Subcutaneous Keytruda Meets Primary Goals in Phase 3 NSCLC Trial

Key Insights

• Merck's subcutaneous Keytruda, combined with chemotherapy, demonstrated non-inferiority to intravenous Keytruda plus chemotherapy in treating metastatic non-small cell lung cancer (NSCLC).
• The Phase 3 study utilized Alteogen's berahyaluronidase alfa to enhance subcutaneous Keytruda permeation, showing positive results in first-line treatment.
• This new formulation of Keytruda offers a potential alternative administration route for patients with various cancers, including melanoma and Hodgkin lymphoma.

Merck & Co Inc. (MRK) announced that its Phase 3 study evaluating subcutaneous Keytruda, in conjunction with Alteogen Inc.'s berahyaluronidase alfa, has met its primary goals in adult patients with non-small cell lung cancer (NSCLC).

The study demonstrated that subcutaneous Keytruda plus berahyaluronidase alfa, an enzyme facilitating enhanced permeation, combined with chemotherapy, is non-inferior to intravenous (IV) Keytruda with chemotherapy for the first-line treatment of patients with metastatic NSCLC. This offers a potentially less invasive administration route for patients.

Keytruda, Merck's immunotherapy drug, is currently indicated for various cancer types, including melanoma, lung cancer, head and neck cancer, and Hodgkin lymphoma. The subcutaneous formulation could broaden its applicability and improve patient convenience.