China National Medical Products Administration approves tislelizumab to treat metastatic urothelial carcinoma with PD-L1 high expression .- BeiGene Ltd

BeiGene, Ltd. announced that its anti-PD-1 antibody tislelizumab has received approval from the China National Medical Products Administration (NMPA) as a treatment for patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Following tislelizumab’s initial approval in classical Hodgkin’s lymphoma (cHL) by the NMPA in December 2019, this is the second indication approved for tislelizumab, and the first in a solid tumor indication. The supplemental new drug application (sNDA) was previously granted priority review by the Center for Drug Evaluation (CDE) of the NMPA. The NMPA approval is based on the clinical results from a single-arm, multi-center pivotal Phase II trial of tislelizumab in patients in China and South Korea with PD-L1+ locally advanced or metastatic UC who were previously treated with platinum-containing chemotherapy (NCT04004221). Among patients who were evaluable for response, with a minimum follow-up of 12 months and a median follow-up of 14 months, the objective response rate (ORR) as assessed by the independent review committee (IRC) per RECIST v1.1 criteria was 24.8%, and the complete response (CR) rate was 9.9%. The safety data for tislelizumab included in the label is based on 934 patients treated with tislelizumab monotherapy from four clinical trials, including the aforementioned pivotal Phase II trial in patients with UC. Most common ( greater than 10%) adverse reactions included rash, fatigue, and increased alanine aminotransferase. Grade 3 or higher adverse reactions occurring in greater than 1% of patients included: increased gamma?glutamyl transferase, anemia, increased aspartate aminotransferase, increased alanine aminotransferase, pneumonitis, severe skin reactions, and hypokalemia.