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Abstract

The KEYNOTE-A18 trial is a Phase 3, randomized, non-inferiority study assessing subcutaneous (SC) pembrolizumab (MK- 3475A with hyaluronidase) versus intravenous (IV) pembrolizumab for advanced melanoma, NSCLC, RCC, HNSCC, and UC. It enrolled 1756 patients, comparing 600 mg SC Q6W with standard IV dosing. Primary endpoints include PK equivalence (Cmax, AUC) and ORR for melanoma and NSCLC. Secondary endpoints cover broader PK, ORR across all tumors, DCR, DOR, PFS, OS, safety, and PROs. Non-inferiority criteria were stringent for both PK and ORR. This study aims to validate SC pembrolizumab as an equally effective and safe alternative, enhancing patient convenience.