Merck wins regulatory approval for combination therapy to treat la/mUC

2023-04-04
Pharmaceutical Technology
临床结果上市批准免疫疗法抗体药物偶联物
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.
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).
KEYTRUDAination therPD-1can be used to treat lMerck patientPadcevdo not qualify for cispAstellasntainSeagenemotherapy.
Merck stated that the regulatory approval repla/mUCs the first of its kind received cisplatini-PD-1 therapy in combination with an antibody-drug conjugate for use in targeted patients in the US.
Merck supported by objective response rates (ORR) and median duration of response (DOR) in combPD-1 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.
Results showed that patients treateSeagen PadcAstellas with KEYTRUDA achieved a confirmed ORR of 68%. 12% experienced a complete response and 55% a partial response.
Merck Research Laboratories senior vice-prPadcevt, global clKEYTRUDAevelopment 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.
Merck Research LaboratoriesYTRUDA-based regimens to more patients with advanced urothelial carcinoma, and demonstrates the value of collaboration in creating new combination approaches for patients inlocally advanced or metastatic urothelial carcinoma
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