Merck (NYSE: MRK), known as MSD outside the U.S. and Canada, today announced positive topline results from the pivotal Phase 3 MK-3475A-D77 trial, which assessed the noninferiority of subcutaneous pembrolizumab, Merck’s anti-PD-1 therapy, combined with chemotherapy, versus intravenous (IV) KEYTRUDA with chemotherapy for first-line treatment of metastatic non-small cell lung cancer (NSCLC) in adults.
The trial successfully met its dual primary pharmacokinetic (PK) endpoints. Subcutaneous pembrolizumab administered every six weeks with chemotherapy showed noninferiority in both the Area Under the Curve (AUC) of pembrolizumab exposure during the first dosing cycle and the trough concentration (Ctrough) of pembrolizumab at steady state, compared to IV KEYTRUDA with chemotherapy. Secondary efficacy and safety endpoints were consistent between the two groups. These findings, along with ongoing analyses, will be presented at a medical meeting and shared with regulatory authorities worldwide.
“KEYTRUDA has transformed the treatment of some of the most deadly cancers, and we continue to explore innovations that may benefit patients,” said Dr. Marjorie Green, Senior Vice President and Head of Oncology, Merck Research Laboratories. “We’re encouraged by these Phase 3 results for subcutaneous pembrolizumab, which was administered in approximately 2-3 minutes, offering potential improvements in patient experience and access compared to intravenous administration. We look forward to discussing these results with regulatory authorities globally.”
Merck’s subcutaneous pembrolizumab program also includes the Phase 3 MK-3475A-F84 trial, comparing subcutaneous pembrolizumab with IV KEYTRUDA alone in metastatic NSCLC patients with high PD-L1 expression, and the Phase 2 MK-3475A-F65 trial, evaluating subcutaneous pembrolizumab in relapsed or refractory Hodgkin lymphoma and primary mediastinal large B-cell lymphoma. Additionally, Merck is conducting a Phase 2 study (MK-3475A-F11) to evaluate patient preferences between subcutaneous and IV KEYTRUDA.
