US-based Merck, Sharp & Dohme Inc., (MSD, NYSE: MRK) has released positive topline results from the pivotal Phase III MK-3475A-D77 trial. The study aimed to assess the noninferiority of subcutaneous administration of PD-1 inhibitor Keytruda (pembrolizumab) combined with berahyaluronidase alfa, a hyaluronidase variant developed by Alteogen Inc., in comparison to intravenous (IV) Keytruda, both administered with chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC).
Achievement of Dual Primary Pharmacokinetic Endpoints
The study successfully met its dual primary pharmacokinetic (PK) endpoints. Subcutaneous pembrolizumab, administered every six weeks with chemotherapy, demonstrated noninferiority in terms 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.
Consistency in Efficacy and Safety
Secondary endpoints evaluating efficacy and safety were generally consistent between subcutaneous pembrolizumab administered with chemotherapy and IV Keytruda administered with chemotherapy, indicating that the subcutaneous formulation does not compromise the treatment’s effectiveness or safety profile.
Ongoing Clinical Development Program for Subcutaneous Pembrolizumab
Merck’s clinical development program for subcutaneous pembrolizumab includes additional trials such as the Phase III MK-3475A-F84 trial, which evaluates subcutaneous pembrolizumab administered alone compared to IV Keytruda alone for the first-line treatment of patients with metastatic NSCLC with high PD-L1 expression (tumor proportion score [TPS] ≥50%). The Phase II MK-3475A-F65 trial assesses subcutaneous pembrolizumab in relapsed or refractory classical Hodgkin lymphoma and relapsed or refractory primary mediastinal large B-cell lymphoma. Furthermore, Merck is conducting a Phase II patient preference study, MK-3475A-F11, to evaluate participant-reported preference for subcutaneous pembrolizumab over IV Keytruda.-Fineline Info & Tech
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