FDA Approves Merck's Keytruda Combined With Seagen/Astellas's Padcev For Advanced Urothelial Cancer - Astellas Pharma (OTC:ALPMY), Merck & Co (NYSE:MRK), Astellas Pharma (OTC:ALPMF)

The FDA approved Merck & Co Inc's MRK Keytruda (pembrolizumab) in combination with Astellas Pharma Inc ALMPF & Seagen Inc's SGEN Padcev (enfortumab vedotin-ejfv) locally advanced or metastatic urothelial carcinoma (la/mUC) who are not eligible for cisplatin-containing chemotherapy.
This indication is approved under accelerated approval based on tumor response rate and durability of response.
Related: US Senators Warren, Sanders Urge 'Close Scrutiny' On Merck's Keytruda-Related Patents.
The approval is based on data from the KEYNOTE-869 trial (also known as EV-103) dose escalation cohort, Cohort A and Cohort K, which was conducted in collaboration with Seagen and Astellas.
In the combined efficacy analysis of the dose escalation cohort, Cohort A and Cohort K (n=121), Keytruda in combination with enfortumab vedotin demonstrated an objective response rate (ORR) of 68%, with complete and partial response rates of 12% and 55%, respectively.
The median duration of response (DOR) for the dose escalation cohort + Cohort A was 22.1 months (range, 1.0+ to 46.3+ months), and for Cohort K was not reached (range, 1.2 to 24.1+ months).
The ongoing Phase 3 EV-302/KEYNOTE-A39 trial evaluating Keytruda in combination with enfortumab vedotin in untreated advanced urothelial cancer is intended to serve as the U.S. confirmatory trial for accelerated approval.
It will also serve as the basis for global registration.
Price Action: SGEN shares closed at $202.00 and MRK at $108.87 on Monday.

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