GU Cancers 2021 | UNITE: enfortumab vedotin in advanced urothelial cancer

The UNITE study is a large retrospective analysis of real-world experience with enfortumab vedotin, which of course is a new drug in advanced bladder cancer that we’re all very excited about. So the basis for UNITE was that since enfortumab was approved late in 2019 for advanced bladder cancer, it has been used pretty widely, both in academic medical centers, also some extent in the community. And we really wanted to capture the real-world experience with this drug to see on the one hand, how it compares with prior trial experiences because those can differ sometimes, and also, on the other hand, what is the efficacy and activity of this drug in populations that maybe were not included in clinical trials. Such as patients for instance with advanced comorbidities and other patients that the trials would have excluded. So, this retrospective study involves a total of, at this point we presented data on 12 different institutions, but it’s kind of continuously growing, at this point, we have quite a bit more.

We now have over 200 patients. The data presented in this study was on over 150 patients and specifically over 127 patients treated specifically with enfortumab vedotin monotherapy. We captured basically patient demographics, clinical characteristics, and specifically outcomes to treatment and additionally, also ,some adverse events.

In this abstract presented at ASCO GU 2021, we did not present adverse events but did present activity of enfortumab vedotin in various subsets of interests. And these include patients for instance, with advanced or metastatic bladder cancer and significant visceral metastases, for instance, liver metastases. Patients with advanced co-morbidities like diabetes, neuropathy, significantly reduced kidney, kidney dysfunction, so GFR under 30. Also, other subsets of interest, such as comparing activity in patients with primary tumor in the upper tract, versus primary bladder. Also, patients with FGFR3 mutations, which is a population for which of course another agent erdafitinib is approved.

What we found was that enfortumab was actually, on the one hand, the activity was consistent with what has been reported in clinical trials. We saw a response rate of actually over 50% and response rates were also maintained over all of these important subsets of interest. So we saw a significant responses in patients with again, very high burden of disease, including liver metastases, patients with primary bladder versus primary upper tract disease, patients with advanced co-morbidities as well, so significant kidney dysfunction, significant neuropathy, and a history of prior diabetes.

Also, we did see responses to enfortumab in patients with FGFR3 mutations, which again is an important population to define, I should say FGFR3 alterations, including mutations and fusions. And so that is, that remains a population of interest where we want to see how, what would be the appropriate sequence of treatment, for instance, erdafitinib vs enfortumab and that’s sort of potential future things to look at. And to conclude, UNITE is a growing database, so we continue to accrue sites and patients and update data and look forward to presenting more at future meetings. And then also as publishing in the manuscript, some of these data soon as well.