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Merck Seeks FDA Approval for Subcutaneous Pembrolizumab

Merck’s subcutaneous pembrolizumab with berylluronidase alfa shows noninferior pharmacokinetics to intravenous KEYTRUDA in pivotal trial.

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By: Charlie Sternberg

Associate Editor

Merck has shared data from the pivotal 3475A-D77 Phase 3 trial evaluating the subcutaneous administration of pembrolizumab together with berahyaluronidase alfa (subcutaneous pembrolizumab). The study met its primary endpoints, demonstrating non-inferior pharmacokinetics (PK) for subcutaneous pembrolizumab administered with chemotherapy with a median injection time of two minutes, versus intravenous (IV) Keytruda (pembrolizumab) administered with chemotherapy for the first-line treatment of ad...

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