Merck’s Subcutaneous Keytruda Shows Non-Inferiority in Phase 3 Trial, Paving Way for Regulatory Discussions

Phase 3 Trial Success:
Merck's subcutaneous formulation of Keytruda (pembrolizumab) has demonstrated non-inferiority to the intravenous version in a phase 3 trial for adults with metastatic non-small cell lung cancer34.

Pharmacokinetic Endpoints:
The trial met its dual primary pharmacokinetic endpoints, showing non-inferior Area Under the Curve (AUC) exposure and trough concentration (Ctrough) compared to IV Keytruda3.

Efficacy and Safety:
Secondary endpoints of efficacy and safety were generally consistent for subcutaneous pembrolizumab compared with IV Keytruda3.

Regulatory Discussions:
Merck plans to discuss these results with regulatory authorities worldwide, aiming for potential submissions for approval of the subcutaneous version35.

Patient Experience:
The subcutaneous formulation, administered in approximately 2-3 minutes, could improve the patient experience and increase access compared to intravenous administration35.

Market Context:
Keytruda is the world's top-selling medication, with $21.6 billion in revenue through the first three quarters of 2024, and faces patent expiration in 20285.

Sources:

3. https://www.merck.com/news/merck-announces-phase-3-trial-of-subcutaneous-pembrolizumab-with-berahyaluronidase-alfa-met-primary-endpoints/

4. https://www.biopharmadive.com/news/merck-subcutaneous-keytruda-phase-3-study-cancer/733341/

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