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
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
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.
The trial was jointly conducted by Seagen and Astellas.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataResults 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.”
