Phase III Trial Data Show Subcutaneous Pembrolizumab as Noninferior to IV Keytruda
Subcutaneous administration of pembrolizumab with chemotherapy demonstrated a nearly 50% reduction in patient chair and treatment room time while maintaining efficacy and safety endpoints compared to intravenous Keytruda.
Merck has shared data from the 3475A-D77 Phase III clinical trial of the subcutaneous administration of pembrolizumab with berahyaluronidase alfa (MK-3475A; also referred to as “subcutaneous pembrolizumab”). An analysis of the data show meaningful reductions in patient chair and treatment room time while maintaining safety and efficacy compared to intravenous (IV) Keytruda.1
The trial met its primary endpoints, with subcutaneous pembrolizumab plus chemotherapy demonstrating noninferior pharmacokinetics with a median injection time of two minutes versus IV Keytruda plus chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC). The key secondary endpoints of objective response rate, progression-free survival, duration of response, and safety remained consistent compared to IV Keytruda.
In a press release, Enriqueta Felip, MD, PhD, head of Thoracic Tumors Group, Vall d’Hebron Institute of Oncology said: “These study findings demonstrate subcutaneous pembrolizumab reduces time demands for both the patient and the healthcare provider, all while providing a consistent efficacy and safety profile with IV pembrolizumab. As a physician, I am thrilled to see these data for subcutaneous pembrolizumab, which, if approved, have the potential to give patients valuable time back in their treatment day with results that are consistent with IV pembrolizumab.”
Subcutaneous pembrolizumab showed positive outcomes in quality of life for patients and efficiency for healthcare professionals (HCPs). Patients receiving subcutaneous pembrolizumab spent 47.4% less time in the treatment room compared to those receiving IV Keytruda. HCPs experienced a 45.7% reduction in total active time administering subcutaneous pembrolizumab versus IV Keytruda.
With these positive findings, the FDA has accepted a Biologics License Application (BLA) for the approval of subcutaneous pembrolizumab across all previously approved solid tumor indications for Keytruda. A Prescription Drug User Fee Act (PDUFA) date is set for Sept. 23, 2025.
In the press release, Marjorie Green, MD, senior vice president and head of oncology, global clinical development, Merck Research Laboratories added: “Keytruda has helped transform the treatment of certain cancers, and we continue to pursue innovations that build on this breakthrough medicine to give patients and those who treat them better experiences. If approved, we are excited about the potential of subcutaneous pembrolizumab to become a new meaningful treatment option that may increase access and save time needed for administration compared to IV Keytruda. We look forward to working with global regulatory authorities to bring the first subcutaneous checkpoint inhibitor that can be administered in approximately two minutes to patients and providers.”
Merck is also evaluating subcutaneous pembrolizumab for a number of other indications. The Phase III 3475A-F84 trial is evaluating it alone versus IV Keytruda alone for the first-line treatment of patients with metastatic NSCLC. In the Phase II 3475A-F65 study, subcutaneous pembrolizumab administered alone is being evaluated in patients with relapsed or refractory classical Hodgkin lymphoma and relapsed or refractory primary mediastinal large B-cell lymphoma. Additionally, Merck is evaluating patient preference for subcutaneous pembrolizumab versus IV Keytruda.
Reference
1. Merck’s Investigational Subcutaneous Pembrolizumab With Berahyaluronidase Alfa Demonstrates Noninferior Pharmacokinetics Compared to Intravenous (IV) KEYTRUDA® (pembrolizumab) in Pivotal 3475A-D77 Trial. News release. Merck. March 27, 2025. Accessed March 31, 2025. https://www.merck.com/news/mercks-investigational-subcutaneous-pembrolizumab-with-berahyaluronidase-alfa-demonstrates-noninferior-pharmacokinetics-compared-to-intravenous-iv-keytruda-pembrolizumab-in-pivotal/
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