Biomarkers of Response With Enfortumab Vedotin in Advanced Urothelial Cancer

In the UNITE (Urothelial Cancer Network to Investigate Therapeutic Experiences) study, researchers looked at the experience with enfortumab vedotin (EV, Padcev) in patient subsets for which activity had not been well defined in clinical trials.

At the recent Genitourinary Cancers Symposium, new findings on biomarkers of response in the trial were presented by Tanya Jindal, BS, BA, of the Helen Diller Family Comprehensive Cancer Center at the University of California San Francisco. In this exclusive video, Jindal discusses the findings.

Following is a transcript of her remarks:

Enfortumab vedotin has been approved for treatment-refractory advanced urothelial carcinoma since late 2019. However, we have limited data regarding biomarkers that can predict outcomes with enfortumab vedotin treatment. So this is what we wanted to look at in this analysis, and specifically in the UNITE study.

So what we did is we looked at all the patients in the UNITE study that had advanced urothelial carcinoma and were treated with enfortumab vedotin monotherapy and also had next-generation sequencing results available. And we looked at the following biomarkers: tumor mutation burden (TMB), somatic alterations present in at least 10% of patients, as well as presence of one or more DNA damage response (DDR) mutations.

And then patients who had at least one cycle of EV and got scans afterwards were evaluable for response.

So some of the endpoints we looked at were objective response rate, and then also overall survival and progression-free survival from enfortumab vedotin treatment.