Merck Launches First Phase III Trial of Subcutaneous Pembrolizumab Formulation (MK-3475A) in First-Line Metastatic NSCLC

On February 10, MSD registered a Phase III clinical trial (code-named MK-3475A-D77) on the ClinicalTrials.gov website. The trial aims to evaluate the pharmacokinetic properties and safety of the subcutaneous injection formulation MK-3475A of pembrolizumab compared with its intravenous formulation for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC). MK-3475A consists of pembrolizumab and hyaluronidase.

This study is a randomized, open-label, positive-controlled clinical trial expected to enroll 339 treatment-naïve NSCLC patients. The primary endpoints of the study are the area under the curve (AUC) of pembrolizumab measured after the first dose and the trough concentration of pembrolizumab measured at steady state. Information indicates that the study will commence on February 20, 2023, and conclude on September 23, 2024.

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