Tisotumab vedotin in previously treated recurrent or metastatic cervical cancer

David S. Hong, Nicole Concin, Ignace Vergote, Johann S. de Bono, Brian M. Slomovitz, Yvette Drew, Hendrik Tobias Arkenau, Jean Pascal Machiels, James F. Spicer, Robert Jones, Martin D. Forster, Nathalie Cornez, Christine Gennigens, Melissa L. Johnson, Fiona C. Thistlethwaite, Reshma A. Rangwala, Srinivas Ghatta, Kristian Windfeld, Jeffrey R. Harris, Ulrik Niels LassenRobert L. Coleman

Research output: Contribution to journalArticlepeer-review

19 Scopus citations


Purpose: Tissue factor (TF) is a potential target in cervical cancer, as it is frequently highly expressed and associated with poor prognosis. Tisotumab vedotin, a first-in-class investigational antibody-drug conjugate targeting TF, has demonstrated encouraging activity in solid tumors. Here we report data from the cervical cancer cohort of innovaTV 201 phase I/II study (NCT02001623). Patients and Methods: Patients with recurrent or metastatic cervical cancer received tisotumab vedotin 2.0 mg/kg every 3 weeks until progressive disease, unacceptable toxicity, or consent withdrawal. The primary objective was safety and tolerability. Secondary objectives included antitumor activity. Results: Of the 55 patients, 51% had received ≽2 prior lines of treatment in the recurrent or metastatic setting; 67% had prior bevacizumab þ doublet chemotherapy. Fifty-one percent of patients had squamous cell carcinoma. The most common grade 3/4 treatment-emergent adverse events (AEs) were anemia (11%), fatigue (9%), and vomiting (7%). No grade 5 treatment-related AEs occurred. Investigator-assessed confirmed objective response rate (ORR) was 24% [95% confidence interval (CI): 13%-37%]. Median duration of response (DOR) was 4.2 months (range: 1.0þ -9.7); four patients responded for >8 months. The 6-month progression-free survival (PFS) rate was 29% (95% CI: 17%-43%). Independent review outcomes were comparable, with confirmed ORR of 22% (95% CI: 12%-35%), median DOR of 6.0 months (range: 1.0þ-9.7), and 6-month PFS rate of 40% (95% CI: 24%-55%). Tissue factor expression was confirmed in most patients; no significant association with response was observed. Conclusions: Tisotumab vedotin demonstrated a manageable safety profile and encouraging antitumor activity in patients with previously treated recurrent or metastatic cervical cancer.

Original languageEnglish (US)
Pages (from-to)1220-1228
Number of pages9
JournalClinical Cancer Research
Issue number6
StatePublished - Mar 15 2020

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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