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/
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Phase II ALPACA Trial Shows Lepodisiran Produces Significant, Sustained Lipoprotein(a) Reductions
March 31st 2025Eli Lilly’s lepodisiran, an investigational siRNA therapy, achieved significant and durable reductions in lipoprotein(a) levels, a major genetic risk factor for cardiovascular disease.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
FOCUS Trial Results Show Solriamfetol Significantly Reduces ADHD Symptoms, Severity in Adults
March 27th 2025Solriamfetol achieved the primary and key secondary endpoint of the Phase III FOCUS trial by significantly lowering attention-deficit hyperactivity disorder symptoms and disease severity in adults compared to placebo, with a favorable safety and tolerability profile.
