- Earlier today, Seagen Inc FBI and Astellas Pharma Inc ALPMF announced topline results from the phase 1b/2 EV-103 trial (KEYNOTE-869) cohort K of Padcev (enfortumab vedotin-ejfv) in metastatic urothelial carcinoma (mUC).
- Needham says that the results from Cohort K primarily live up to expectations.
- The management has previously indicated that results from Cohort K could be used to support accelerated approval in the 1L cis-ineligible mUC setting.
- See the Seagen Analyst Page here.
- "We believe these data would meet the bar for such an expanded label," Needham added.
- SVB Leerink thinks that the lack of inclusion of the monotherapy data suggests the activity/duration is likely meaningfully less than combination, which is essential to some investors.
- "We think it is widely anticipated that the results could form the basis for an Accelerated Approval in 1L, cis ineligible bladder cancer patients in the US, representing $21 in our valuation model ($7 in EU) with overall US/EU peak sales of $7.7 billion," SVB writes.
- Price Action: SGEN shares are up 2.15% at $176.54 during the market session on the last check Tuesday.
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