The advent of enfortumab vedotin plus pembrolizumab (EV/P) has marked a significant advancement in the treatment of metastatic urothelial cancer (mUC). The results from the EV-302 study demonstrated remarkable efficacy in improving overall survival. While the efficacy of EV/P is undeniable, its toxicity profile, particularly concerning neuropathy and skin conditions, limits its applicability. To more accurately identify patients unsuitable for EV/P, the EV-Ineligible criTeriA (EVITA) is proposed as criterion for EV eligibility. Currently, there's a lack of data regarding the EVITA population in real-world clinical practice. Therefore we are retrospectively analyzing our patients that have used EV, and using the EVITA criteria to determine what patients may have had adverse reactions.

We performed a retrospective analysis of patients with metastatic urothelial carcinoma who underwent treatment with either enfortumab vedotin and pembrolizumab, or enfortumab vedotin alone. Patients received a fixed dose of 60mg of enfortumab vedotin, with 200mg of pembrolizumab added when applicable. Baseline characteristics, side effects, and CTCAE grading were examined. The primary endpoints were to evaluate whether the EVITA criteria could predict the incidence and severity of adverse events. Additionally, response rate and progression-free survival (PFS) were analyzed in relation to the EVITA criteria.

This retrospective analysis included 57 patients with metastatic urothelial carcinoma treated with either enfortumab vedotin and pembrolizumab, or enfortumab vedotin alone. Seventeen patients had EVITA scores ≥2, while 40 patients had scores <2. In the EVITA ≥2 group, 3 of 17 patients (17.6%) experienced Grade 2 or higher adverse events (AEs), compared to the EVITA <2 group, where the proportion of Grade 2 or higher AEs was observed in the EVITA <2 group, however, the difference did not reach statistical significance (P=0.5). Objective response rates were 35.0% in the EVITA <2 group and 35.3% in the EVITA ≥2 group, with no statistically significant difference.

In conclusion, the EVITA criteria may have the potential for predicting adverse events associated with reduced-dose enfortumab vedotin treatment in an Asian population. The lack of statistical significance in this study might be attributed to the limited sample size. However, our findings suggest that the EVITA criteria do not appear to effectively predict treatment response. These findings warrant further investigation in larger, prospective studies.