Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 68 |
| INN | Tisotumab vedotin |
| Status | Approved |
| Drug code(s) | HuMax-TF-ADC |
| Brand name | TIVDAK |
| mAb sequence source | mAb human |
| General Molecular Category | ADC |
| Format, general category | Full length Ab conjugate |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | Valine-Citrulline, Cleavable linker |
| Ave. DAR | 4 |
| Conjugated/fused moiety | Tubulin inhibitor, Monomethyl auristatin E (MMAE) |
| Discovery method/technology | Transgenic mouse (GenPharm/Medarex/BMS transgenic mouse platform) |
| Target(s) | Tissue factor |
| Indications of clinical studies | Cervical cancer, Solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved US |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 18, 2013 |
| Start of Phase 2 | August 10, 2017 |
| Start of Phase 3 | December 15, 2020 |
| Date BLA/NDA submitted to FDA | February 10, 2021 |
| Year of first approval (global) | 2021 |
| Date of first US approval | September 20, 2021 |
| INN, US product name | Tisotumab vedotin, tisotumab vedotin-tftv |
| US or EU approved indications | Treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. |
| Company | Genmab |
| Licensee/Partner | Seagen Inc. |
| Comments about company or candidate | Feb 2, 2024: Genmab A/S and Pfizer, Inc. announced that the European Medicines Agency (EMA) has validated for review the marketing authorization application (MAA) of tisotumab vedotin, an antibody-drug conjugate (ADC), developed for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy. September 20, 2021 – Genmab A/S (Nasdaq: GMAB) and SeagenInc. (Nasdaq: SGEN) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to TIVDAKTM (tisotumab vedotin-tftv), April 9, 2021: Genmab A/Sand Seagen Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) seeking accelerated approval for tisotumab vedotin. This BLA requests FDA approval of tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of Oct 10, 2021. Feb 10, 2021 – Genmab A/S (Nasdaq: GMAB) and Seagen Inc. (Nasdaq: SGEN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for tisotumab vedotin. This BLA requests FDA approval of tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The submission is based on the results of the innovaTV 204 pivotal phase 2 single-arm clinical trial evaluating tisotumab vedotin as monotherapy in this setting. The topline results from the phase 2 study were announced in June 2020 and data were presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) directed to tissue factor (TF), a cell-surface protein expressed on multiple solid tumors including cervical cancer and is associated with tumor growth, angiogenesis, metastasis and poor prognosis. Jan 2021: Genmab A/S announced the initiation of innovaTV 301 trial (NCT04697628), a global phase 3 study to evaluate the efficacy of tisotumab vedotin compared to chemotherapy in patients with recurrent or metastatic cervical cancer who have received one or two prior lines of systemic therapy. Sep 2020: Genmab A/S and Seattle Genetics, Inc. presented data from the innovaTV 204 pivotal phase 2, single-arm clinical trial evaluating tisotumab vedotin as monotherapy in patients with previously treated recurrent and/or metastatic cervical cancer at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. Patients had previously received a doublet chemotherapy and, if eligible, bevacizumab as first-line therapy. Results from the trial showed a 24 percent confirmed objective response rate (ORR) by independent central review with a median duration of response (DOR) of 8.3 months. Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. “Based on these results, we look forward to submitting a Biologics License Application to the FDA under the accelerated approval pathway.” July 2019: Tisotumab Vedotin innovaTV 204 Pivotal Trial Data Expected in 2020: Seattle Genetics and Genmab previously reported the completion of enrollment in the innovaTV 204 pivotal trial of tisotumab vedotin in patients with recurrent and/or metastatic cervical cancer who have relapsed or progressed after standard of care treatment. Topline data from the trial are expected in the first half of 2020. The trial is intended to support potential regulatory submission under the FDA's accelerated approval pathway. http://investor.seattlegenetics.com/static-files/fc8c8fc2-e675-48d3-958b-fef297f2e7bc. Feb 2019: Results of Phase 1/2 study published in Lancet Oncology. InnovaTV 201 is a phase 1–2, open-label, dose-escalation and dose-expansion study done at 21 centres in the USA and Europe. In this study tisotumab vedotin had a manageable safety profile with encouraging preliminary antitumour activity across multiple tumour types in heavily pretreated patients. (DOI:https://doi.org/10.1016/S1470-2045(18)30859-3). June 2018: Phase 2 study in cervical cancer started. Oct. 10, 2017-- Genmab A/S and Seattle Genetics, Inc. announced today a decision to start a Phase II study of tisotumab vedotin in patients with recurrent and/or metastatic cervical cancer. The study could provide the basis for a regulatory application for approval. June 2017: Genmab A/S (Nasdaq Copenhagen: GEN) announced today preliminary data from the ongoing Phase I/II study of tisotumab vedotin in solid tumors (GEN701). In Part 2 of the study, 11 of 34 evaluable patients in the cervical cancer cohort achieved a response; with a median time of treatment of 4.9 months, 7 responders are still ongoing or in follow up for progression. The safety profile of tisotumab vedotin was consistent with known MMAE based antibody-drug conjugates (ADC). NCT02552121 Phase 1 due to start in Oct 2015. IND filed in July 2013 |
| Full address of company | Copenhagen, Denmark Europe Denmark https://www.genmab.com/ |
Tisotumab vedotin is an antibody-drug conjugate composed of a human IgG1 antibody targeting tissue factor conjugated to the microtubule-disrupting agent monomethyl auristatin E via a protease-cleavable linker.
| Anticipated events | Regulatory review in EU |
| Factor(s) contributing to discontinuation | None |