The Zhitong Finance App learned that on September 28, the official website of the National Drug Administration (NMPA) showed that MSD's pabolizumab injection (subcutaneous injection, or MK-3475A) was approved for marketing in China. The preparation can be injected once every 3 weeks (complete administration within 1 minute) or once every 6 weeks (complete administration within 2 minutes). It is more time-saving and convenient than intravenous preparations that require 30 minutes of intravenous infusion to complete administration, and can also be injected into the thigh or abdomen to avoid the 5 cm area around the navel.
In November 2024, MSD announced that the critical phase III MK-3475A-D77 study had achieved positive results. The study was a randomized, open-label clinical trial (n=378) to evaluate the pharmacokinetics (PK), efficacy, and safety of the 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). 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.