Astellas and Seagen Report Updated Results of Padcev in Two Studies for Locally Advanced or Metastatic Urothelial Cancer Not Eligible for Cisplatin Chemotherapy

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The companies reported the positive results from two studies (EV-201 and EV-103) evaluating Padcev as monothx. and in combination with Merck’s Keytruda in patients with LA or mUC who are not able to receive cisplatin CT respectively
An updated analysis of EV-201 Cohort 2 showed that 51% achieved confirmed objective response with CR (22%), mDOR (13.8mos.), mPFS (6.7mos.); OS (16.1mos.) with a median follow up of 16mos. The FDA has granted PR to the supplemental application of Padcev based on these results
EV-103 cohort A patients demonstrated a safety profile is consistent with previous findings, with no new safety signals observed. The data will be presented at ASCO2021

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