Enfortumab Vedotin Combo Data in Urothelial Carcinoma Are ‘Compelling’

It may be “compelling” to use enfortumab vedotin-ejfv (Padcev) in combination with pembrolizumab (Keytruda) as a standard of care for those with metastatic urothelial carcinoma, said Amanda Nizam, MD, in a conversation with CancerNetwork^®.

Nizam, a genitourinary medical oncologist in the Department of Hematology and Oncology at Cleveland Clinic, spoke about data presented at the 2024 Genitourinary (GU) Cancers Symposium that support the enfortumab vedotin combination as a treatment for the aforementioned population, including subgroup analysis findings from the phase 3 EV-302 trial (NCT04223856). Results from that trial highlighted a progression-free survival benefit with the experimental regimen among those with visceral metastases (HR, 0.45; 95% CI, 0.37-0.55) as well as those with lymph node–only disease (HR, 0.40; 95% CI, 0.26-0.62), which were comparable with outcomes observed in the overall population (HR, 0.45; 95% CI, 0.38-0.54; P <.00001).^1,2

The FDA approved enfortumab vedotin plus pembrolizumab in locally advanced or metastatic urothelial carcinoma in December 2023.³

Transcript:

The data with EV-302 for [the enfortumab vedotin/pembrolizumab] combination are very strong across a lot of subgroups, as well. There's going to be more subgroups presented here at ASCO GU, as well. But those with visceral disease, those who need a quick response, and those with more than just lymph node–only disease are the patients who we would really choose enfortumab vedotin/pembrolizumab for. It's going to be [a question of] which patients should not be getting enfortumab vedotin/pembrolizumab or whom we choose platinum-based therapy for. Otherwise, enfortumab vedotin/pembrolizumab, based on the data itself, is very compelling to use as a standard of care as first-line therapy in metastatic [urothelial carcinoma].

References

1. Simon Van Der Heijden M, Powles T, Gupta S, et al. Enfortumab vedotin (EV) in combination with pembrolizumab (P) versus chemotherapy in previously untreated locally advanced metastatic urothelial carcinoma (la/mUC): Subgroup analyses results from EV-302, a phase 3 global study. J Clin Oncol. 2024;42(suppl 4):LBA530. doi:10.1200/JCO.2024.42.4_suppl.LBA530
2. Powles TB, Perez Valderrama B, Gupta S, et al. EV-302/KEYNOTE-A39: open-label, randomized phase III study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (Chemo) in previously untreated locally advanced metastatic urothelial carcinoma (la/mUC). Ann Oncol. 2023;34(suppl 2):S1340. doi:10.1016/j.annonc.2023.10.106
3. FDA approves enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial cancer. News release. FDA. December 15, 2023. Accessed January 29, 2024. https://bit.ly/48ls9bi