Genmab — Oktober 2018
-
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.
-
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
-
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.
-
Kom N=34 resultaterne ikke fra dose eskaleringen_
Hello! It looks like you're interested in this conversation, but you don't have an account yet.
Getting fed up of having to scroll through the same posts each visit? When you register for an account, you'll always come back to exactly where you were before, and choose to be notified of new replies (either via email, or push notification). You'll also be able to save bookmarks and upvote posts to show your appreciation to other community members.
With your input, this post could be even better 💗
Tilmeld Log ind