Genmab — Oktober 2018
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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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Conclusions
These data demonstrate that TV has encouraging activity in previously treated recurrent or metastatic cervical cancer, an underserved population with a high unmet need, and that responses observed with TV are numerically higher than those achieved by historical controls. These data support the continued investigation of TV in this population.
Clinical trial identification
NCT02001623.
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Kom N=34 resultaterne ikke fra dose eskaleringen_
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