> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Subcutaneous Keytruda is Noninferior to IV Formulation: Merck
- URL: https://www.fdaweb.com/subcutaneous-keytruda-is-noninferior-to-iv-formulation-merck/
- Published: 2024-11-19T12:00:00.000Z
- Updated: 2026-09-14T14:47:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158219

Merck is reporting “positive topline results” from the pivotal Phase 3 MK-3475A-D77 trial that evaluated the noninferiority of subcutaneous administration of Keytruda (pembrolizumab) and berahyaluronidase alfa, a hyaluronidase variant manufactured by Alteogen administered with chemotherapy versus intravenous (IV) Keytruda administered with chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer.

“The Phase 3 trial met its dual primary pharmacokinetic (PK) endpoints,” Merck says. “Specifically, subcutaneous pembrolizumab administered every six weeks with chemotherapy demonstrated noninferiority of area under the curve (AUC) exposure of pembrolizumab during the first dosing cycle, and trough concentration (Ctrough) of pembrolizumab measured at steady state, compared to IV Keytruda administered every six weeks in combination with chemotherapy.”

Additionally, the company says secondary endpoints were generally consistent for subcutaneous pembrolizumab compared with the IV formulation. “These results, as well as those from ongoing analyses, will be presented at an upcoming medical meeting and shared with regulatory authorities worldwide,” Merck says.