones in the Fourth Quarter of 2025 and Full Year 2026:…Upcoming Potential NMPA Approvals (Businesswire) - "(i) Tisotumab Vedotin (Tissue Factor ADC) in recurrent or metastatic cervical cancer following progression on or after chemotherapy; (ii) Repotrectinib (ROS1/TRK) in NTRK+ solid tumors."

China approval • Cervical Cancer

Assessing the mechanism of action (MOA) of tisotumab vedotin (TV) in head and neck squamous cell carcinoma (HNSCC) with digital pathology analysis of H&E images from innovaTV207 part C (SITC 2025) - P2 | "Medical writing assistance, funded by Pfizer according to Good Publication Practice guidelines, was provided by Akshaya Srinivasan, PhD, CMPP, of Nucleus Global, an Inizio Company.Trial Registration ClinicalTrials.gov ID, NCT03485209Ethics Approval All patients provided informed consent before taking part in the study. Independent ethics committee or institutional review board approval was obtained for each study site (IRB number at first enrolling site, 22-312; IRB registration number, 00001230)."

Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Zai Lab Announces Fourth Quarter and Full Year 2024 Financial Results and Recent Corporate Updates (Businesswire) - "Tisotumab Vedotin (Tissue Factor ADC): BLA submission in recurrent or metastatic cervical cancer following progression on or after chemotherapy in the first quarter of 2025. Bemarituzumab (FGFR2b): BLA submission in first-line gastric cancer in the first half of 2025. Repotrectinib (ROS1/TRK): supplementary NDA submission in NTRK+ solid tumors in the first half of 2025. Tumor Treating Fields (TTFields): Marketing Authorization Application submissions in second-line+ NSCLC following progression on or after platinum-based chemotherapy and in first-line pancreatic cancer...Second-Line+ Extensive-Stage SCLC (ES-SCLC): Zai Lab to present updated data at a major medical conference in the first half of 2025. Zai Lab plans to initiate a pivotal study in 2025...Other neuroendocrine tumors: Zai Lab to initiate a global Phase 1 study in the first half of 2025...ZL-6201 (LRRC15 ADC): Zai Lab to provide preclinical data update and initiate a global Phase 1 study in sarcoma."

China filing • Clinical data • New P1 trial • Preclinical • Cervical Cancer • Gastric Cancer • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Sarcoma • Small Cell Lung Cancer • Solid Tumor

Development and application of antibody-drug conjugates in gynecological cancers. (PubMed, Sci China Life Sci) - "Their clinical applications and associated challenges have also been highlighted. Finally, we discuss the prospects of ADCs in the treatment of gynecological cancers."

Journal • Review • Cervical Cancer • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • Women's Health

Zai Lab Announces Second Quarter 2025 Financial Results and Recent Corporate Updates (Businesswire) - "Upcoming Potential NMPA Submissions: Bemarituzumab (FGFR2b) in first-line gastric cancer in the second half of 2025. Upcoming Potential NMPA Approvals: Tisotumab Vedotin (Tissue Factor ADC) in recurrent or metastatic cervical cancer following progression on or after chemotherapy; Repotrectinib (ROS1/TRK) in NTRK+ solid tumors."

China approval • China filing • Cervical Cancer • Gastric Cancer • Solid Tumor

Exposure-safety Markov modeling of ocular adverse events in patient populations treated with tisotumab vedotin. (PubMed, J Pharmacokinet Pharmacodyn) - P1/2, P2 | "A total of 757 patients who received TV as monotherapy or combination (with carboplatin, bevacizumab, or pembrolizumab) across seven clinical studies were included in this analysis. Based on the totality of data from clinical outcomes, pharmacokinetics, and E-R analyses, as well as DTMM modeling results, TV 1.7 mg/kg every 2 weeks may provide higher efficacy with slightly increased risk of OAEs compared with 2.0 mg/kg Q3W, although these OAEs are manageable with an appropriate eye care plan. ClinicalTrials.gov ID (first submission): NCT03485209 (2018-03-08), NCT03657043 (2018-08-22), NCT03438396 (2018-02-08), NCT03786081 (2018-12-13), NCT03913741 (2019-03-29), NCT02001623 (2013-11-14), and NCT02552121 (2015-09-14)."

Adverse events • Journal • Cervical Cancer • Oncology • Solid Tumor

Tisotumab vedotin plus carboplatin or pembrolizumab in recurrent or metastatic cervical cancer: 5-year results from the innovaTV 205/GOG-3024/ENGOT-cx8 study (ESMO 2025) - P1/2 | "No new safety signals were observed. Further investigation of these TV-doublets in r/mCC is warranted."

Metastases • Cervical Cancer • Oncology • Solid Tumor

KEYNOTE-E02: Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors (clinicaltrials.gov) - P2 | N=352 | Active, not recruiting | Sponsor: Seagen, a wholly owned subsidiary of Pfizer | Trial primary completion date: Sep 2025 ➔ Jan 2026

Trial primary completion date • Colorectal Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Antibody-Drug Conjugates for the Treatment of Gynecologic Cancer: A Review of the Current Evidence and Clinical Application. (PubMed, Hematol Oncol Clin North Am) - "Two of these drugs are currently approved for treatment of gynecologic cancers and many more are under investigation. Along with the expected toxicities associated with chemotherapy drugs, antibody-drug conjugates can cause more atypical adverse events; the treating oncologist should be aware of these toxicities and their management."

Journal • Review • Cervical Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

TROFUSE-020/GOG-3101/ENGOT-CX20: A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OPEN-LABEL, MULTICENTER STUDY COMPARING SACITUZUMAB TIRUMOTECAN MONOTHERAPY VS TREATMENT OF PHYSICIAN'S CHOICE AS SECOND-LINE TREATMENT FOR RECURRENT/METASTATIC CERVICAL CANCER (IGCS 2025) - P3 | " Eligible participants are aged ≥18 years with progressive recurrent/metastatic cervical cancer, measurable per RECIST v1.1 by investigator, and had received 1 line of platinum doublet chemotherapy (±bevacizumab) and anti‒PD-1/anti‒PD-L1 therapy as a part of cervical cancer regimens...Approximately 666 participants will be randomly assigned 1:1 to receive sac-TMT 4 mg/kg IV Q2W or TPC (pemetrexed 500 mg/m2 IV Q3W; tisotumab vedotin 2 mg/kg IV Q3W; 3-week cycles of topotecan 1 or 1.25 mg/m2 on days 1‒5, vinorelbine 30 mg/m2 on days 1 and 8, gemcitabine 1000 mg/m2 on days 1 and 8; or 6-week cycles of irinotecan 100 or 125 mg/m2 on days 1, 8, 15, and 22)...Current Status & Future Directions: Enrollment began Q3 2024. Results will determine the efficacy and safety of sac-TMT."

Clinical • Metastases • Monotherapy • P3 data • Cervical Cancer • Oncology • Solid Tumor

Hematological toxicity of anti-tumor antibody-drug conjugates: A retrospective pharmacovigilance study using the FDA adverse event reporting system. (PubMed, PLoS One) - "ADCs are significantly associated with increased reporting of hematotoxicity. A novel hematotoxicity signal that was not disclosed in the drug specifications was observed. The most prominent hematotoxicity AE signals were cytopenia related to inotuzumab ozogamicin (IO), polatuzumab vedotin (PV), loncastuximab tesirine (LT), and tisotumab vedotin (TV); febrile bone marrow aplasia related togemtuzumab ozogamicin (GO), BV, and SG; and myelosuppression related to BV, trastuzumab emtansine (TE), andenfortumab vedotin (EV). Our findings need to be validated by large-scale prospective studies."

Adverse events • Journal • Retrospective data • Aplastic Anemia • Hematological Disorders • Oncology

PATIENT-REPORTED OUTCOMES FROM THE PHASE 3 ENGOT-CX12/GOG-3057/INNOVATV 301 TRIAL OF TISOTUMAB VEDOTIN AS SECOND/THIRD-LINE TREATMENT FOR RECURRENT OR METASTATIC CERVICAL CANCER (IGCS 2025) - P3 | "Models controlled for baseline ECOG PS, prior bevacizumab, and prior anti–PD-1/PD-L1 therapy. A total of 198 patients in the TV arm and 158 in the chemotherapy arm completed ≥1 post-baseline PRO questionnaire. A total of 198 patients in the TV arm and 158 in the chemotherapy arm completed ≥1 post-baseline PRO questionnaire. Global health status (QLQ-C30) was maintained from baseline to cycle 13 in both arms (Fig.1). Time to clinically meaningful worsening was generally more favorable among patients in the TV arm compared with the chemotherapy arm across key domains for both the QLQ-C30 and QLQ-CX24 instruments (Fig."

Clinical • Metastases • P3 data • Patient reported outcomes • Cervical Cancer • Oncology • Solid Tumor

Advancing Care in Cervical Cancer: The Role of Tisotumab Vedotin (ESMO 2025) - "Sponsored by Genmab"

Cervical Cancer • Oncology • Solid Tumor

Breakthrough clinical research conducted by Florida Cancer Specialists & Research Institute, LLC (FCS) will be in the spotlight this week in Berlin at the European Society of Medical Oncology (ESMO) Congress 2025. (PRNewswire) - "Among the 23 studies co-authored by FCS physician investigators selected for presentation to oncology experts worldwide, one has earned the distinction of being featured as an oral presentation and four as poster presentations by FCS first authors."

Clinical data • Platinum resistant • pMMR • Cervical Cancer • Endometrial Cancer • Ovarian Cancer • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Genomics of cervical, vulvar and vaginal cancers and the potential of precision medicine. (PubMed, Ther Adv Med Oncol) - "For cervical, vulvar and vaginal cancers specifically, trastuzumab deruxtecan and tisotumab vedotin could be important therapeutic options in the right context. In this review, we describe the molecular features of different cervical, vulvar and vaginal cancer types, current genomically-matched therapies being investigated and discuss treatment strategies with future potential."

Journal • Review • Cervical Adenocarcinoma • Cervical Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gynecologic Cancers • Infectious Disease • Melanoma • Oncology • Rare Diseases • Solid Tumor • Squamous Cell Carcinoma • Vaginal Cancer • Vulvar Cancer • TGFB1

Advanced Antibody-Drug Conjugates Design: Innovation in Linker Chemistry and Site-Specific Conjugation Technologies. (PubMed, Chembiochem) - "Several ADCs have been approved for clinical use in oncology, including Mylotarg, Adcetris, Kadcyla, Besponsa, Polivy, Lumoxiti, Padcev, Enhertu, Trodelvy, Aidixi, Zynlonta, Tivdak, Elahere, Datroway, and Emrelis. The toxicity profiles of ADCs and strategies are also addressed to mitigate off-target effects and systemic toxicity. Overall, this review provides a comprehensive overview of the current state of linker and conjugation technologies in ADC development."

Journal • Review • Oncology