Shots:

• 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

  Ref: PRNewswire | Image: Astellas