Article (Scientific journals)
Tisotumab Vedotin in Previously Treated Recurrent or Metastatic Cervical Cancer.
Hong, David S.; Concin, Nicole; Vergote, Ignace et al.
2020In Clinical cancer research : an official journal of the American Association for Cancer Research
Peer reviewed
 

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Keywords :
oncology
Abstract :
[en] 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.
Disciplines :
Oncology
Author, co-author :
Hong, David S.
Concin, Nicole
Vergote, Ignace
de Bono, Johann S.
Slomovitz, Brian M.
Drew, Yvette
Arkenau, Hendrik-Tobias
Machiels, Jean-Pascal
Spicer, James
Jones, Robert
Forster, Martin
Cornez, Nathalie
Gennigens, Christine  ;  Université de Liège - ULiège > Département des sciences cliniques > Département des sciences cliniques
Johnson, Melissa L.
Thistlethwaite, Fiona C.
Rangwala, Reshma A.
Ghatta, Srinivas
Windfeld, Kristian
Harris, Jeffrey R.
Lassen, Ulrik Niels
Coleman, Robert L.
More authors (11 more) Less
Language :
English
Title :
Tisotumab Vedotin in Previously Treated Recurrent or Metastatic Cervical Cancer.
Publication date :
2020
Journal title :
Clinical cancer research : an official journal of the American Association for Cancer Research
ISSN :
1078-0432
Peer reviewed :
Peer reviewed
Commentary :
Copyright (c)2019, American Association for Cancer Research.
Available on ORBi :
since 12 December 2019

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