Genmab — Oktober 2018
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God morgen.
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God morgen
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via this, but it is a pain in the neck...
https://cslide.ctimeetingtech.com/esmo2018/attendee/confcal/session/calendar?q=963p&r=st~19 -
Poster Display session
963P - A phase IIa study of tisotumab vedotin in patients with previously treated recurrent or metastatic cervical cancer: Updated analysis of full cervical expansion cohort
Presentation Number
963P
Lecture Time
12:30 - 12:30
Speakers
Nicole Concin (Parsippany, US)
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Background
Treatment options for recurrent or metastatic cervical cancer are limited, with no standard of care beyond 1L treatment and 2L response rates of ∼13%. Tisotumab vedotin (TV) is an antibody-drug conjugate comprised of a fully human monoclonal antibody specific for tissue factor (TF) conjugated to the microtubule disrupting-agent monomethyl auristatin E (MMAE) via a protease cleavable linker. TV is being evaluated in GEN701 (innovaTV 201), a Phase I/IIa dose-escalation and expansion
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study in patients (pts) with previously treated recurrent locally advanced or metastatic solid tumours. A previous report of the preliminary expansion cohort for cervical cancer (n = 34) showed an investigator (INV)-assessed response rate of 32% (26% confirmed) (Vergote et al., ESMO 2017 abstract #931O). INV response for the full cervical expansion cohort (N = 55) and response by independent imaging review (IIR) (n = 34) are presented here.
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Methods
Key eligibility criteria included recurrent or metastatic cervical cancer that progressed on standard therapy, adequate organ function and ECOG 0-1. TV 2 mg/kg Q3W was given until progression, toxicity or withdrawal. Activity and safety were assessed by RECIST 1.1 and CTCAE 4.03, respectively. Enrollment started in November 2015 and continued through May 2018.
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Results
The full cohort has 55 pts (median age was 47 y [21-74]). Updated efficacy by INV review, safety data, and response by TF expression will be presented. Median age in the first 34 pts was 44 y (21-74) and pts received a median of 2 prior lines for recurrent or metastatic disease. ORR by IIR of 41% (95% CI: 25%-59%), including 1 CR and 13 PR. 8 (1 CR, 7 PRs) were confirmed (24%; 95% CI: 11%-41%). Confirmed response rate was concordant between INV and IIR (26% and 24%). Median duration of
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