Merck’s Subcutaneous Pembrolizumab Shows Promise in Phase 3 Lung Cancer Trial

Merck has unveiled promising results from its pivotal 3475A-D77 Phase 3 trial, assessing the subcutaneous administration of pembrolizumab with berahyaluronidase alfa for treating metastatic non-small cell lung cancer (NSCLC). Presented at the European Lung Cancer Congress (ELCC) 2025, the study demonstrated noninferior pharmacokinetics compared to intravenous (IV) pembrolizumab (KEYTRUDA®), with a two-minute injection time—a potential game-changer for patient convenience. The trial also showed comparable efficacy and safety outcomes, reinforcing subcutaneous pembrolizumab’s role as a viable alternative for NSCLC treatment.

Following these findings, Merck’s Biologics License Application (BLA) for subcutaneous pembrolizumab is now under FDA review, with a target action date of September 23, 2025. Simultaneously, the European Medicines Agency (EMA) is reviewing an application to introduce this new administration route. If approved, this innovation could enhance accessibility and ease of treatment for cancer patients globally, marking another step forward in Merck’s commitment to advancing oncology care.