KEYTRUDA is an anti-PD-1 therapy developed by Merck. Credit: Copyright © 2023 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved. Keytruda 100mg/4mL Vial and Carton 2015

Merck has secured approval from the US Food and Drug Administration (FDA) for KEYTRUDA (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv) for first-line treatment of some adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC).

KEYTRUDA is an anti-PD-1 therapy developed by Merck, while Padcev has been developed by Astellas and Seagen.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The combination therapy can be used to treat la/mUC patients who do not qualify for cisplatin-containing chemotherapy.

Merck stated that the regulatory approval represents the first of its kind received by an anti-PD-1 therapy in combination with an antibody-drug conjugate for use in targeted patients in the US.

It is supported by objective response rates (ORR) and median duration of response (DOR) in combined dose escalation/cohort A and cohort K of the Phase lb/ll KEYNOTE-869 study, also known as the EV-103 trial.

See Also:

The trial was jointly conducted by Seagen and Astellas.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Results showed that patients treated with Padcev along with KEYTRUDA achieved a confirmed ORR of 68%. 12% experienced a complete response and 55% a partial response.

Merck Research Laboratories senior vice-president, global clinical development head and chief medical officer Dr Eliav Barr said: “This approval is a major milestone in the treatment of patients with locally advanced or metastatic urothelial carcinoma because it is the first approved combination of an immunotherapy and an antibody-drug conjugate for these patients.

“This expands the use of KEYTRUDA-based regimens to more patients with advanced urothelial carcinoma, and demonstrates the value of collaboration in creating new combination approaches for patients in need of more options.”