Merck’s Injectable Keytruda Shows Promising Results in Pivotal Trial

Merck's subcutaneous formulation of Keytruda demonstrated non-inferiority to the intravenous version in a pivotal Phase 3 trial7.

The study, named 3475A-D77, involved patients with metastatic non-small cell lung cancer7.

Subcutaneous Keytruda achieved slightly higher overall response rate (45.4% vs 42.1%) and progression-free survival (8.1 months vs 7.8 months) compared to IV formulation when combined with chemotherapy7.

The new formulation reduced patient chair time by 49.7% and healthcare professional active time by 45.7%3.

Median injection time for subcutaneous Keytruda was approximately 2-3 minutes, compared to the 30-minute IV infusion13.

The FDA has set a PDUFA date of September 23, 2025, for the Biologics License Application review of subcutaneous Keytruda3.

Adverse effects occurred at similar rates (47%) for both formulations7.

Merck developed the injectable version using Alteogen's hyaluronidase technology17.

This new formulation is part of Merck's strategy to extend Keytruda's patent life beyond its expected expiration in 20287.

The European Medicines Agency has also validated an extension application for this new administration route3.

Sources:

1. https://medcitynews.com/2024/11/merck-keytruda-subcutaneous-injection-cancer-pembrolizumab-biosimilar-alteogen-mrk/

3. https://www.stocktitan.net/news/MRK/merck-s-investigational-subcutaneous-pembrolizumab-with-0e9bg061bwfc.html

7. https://www.biospace.com/drug-development/mercks-injectable-keytruda-matches-iv-formula-in-pivotal-trial