Genmab — Oktober 2018

[E_L]

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.

[E_L]

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.

[E_L]

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

[E_L]

response was 4.9 months and median PFS was 4.2 months by IIR.

[E_L]

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.

[E_L]

(End)

[Bulder]

Tak E L.
41% ORR heraf 1 CR - er det godt?

[Bulder]

Tyder på bedre responsrate end i rapporten fra sidste år (32%)

[Darvin]

Thanks E L - lidt forvirret. ORR er højere end sidst men median ser ud til at være kortere.

[JørgenVarnæs]

Kom N=34 resultaterne ikke fra dose eskaleringen_

[Bulder]

Hvad var responsvarigheden sidst?

[E_L]

So, standard of care beyond 1L treatment and 2L response rates of ∼13%

[E_L]

Last year n=34, investigator assessed ORR 32% (26% confirmed) median age 44

[E_L]

Now n=55, investigator assessed ORR 41% (24% confirmed) median age 47

[Bulder]

Do you happen to know the duration of response last year?

[Bulder]

Nevertheless, 41% is far better than 13%

[Bulder]

The 41% ORR was found by IIR (independent imaging review ) and not INV as far as I can see.

[E_L]

found last year https://oncologypro.esmo.org/Meeting-Resources/ESMO-2017-Congress/A-Phase-IIa-Study-of-Tisotumab-Vedotin-HuMax-R-TF-ADC-in-Patients-With-Relapsed-Recurrent-and-or-Metastatic-Cervical-Cancer

[E_L]

10.34 you are correct

[bibob]

@Bulder. - whats the different. ?