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Rigshospitalet - a part of Copenhagen University Hospital

Tisotumab Vedotin in Previously Treated Recurrent or Metastatic Cervical Cancer

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  • David S Hong
  • Nicole Concin
  • Ignace Vergote
  • Johann S de Bono
  • Brian M Slomovitz
  • Yvette Drew
  • Hendrik-Tobias Arkenau
  • Jean-Pascal Machiels
  • James Spicer
  • Robert Jones
  • Martin Forster
  • Nathalie Cornez
  • Christine Gennigens
  • Melissa L Johnson
  • Fiona C Thistlethwaite
  • Reshma A Rangwala
  • Srinivas Ghatta
  • Kristian Windfeld
  • Jeffrey R Harris
  • Ulrik Niels Lassen
  • Robert L Coleman
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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 1/2 study (NCT02001623).

EXPERIMENTAL DESIGN: 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+doublet chemotherapy. 51% 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: 1.0+-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: 1.0+-9.7), and 6-month PFS rate of 40% (95% CI: 24%-55%). TF 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
JournalClinical Cancer Research
Issue number6
Pages (from-to)1220-1228
Number of pages9
Publication statusPublished - 15 Mar 2020

Bibliographical note

©2019 American Association for Cancer Research.

ID: 58969994