Pfizer Submits First Subcutaneous PD-1 Inhibitor PF-06801591 for Clinical Trial in China

Text | Baihuawen

On May 28, the Center for Drug Evaluation (CDE) accepted Pfizer’s clinical trial application for PF-06801591 injection, marking the first subcutaneously administered PD-1 monoclonal antibody to enter clinical development in China.

Phase I clinical study (NCT02573259) results demonstrated that PF-06801591 administered subcutaneously every 4 weeks exhibited antitumor activity across multiple tumor types compared with intravenous administration every 3 weeks, and was well tolerated, with no severe cutaneous toxicities observed. Monthly subcutaneous administration of PF-06801591 may improve patient compliance and holds promise as an alternative to intravenous infusion.

Currently, Alphamab Oncology’s subcutaneous PD-L1 inhibitor KN035 has entered Phase III clinical trials. Additionally, Chase Sun Pharmaceutical’s oral PD-L1 inhibitor emadefenib tablets have entered Phase I clinical trials in China.

Pfizer/Merck’s PD-L1 inhibitor Bavencio was approved by the FDA on March 23, 2017. It has currently received approval for three indications: Merkel cell carcinoma, urothelial carcinoma, and renal cell carcinoma. Clinical trials of Bavencio are underway in China.