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- The FDA approved Merck & Co Inc's (NYSE:MRK) Keytruda (pembrolizumab) in combination with Astellas Pharma Inc (OTC:ALMPF) & Seagen Inc's (NASDAQ: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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