Merck's Subcutaneous Keytruda Matches IV Version in Phase 3, Aiming to Compete with Roche and Bristol Myers

Merck has successfully completed a Phase 3 trial for the subcutaneous version of its blockbuster cancer drug, Keytruda, demonstrating non-inferiority to the currently available intravenous formulation. This subcutaneous version is poised to offer significant benefits in terms of patient convenience and accessibility, as it can be administered in 2-3 minutes compared to the 30 minutes required for the traditional IV infusion[1][2]. The trial, which included patients with metastatic non-small cell lung cancer, achieved its primary endpoint by showing that the subcutaneous version maintained similar blood levels and safety profiles as the IV form, which is crucial for regulatory approval discussions[2]. As Merck strives to maintain its competitive edge against rivals like Roche and Bristol Myers Squibb, the successful trial outcome is a strategic move to extend Keytruda's market presence before the U.S. patent expires in 2028[1].
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Explore Further
How does the subcutaneous version of Keytruda impact the overall treatment experience for patients compared to the intravenous format?
What strategies does Merck have in place to maintain Keytruda's market share against competitors like Roche and Bristol Myers Squibb after the patent expires in 2028?
What regulatory challenges might Merck face in getting global approval for subcutaneous Keytruda, and how soon could it potentially be available to patients?
How might the introduction of a subcutaneous form of Keytruda affect the competition within the oncology market, particularly in terms of pricing and availability?
What role do biosimilars from companies like Sandoz and Amgen play in the future market dynamics for Keytruda and similar cancer therapies?