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. Author manuscript; available in PMC: 2021 Jul 21.
Published in final edited form as: Expert Rev Anticancer Ther. 2020 Jul 21;20(7):551–561. doi: 10.1080/14737140.2020.1782201

Table 2.

Clinical data supporting accelerated regulatory approval of enfortumab vedotin in advanced urothelial cancer

Trial Design Setting Number of Patients ORR Median Duration of Response Median Progression-Free Survival Median Overall Survival
EV-101 Single-Arm Phase I Platinum-and Checkpoint Blockade- Refractory 112 45% (11% CR, 34% PR) 7.5 months 6.6 months (estimated) 12.3 months (estimated)
EV-201 (Cohort 1) Single-Arm Phase II Platinum- and Checkpoint Blockade- Refractory 125 44% (12% CR, 32% PR) 7.6 months 5.8 months (estimated) 11.7 months (estimated)