On 19 November 2024, MSD (Merck in the US and Canada) announced positive topline results from its Phase 3 trial evaluating subcutaneous (SC) administration of pembrolizumab, together with Alteogen’s berahyaluronidase alfa, administered with chemotherapy. The SC pembrolizumab (MK-3475A) demonstrated noninferior pharmacokinetics compared to intravenous (IV) Keytruda® (pembrolizumab,) in combination with chemotherapy, in adults with metastatic non-small cell lung cancer (NSCLC).
The Phase 3 trial (MK-3475A-D77) is part of MSD’s SC pembrolizumab clinical development program, which also includes a Phase 3 trial (MK-3475A-F84), evaluating SC pembrolizumab versus IV Keytruda®, each administered alone, for first-line treatment of patients with metastatic NSCLC whose tumours have high PD-L1 expression, and a Phase 2 trial (MK-3475A-F65) evaluating SC pembrolizumab in relapsed or refractory classical Hodgkin lymphoma or primary mediastinal large B-cell lymphoma. MSD is also conducting a Phase 2 patient preference study (MK-3475A-F11) to assess reported preference for SC pembrolizumab versus IV Keytruda®.
In October 2024, MSD reported 17% growth in Keytruda® sales for Q3 2024, to US$7.4 billion, attributed to increased global uptake in earlier stage indications, including triple negative breast cancer, renal cell carcinoma and NSCLC, together with continued global demand for metastatic indications.