Merck Reports Promising Subcutaneous Pembrolizumab Data

Merck, also known as MSD outside the U.S. and Canada, has announced encouraging topline results from the Phase 3 MK-3475A-D77 trial. This study assesses the effectiveness of a subcutaneous version of pembrolizumab, known commercially as KEYTRUDA® when paired with berahyaluronidase alfa (a hyaluronidase variant developed by Alteogen Inc.) and administered with chemotherapy. The goal was to compare its performance to the standard intravenous (IV) administration of KEYTRUDA with chemotherapy in treating metastatic non-small cell lung cancer (NSCLC) in adults. 

The trial successfully met its primary pharmacokinetic (PK) objectives, demonstrating that subcutaneous pembrolizumab, given every six weeks alongside chemotherapy, achieved noninferiority in terms of Area Under the Curve (AUC) exposure during the first dosing cycle and steady-state trough concentration (Ctrough) compared to intravenous KEYTRUDA administered under the same schedule. Secondary endpoints, including safety and efficacy, were also comparable between the two delivery methods. 

Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, said in a statement, “KEYTRUDA has helped transform the way we treat some of the deadliest forms of cancer, yet we continue to pursue additional innovations that may benefit patients. It is very encouraging to see positive Phase 3 results evaluating this fixed-dose combination of subcutaneous pembrolizumab, which was administered, on average, in approximately 2-3 minutes and has the potential to improve the patient experience as well as increase access for patients and healthcare providers compared to intravenous administration. We plan to discuss these results with regulatory authorities worldwide as soon as possible.”

Results from this trial, along with further analyses, will be shared at an upcoming medical conference and submitted to global regulatory authorities. Merck’s subcutaneous pembrolizumab program includes additional studies, such as the Phase 3 MK-3475A-F84 trial, comparing subcutaneous and IV pembrolizumab in patients with metastatic NSCLC and high PD-L1 expression and the Phase 2 MK-3475A-F65 trial, investigating its use in relapsed or refractory Hodgkin lymphoma and large B-cell lymphoma. A Phase 2 patient preference study (MK-3475A-F11) is also underway, examining participant-reported preferences between the subcutaneous and IV forms of pembrolizumab.