RE: Therapy4 May 2026 09:49
Strangely Viking they didn't just chuck this out, trials have been ongoing for a while:
The clinical development of the subcutaneous formulation of Keytruda (Keytruda QL) progressed through several trial phases starting in 2021:
Trial Start Dates
Phase 1 (Bioavailability Study): The initial study evaluating the subcutaneous delivery of pembrolizumab (NCT05017012) officially began on 21 September 2021.
Phase 3 (Pivotal Trial): The MK-3475A-D77 study (NCT05722015), which supported the final FDA approval, began on 14 February 2023.
ClinicalTrials.gov
+3
Trial Timeline Overview
February 2023: Phase 3 trial initiation for first-line treatment of metastatic non-small cell lung cancer (NSCLC).
July 2024: Primary completion of the Phase 3 trial, providing the key data on pharmacokinetics and safety.
November 2024: Merck announced that the Phase 3 trial met its primary endpoints.
September 2025: Official FDA approval for adult and paediatric solid tumor