Merck announced positive topline results from the pivotal Phase 3 MK-3475A-D77 trial. The trial is evaluating the noninferiority of subcutaneous administration of pembrolizumab, Merck’s anti-PD-1 therapy, available for intravenous use as KEYTRUDA®, together with berahyaluronidase alfa, a hyaluronidase variant developed and manufactured by Alteogen Inc. (MK-3475A; “subcutaneous pembrolizumab”), 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 (NSCLC).
The Phase 3 trial met its dual primary pharmacokinetic (PK) endpoints. 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, secondary efficacy and safety endpoints were generally consistent for subcutaneous pembrolizumab administered with chemotherapy compared with IV KEYTRUDA administered with chemotherapy. These results and those from ongoing analyses will be presented at an upcoming medical meeting and shared with regulatory authorities worldwide.
“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,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “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.”
In addition to the Phase 3 MK-3475A-D77 trial, Merck’s subcutaneous pembrolizumab clinical development program includes the Phase 3 MK-3475A-F84 trial evaluating subcutaneous pembrolizumab administered alone compared to IV KEYTRUDA alone for the first-line treatment of patients with metastatic NSCLC whose tumors have high PD-L1 expression (tumor proportion score [TPS] ≥50%), as well as the Phase 2 MK-3475A-F65 trial evaluating subcutaneous pembrolizumab administered alone in relapsed or refractory classical Hodgkin lymphoma and relapsed or refractory primary mediastinal large B-cell lymphoma. Merck is also conducting a Phase 2 patient preference study, MK-3475A-F11, evaluating participant-reported preference for subcutaneous pembrolizumab compared to IV KEYTRUDA.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!