On August 11, Pfizer’s PF-06801591 injection was approved in China to conduct clinical trials for the treatment of high-risk non-muscle-invasive bladder cancer.
PF-06801591 is a subcutaneously administered PD-1 monoclonal antibody. Results from the Phase I clinical trial (NCT02573259) demonstrated that PF-06801591, administered via subcutaneous injection once every four weeks, exhibited antitumor activity across multiple tumor types compared with intravenous infusion once every three weeks, and was well tolerated with no severe cutaneous toxicity observed. The once-monthly subcutaneous administration of PF-06801591 can improve patient compliance and holds promise as an alternative to intravenous infusion.
Non-muscle-invasive bladder cancer (NMIBC) is the most common type of bladder cancer, with approximately 300,000 new cases diagnosed globally each year. The current mainstay treatments include transurethral resection of bladder tumor (TURBT) and intravesical bacillus Calmette-Guérin (BCG) therapy; however, most patients experience recurrence. For patients who do not respond to BCG therapy, the conventional treatment has been radical cystectomy, but this procedure significantly impacts patients’ long-term quality of life and imposes considerable psychological stress.
FDA Approves New Indication for Merck’s Keytruda on January 8 for Monotherapy in Patients with BCG-Unresponsive, High-Risk NMIBC with Carcinoma In Situ, With or Without Papillary Tumors, Who Are Unable or Unwilling to Undergo Cystectomy
Currently, Alphamab Oncology’s subcutaneous PD-L1 inhibitor KN035 has entered Phase III clinical trials. Additionally, Chase Sun Pharmaceutical’s oral PD-L1 inhibitor emadifenib tablets have entered Phase I clinical trials in China.