MSD has reported positive topline outcomes from the Phase III MK-3475A-D77 study assessing the noninferiority of subcutaneous Keytruda (pembrolizumab) administration, in conjunction with chemotherapy, for the first-line treatment of individuals with metastatic non-small cell lung cancer (NSCLC).
Pembrolizumab is available for intravenous use as Keytruda.
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The open-label trial enrolled approximately 378 subjects randomised in a 2:1 ratio to receive either pembrolizumab’s subcutaneous form with chemotherapy or intravenous (IV) Keytruda and chemotherapy, administered every six weeks.
The findings demonstrated that pembrolizumab, administered alongside Alteogen’s berahyaluronidase alfa, achieved a non-inferior area under the curve (AUC) exposure and trough concentration (Ctrough) of pembrolizumab at a steady state, versus IV Keytruda.
The trial met its dual primary pharmacokinetic endpoints.
Secondary endpoints related to efficacy and safety were observed to be steady between the subcutaneous and IV forms of pembrolizumab, when administered alongside chemotherapy.
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By GlobalDataThe MK-3475A-D77 trial is part of a broader clinical development programme for pembrolizumab. This includes the Phase III MK-3475A-F84 study comparing subcutaneous pembrolizumab alone to IV Keytruda alone in metastatic NSCLC patients with high PD-L1 expression.
In addition, the Phase II MK-3475A-F65 trial is evaluating the subcutaneous form in relapsed or refractory classical Hodgkin lymphoma and primary mediastinal large B-cell lymphoma.
MSD is also conducting the Phase II MK-3475A-F11 patient preference trial to evaluate patient-reported preference for subcutaneous pembrolizumab compared to its IV counterpart.
MSD Research Laboratories oncology, global clinical development head and senior vice-president Dr 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 III results evaluating this fixed-dose combination of subcutaneous pembrolizumab, which was administered, on average, in approximately two to three 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.”
Last month, Moderna and MSD initiated a Phase III study to evaluate mRNA-4157 (V940) in combination with Keytruda to treat NSCLC.
