FDA approves Keytruda + Padcev for first-line treatment of certain patients with locally advanced or metastatic urothelial (bladder) cancer
Merck Inc., known as MSD outside of the United States and Canada, announced the FDA has approved Keytruda, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv) for the treatment of adult patients with 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. This marks the first time an anti-PD-1 therapy has been approved in combination with an antibody-drug conjugate in the U.S. in these patients.
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. The median follow-up time for the dose escalation cohort + Cohort A was 44.7 months (range, 0.7 to 52.4 months) and for Cohort K was 14.8 months (range, 0.6 to 26.2 months). 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% (95% CI: 58.7, 76.0), 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).
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