Merck's Multi-Billion Dollar Drug Keytruda's Investigational Under The Skin Injection At Par With Intravenous Formulation In Untreated Lung Cancer Patients

On Tuesday, Merck & Co Inc MRK revealed topline results from the pivotal Phase 3 MK-3475A-D77 trial evaluating the noninferiority of subcutaneous administration of pembrolizumab together with berahyaluronidase alfa, 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).

Pembrolizumab is available for intravenous use as Keytruda,

Berahyaluronidase alfa is a hyaluronidase variant developed and manufactured by Alteogen Inc.

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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.

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 for the first-line treatment of patients with metastatic NSCLC whose tumors have high PD-L1 expression, as well as the Phase 2 MK-3475A-F65 trial evaluating subcutaneous pembrolizumab administered alone in relapsed or refractory classical Hodgkin lymphoma and 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.

Price Action: MRK stock is down 0.56% at $96.03 at the last check on Tuesday.

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Photo Courtesy of Merck