Tisotumab Vedotin in Previously Treated Recurrent or Metastatic Cervical Cancer.
Clin Cancer Res
; 26(6): 1220-1228, 2020 03 15.
Article
en En
| MEDLINE
| ID: mdl-31796521
ABSTRACT
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 ANDMETHODS:
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. 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 1.0+-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%). 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.
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Oligopéptidos
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Carcinoma de Células Escamosas
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Neoplasias del Cuello Uterino
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Resistencia a Antineoplásicos
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Anticuerpos Monoclonales Humanizados
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Antineoplásicos Inmunológicos
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Recurrencia Local de Neoplasia
Tipo de estudio:
Clinical_trials
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Prognostic_studies
Límite:
Adult
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Aged
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Female
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Humans
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Middle aged
Idioma:
En
Revista:
Clin Cancer Res
Asunto de la revista:
NEOPLASIAS
Año:
2020
Tipo del documento:
Article