Merck's Phase 3 Trial of Subcutaneous Keytruda Meets Primary Endpoints, Comparable to IV Version Before 2028 Patent Expiration

Nov 19, 2024, 12:24 PM

Merck announced that its Phase 3 trial for a subcutaneous formulation of Keytruda (pembrolizumab) met its primary endpoints. The study demonstrated that the injectable version is comparable to the currently approved intravenous formulation, potentially enhancing accessibility and ease of administration for patients. This development comes as Merck aims to maintain its market share for Keytruda, especially as the drug's U.S. patent is set to expire in 2028. The new formulation could provide a competitive edge against Roche's recently FDA-approved subcutaneous PD-L1-targeting drug. The trial results indicate that the subcutaneous version delivers similar blood levels of the drug as the intravenous version, which may lead to broader adoption in clinical settings.