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

Alopecia in cancer immunotherapy: Incidence and patterns with monoclonal antibodies and antibody-drug conjugates (AACR 2026) - "Antibody-drug conjugates (ADCs), including datopotamab deruxtecan, trastuzumab deruxtecan, tisotumab vedotin, enfortumab vedotin, and disitamab vedotin, showed the highest rates of alopecia, ranging from 37% to 56% (predominantly grade 1-2)...In contrast, immune checkpoint inhibitors such as cemiplimab (anti-PD-1) and trastuzumab (anti-HER2) were rarely associated with alopecia (1-2.2% incidence, grade 1-2) in lung and breast cancer patients, respectively...In contrast, antibody-only and interferon therapies demonstrated substantially lower rates (1-28%). Recognizing these trends across biologic classes can help clinicians set patient expectations, guide counseling, and implement supportive measures for those experiencing hair loss throughout treatment."

ADC • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • IFNAR2 • TOP1

Cutaneous Adverse Reactions and Antibody-Drug Conjugates: A FAERS 2019-2025 Disproportionality Analysis (AAD 2026) - "CARs were disproportionally reported with enfortumab vedotin (ROR = 3.92 [3.84-4.00] for any CAR and ROR = 3.49 [3.32 – 3.66] for SCAR) and loncastuximab tesirine (ROR = 2.85 [2.47-3.28] for CAR). Although it is still early to report pharmacovigilance data on the newest ADCs, we found early signals of cutaneous adverse events in FAERS with tisotumab vedotin (ROR 1.53 [1.31-1.79] which was approved in 2024. Continued surveillance of this class is important moving forward."

ADC • Steven-Johnson Syndrome • ROR1

ONM-421, a pH-responsive polymer-drug conjugate nanoparticle, delivers MMAE to solid tumors and shows antigen-independent antitumor efficacy in mice (AACR 2026) - "Efficacy and tolerability of ONM-421 was studied in vivo in multiple human xenograft models, HT-29, HCT-116, and FaDu compared to docetaxel (DTX) and a tissue factor targeting MMAE-ADC tisotumab vedotin (TV). ONM-421 showed stable uniformly distributed size (Dh<50nm), <1% free MMAE, and consistent pH-responsiveness over a 6-month ongoing storage stability study. ONM-421 demonstrated potent antigen-independent antitumor efficacy in multiple xenograft tumors with good tolerability in mice. The data justifies further development of ONM-421 towards IND-enabling studies."

Preclinical • Oncology • Solid Tumor • CTSB

Tisotumab vedotin in combination with carboplatin and pembrolizumab with or without bevacizumab in first-line recurrent or metastatic cervical cancer: first disclosure of arm H from the ENGOT-cx8/GOG-3024/innovaTV 205 study (SGO 2026) - No abstract available

Clinical • Combination therapy • Metastases • Cervical Cancer • Oncology • Solid Tumor

KEYNOTE-E02: Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Seattle Genetics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Gastrointestinal 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

Early use of adcs in gynecological oncology – a case report based on metastatic cervical cancer (ESGO 2026) - "First line therapy is platinum-based chemotherapy with Paclitaxel +/- bevacizumab and +/- pembrolizumab in PD-L1 positive tumors (CPS ≥ 1) followed by Tisotumab vedotin or chemotherapy.Methodology This case report deals with a 31-year-old woman with de novo metastatic squamous-cell carcinoma of the cervix (PUL, LYM) with early progress on three cycles first-line platinum-based chemotherapy.Results Patient had cervical biopsy in february 2025...Dual chemotherapy with carboplatin and paclitaxel q3w was started...CT-Scan after 3 cycles of chemotherapy showed progressive disease with progredient (PUL, LYM) and new metastases (PER, OSS).Having no alternatives of immuncheckpointinhibitors therapies and targeted therapies, tumorboard recommended an off-label-use (individual therapy) of ADC Trastuzumab deruxtecan (T-DXd), facing the results of DESTINY-PanTumor01-Study in metastatic solid tumors with specific activating HER2 mutations.For symptomatic treatment of vaginal..."

Case report • Clinical • IO biomarker • Metastases • Cervical Cancer • Gynecologic Cancers • Oncology • Solid Tumor • Squamous Cell Carcinoma • HER-2 • PD-L1

KEYNOTE-E02: Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors (clinicaltrials.gov) - P2 | N=692 | Recruiting | Sponsor: Seagen Inc. | Trial primary completion date: Apr 2025 ➔ Feb 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

KEYNOTE-E02: Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors (clinicaltrials.gov) - P2 | N=692 | Recruiting | Sponsor: Seagen Inc. | N=532 ➔ 692 | Trial completion date: Dec 2024 ➔ Nov 2026

Enrollment change • Trial completion date • Colorectal Cancer • Gastrointestinal 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

KEYNOTE-E02: Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors (clinicaltrials.gov) - P2 | N=392 | Recruiting | Sponsor: Seagen Inc. | N=250 ➔ 392 | Trial completion date: May 2022 ➔ Apr 2024 | Trial primary completion date: Jun 2021 ➔ May 2022

Enrollment change • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal 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

KEYNOTE-E02: Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Seattle Genetics, Inc.

New P2 trial • Colorectal Cancer • Gastrointestinal 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

KEYNOTE-E02: Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors (clinicaltrials.gov) - P2 | N=352 | Active, not recruiting | Sponsor: Seagen Inc. | Recruiting ➔ Active, not recruiting | N=692 ➔ 352

Enrollment change • Enrollment closed • 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

KEYNOTE-E02: Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors (clinicaltrials.gov) - P2 | N=250 | Recruiting | Sponsor: Seattle Genetics, Inc. | Trial completion date: Apr 2021 ➔ May 2022 | Trial primary completion date: Apr 2020 ➔ Jun 2021

Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal 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 of Head and Neck • Thoracic Cancer • PD-L1

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

Trial completion date • 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

KEYNOTE-E02: Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors (clinicaltrials.gov) - P2 | N=692 | Recruiting | Sponsor: Seagen Inc. | Trial primary completion date: Nov 2023 ➔ Apr 2025

Trial primary completion date • Colorectal Cancer • Gastrointestinal 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

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

KEYNOTE-E02: Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors (clinicaltrials.gov) - P2 | N=532 | Recruiting | Sponsor: Seagen Inc. | N=392 ➔ 532 | Trial completion date: Apr 2024 ➔ Dec 2024 | Trial primary completion date: May 2022 ➔ Nov 2023

Enrollment change • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal 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

ADCE-T02 - A clinical stage antibody drug conjugate targeting tissue factor demonstrates strong efficacy in preclinical models of head and neck squamous cell carcinoma (AACR 2026) - P1 | "The TF-targeted ADC Tisotumab vedotin is approved for treatment of cervical cancer and has demonstrated efficacy in Head and Neck Squamous Cell Carcinoma (HNSCC)1, but treatment is limited by substantial side effects including ocular toxicities, peripheral neuropathy, and bleeding warranting development of a more efficacious and better tolerated modality.ADCE-T02 is a clinical stage TF-targeted ADC composed of a humanized anti-TF antibody specifically designed to limit the impact on blood coagulation, conjugated via a novel T1000 linker moiety to the Topoisomerase-1 inhibitor Exatecan payload at a drug-to-antibody ratio of ~4.The expression level of TF was evaluated in patients with HNSCC, confirming broad and high TF expression in the majority of tumors, regardless of Human Papilloma Virus (HPV) status. A phase I clinical study of ADCE-T02 in patients with advanced solid tumors is currently ongoing and actively recruiting (Clinical Trial ID NCT06597721).1Sun et..."

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

Tissue Factor expression is associated with B7-H4-mediated immune evasion in ovarian clear cell carcinoma and with response to tisotumab vedotin in preclinical models (AACR 2026) - "TF-high OCCC shows a distinct gene expression pattern, particularly an immunologically cold subtype with B7-H4-mediated immune evasion. TV demonstrates TF-dependent activity, supporting TF as a therapeutic target, and providing rationale for TV-based monotherapy or combinations with immunotherapy in OCCC."

IO biomarker • Preclinical • Clear Cell Carcinoma • Oncology • Ovarian Cancer • MYC • VTCN1

STRO-004, an exatecan-based next-generation tissue factor (TF)-targeted ADC, demonstrates superior efficacy across TF-expressing solid tumors in a comprehensive single-mouse PDX trial (AACR 2026) - P1 | "Although TF-targeted antibody–drug conjugates (ADCs) such as tisotumab vedotin have demonstrated clinical activity, their utility is limited by on-target/off-tumor and systemic, platform toxicities associated with premature payload release. Because the single-mouse PDX trial design better reflects patient diversity in human trials, these results provide strong support for STRO-004 as a potential best-in-class TF-targeted ADC. The first-in-human Phase 1 study of STRO-004 is ongoing in solid tumor indications that are expected to have high TF expression or prevalence (NCT07227168)."

ADC • First-in-human • Preclinical • Cervical Cancer • Colorectal Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Preclinical Activity of Tisotumab Vedotin, an Antibody Drug Conjugate targeting Tissue Factor, in primary Uterine Serous Carcinoma Cell Lines and Xenografts (SGO 2026) - No abstract available

ADC • Preclinical • Endometrial Serous Adenocarcinoma • Oncology • Uterine Cancer

Does prior radiation affect response? Assessment of tisotumab-vedotin activity in recurrent cervical cancer (SGO 2026) - No abstract available

Cervical Cancer • Oncology • Solid Tumor

Genmab's recently approved therapy for cervical cancer that has come back or spread, Tivdak, has been turned down for NHS use in initial guidance from reimbursement authority NICE. (pharmaphorum) - "The green light came on the strength of the phase 2 innovaTV 301 study, which revealed median overall survival (OS) was 11.5 months with the new therapy compared with 9.5 months in a chemotherapy control arm, equivalent to an approximately 30% reduction in the risk for death."

NICE • Cervical Cancer

Molecular Targets of Cervical Cancer and Its Microenvironment: Advances in Treatment. (PubMed, Cancers (Basel)) - "For instance, Bevacizumab, a monoclonal antibody targeting angiogenesis factors, as well as Endostar, a recombinant human endostatin, have been studied and shown to improve survival in advanced disease...Furthermore, antibody-drug conjugates such as Tisotumab Vedotin allow to deliver a highly toxic payload directly to the tumor site by binding to tissue factor, which is highly expressed in cervical tumor cells...However, more robust clinical trials are needed before these vaccines can be effectively and safely used clinically. Finally, several ongoing trials are currently evaluating new therapeutic modalities and combinations of the currently available tools in the cervical cancer treatment armamentarium."

Journal • Review • Cervical Cancer • Oncology • Solid Tumor

Antibody-Drug Conjugates in Gynecologic Oncology at a tertiary cancer center – Real-World Data on Side Effects of Mirvetuximab soravtansine and Tisotumab vedotin at the LMU Department of Obstetrics and Gynecology (DKK 2026) - "Effective side effect management, interdisciplinary education and collaboration, and early supportive interventions are essential for successful therapy administration. Some side effects may present after treatment discontinuation, highlighting the need for prolonged monitoring."

Adverse events • Clinical • Real-world • Real-world evidence • Cervical Cancer • Conjunctivitis • Dry Eye Disease • Epithelial Ovarian Cancer • Gynecologic Cancers • Gynecology • Keratitis • Obstetrics • Ocular Infections • Ocular Inflammation • Oncology • Ophthalmology • Ovarian Cancer

Antibody-Drug Conjugates in Gynecologic Oncology: Advances, Challenges, and Future Directions. (PubMed, BioDrugs) - "Currently, three ADCs have received Food and Drug Administration (FDA) approval for use in gynecologic malignancies: mirvetuximab soravtansine, tisotumab vedotin, and trastuzumab deruxtecan. Furthermore, the inherent complexities of these drugs and their mechanisms of action underscore the need for further research into the relevance of biomarkers, methods of therapy resistance, and the potential for re-utilization of payloads and targets later in the disease course. This review focuses on the mechanisms of action of ADCs, their developmental trajectory, successes in gynecologic cancers, emerging areas of investigation, the prospective landscape, and current challenges in the field."

Journal • Review • Gynecologic Cancers • Oncology • Pneumonia • CDH6 • VTCN1