11:48 AM EDT, 03/27/2025 (MT Newswires) -- Merck ( MRK ) said Thursday that a phase 3 trial evaluating subcutaneous pembrolizumab together with berahyaluronidase alfa met the study's primary endpoints, as pembrolizumab administered with chemotherapy demonstrated noninferior pharmacokinetics compared with intravenous Keytruda combined with chemotherapy.

Subcutaneous pembrolizumab also showed consistent results for objective response rate, progression-free survival, duration of response and safety, according to the company.

The company said the US Food and Drug Administration has accepted a biologics license application to review subcutaneous pembrolizumab across all previously approved solid tumor indications for Keytruda and set a target action date of Sept. 23.

The European Medicines Agency also validated an extension application for the new pharmaceutical form and new route of administration of Keytruda, Merck ( MRK ) said.

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