Merck, known as MSD outside of the US and Canada, said that the Phase 3 lung cancer trial of subcutaneous (SC) pembrolizumab with chemotherapy met its primary pharmacokinetic (PK) endpoints.
The MK-3475A-D77 trial tested the noninferiority of SC administration of pembrolizumab, Merck’s anti-PD-1 therapy, available for intravenous use as Keytruda. This was combined with berahyaluronidase alfa, a hyaluronidase variant developed and manufactured by Alteogen, administered with chemotherapy.
The combination was compared with intravenous (IV) Keytruda plus chemotherapy for treating metastatic non-small cell lung cancer (NSCLC) in adults.
The trial saw the participation of an estimated 378 patients, who were randomised in a 2:1 ratio to receive either SC pembrolizumab with chemotherapy or IV Keytruda with chemotherapy.
SC pembrolizumab, given every six weeks, demonstrated noninferiority in both Area Under the Curve (AUC) exposure during the first dosing cycle and the trough concentration (Ctrough) at steady state, when compared to IV Keytruda with chemotherapy.
Secondary efficacy and safety endpoints were generally similar for both SC pembrolizumab and IV Keytruda.
These findings, along with ongoing analyses, will be presented at a medical meeting and shared with global regulatory authorities.
Merck Research Laboratories senior vice president and global clinical development oncology head Marjorie Green said: “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.”
Merck’s SC pembrolizumab clinical development programme includes several key trials. The Phase 3 MK-3475A-F84 trial compares SC pembrolizumab alone to IV Keytruda for first-line treatment of metastatic NSCLC with high PD-L1 expression.
The Phase 2 MK-3475A-F65 trial evaluates SC pembrolizumab alone for relapsed or refractory classical Hodgkin lymphoma and relapsed or refractory primary mediastinal large B-cell lymphoma.
Additionally, the American pharmaceutical company is conducting a Phase 2 MK-3475A-F11 patient preference study. It examines participant-reported preferences between SC pembrolizumab and IV Keytruda.
Last month, the European Commission approved two new indications for Keytruda for gynaecologic cancers.
