The National Medical Products Administration (NMPA) official website indicated on September 28 that Merck's pembrolizumab injection (subcutaneous injection, namely MK-3475A) has been approved for launch in China.

This formulation can be administered once every 3 weeks (completed within 1 minute) or once every 6 weeks (completed within 2 minutes), which saves time and offers greater convenience compared to the intravenous formulation that requires a 30-minute infusion, and it also allows for injection in the thigh or abdomen, avoiding the area within 5 centimeters around the navel.

In November 2024, Merck announced positive results from the pivotal Phase III MK-3475A-D77 study.

This study was a randomized, open-label clinical trial (n=378) that evaluated the pharmacokinetics (PK), efficacy, and safety of subcutaneous pembrolizumab MK-3475A compared with intravenous pembrolizumab Keytruda, in combination with chemotherapy for first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC).

The dual primary endpoints of the study were: the area under the concentration-time curve (AUC) of pembrolizumab during the first dosing cycle and the minimum concentration (Ctrough) of pembrolizumab measured at steady state.

Secondary endpoints included other PK parameters, efficacy measures (including objective response rate, duration of response, progression-free survival, and overall survival), and safety endpoints.

The results showed that the study met its dual primary endpoints.