At the JP Morgan Healthcare Conference in San Francisco on 14 January 2025, Merck (known as MSD outside the US and Canada) announced that it is expecting to “file, have approval, and launch [its] subcutaneous pembrolizumab in 2025”.
The announcement follows positive topline results obtained in November 2024 from MSD’s Phase 3 trial evaluating SC pembrolizumab (MK-3475A), together with Alteogen’s berahyaluronidase alfa, administered with chemotherapy. The SC pembrolizumab demonstrated noninferior pharmacokinetics compared to intravenous (IV) Keytruda® (pembrolizumab) in combination with chemotherapy, in adults with metastatic non-small cell lung cancer (NSCLC).
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. During 2024, MSD also obtained several Keytruda® approvals in advanced cancers, including cervical cancer (US (January 2024), EU (October 2024)), endometrial carcinoma (US (June 2024), EU (October 2024)) and malignant pleural mesothelioma (US (September 2024)).