Pembrolizumab Shot on Par with IV

Merck announced today that pembrolizumab (Keytruda) injected subcutaneously is not inferior to intravenous (IV) dosing, currently the drug’s only approved route of administration. In the phase III MK-3475A-D77 trial, researchers found that patients with metastatic non–small cell lung cancer who received pembrolizumab plus chemotherapy had similar blood plasma concentrations of the PD-1 inhibitor regardless of how it was given. Detailed results will be presented at an upcoming medical meeting and shared with regulatory authorities. Merck’s patent on IV pembrolizumab, which generated $25 billion in sales in 2023, will expire in 2028, but the subcutaneous form of the drug would extend its patent protection.