Jonathan E. Rosenberg, MD
Enfortumab vedotin-ejfv (Padcev) combined with pembrolizumab (Keytruda) led to an objective response rate (ORR) of 73% in previously untreated patients with locally advanced or metastatic urothelial cancer who were ineligible for cisplatin-based chemotherapy, according to updated results of the phase Ib/II EV-103 trial (NCT03288545) that will be presented during the 2020 Genitourinary Cancers Symposium.1,2
In December 2019, the FDA granted an accelerated approval to enfortumab vedotin for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received prior treatment with a PD-1/PD-L1 inhibitor and platinum-containing chemotherapy.
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- Seattle Genetics and Astellas announce updated results from phase 1b/2 trial of Padcev (enfortumab vedotin-ejfv) in combination with immune therapy pembrolizumab as investigational first-line treatment for advanced bladder cancer [news release]: Bothell, WA. Seattle Genetics, Inc., and Astellas Pharma, Inc. Published February 10, 2020. https://bit.ly/31MCDzi. Accessed February 11, 2020.
- Rosenberg JE, Flaig TW, Friedlander TW, et al. Study EV-103: Preliminary durability results of enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma. J Clin Oncol. 2020;38(suppl; abstr 441).
- Hoimes C, Rosenberg J, Srinivas S, et al. EV-103: Initial results of enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma. Ann Oncol. 2019;30(suppl_5):v356-v402. doi: 10.1093/annonc/mdz249.
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