MSD (MRK.US) pabolizumab injection (subcutaneous injection) declared for listing in China

The Zhitong Finance App learned that on June 7, the CDE official website showed that MSD (MRK.US)'s pabolizumab injection (subcutaneous injection, that is, MK-3475A) was declared for sale in China.

In November 2024, MSD announced that the critical phase III MK-3475A-D77 study had achieved positive results. The study assessed the pharmacokinetics (PK), efficacy, and safety of pabolizumab subcutaneous injection mk-3475a compared with pabolizumab intravenous keytruda for first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC).

MK-3475A-D77 is a randomized, open-label phase III clinical study (NCT05722015) involving a total of 378 patients. The two main endpoints of the study were the area under the drug time curve (AUC) of pabolizumab during the first administration cycle and the lowest concentration of pabolizumab administration (Ctrough) measured at steady state. Secondary endpoints include other PK parameters, efficacy indicators (including objective remission rate, duration of remission, progression-free survival, and overall survival), and safety endpoints.

The results showed that the study reached its dual primary end. Specifically, compared with Keytruda combination chemotherapy administered intravenously, the AUC exposure of pabolizumab showed no poor efficacy during the first administration cycle of MK-3475A combined chemotherapy, and the measured Pabolizumab concentration (Ctrough) in the steady state thereafter also showed no poor efficacy. Furthermore, the efficacy and safety secondary endpoints of the two groups were generally the same.