December 31, 2024，Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) has received marketing authorization in China from National Medical Products Administration (NMPA) for the programmed cell death ligand1(PD-L1)-directed innovative humanized monoclonal antibody (“mAb”) tagitanlimab (formerly KL-A167) (科泰莱®) for the treatment of patients with recurrent or metastatic nasopharyngeal cancer (NPC) who have failed after prior 2L+ chemotherapy. This is the world’s first PD-L1 monoclonal antibody approved for the treatment of NPC.
The approval is based on a single-arm, multi-center, phase II clinical study in patients with recurrent or metastatic NPC who have failed after prior 2L+ systematic therapies, led by Professor Shi Yuankai of the Cancer Hospital Chinese Academy of Medical Sciences as the principal investigator, to evaluate the efficacy and safety profile of tagitanlimab monotherapy.
Between Feb 26th, 2019 and Jan 13th, 2021, 153 patients were treated. Totally, 132 patients entered full analysis set (FAS) and were evaluated for the efficacy. As of data cutoff date on Jul 13th, 2021, the median follow-up time was 21.7 months (95%CI 19.8–22.5). For FAS population, the IRC-assessed ORR was 26.5% (95%CI 19.2–34.9%), and disease control rate (DCR) was 56.8% (95%CI 47.9–65.4%). Median progression-free survival (PFS) was 2.8 months (95%CI 1.5–4.1) . Median duration of response was 12.4 months (95%CI 6.8–16.5), and median overall survival (OS) was 16.2 months (95%CI 13.4–21.3).
About NPC
The 2022 GLOBOCAN data showed that there were more than 120,000 new cases of nasopharyngeal cancer globally, 51,000 new cases of nasopharyngeal cancer and 28,400 deaths in China . According to the 2021 CSCO guidelines, the 1L treatment regimen for non-locally treatable recurrent or metastatic nasopharyngeal cancer is based on platinum-containing combination chemotherapy, and the 2L treatment is based on monotherapy. The 5-year survival rate of patients with recurrent or metastatic nasopharyngeal cancer is 18.5%, with a median OS of 22.1 months, and there is still an unmet clinical need to improve the clinical benefit of this group of patients, especially those who develop metastases after treatment. In recent years, immunotherapy has provided more therapeutic options for tumor patients and has become an effective way to treat patients with nasopharyngeal carcinoma.
About Tagitanlima
Tagitanlima，manufactured by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (Chengdu, China), is a fully humanized IgG1κ monoclonal antibody targeting PD-L1 that selectively blocks the interaction of PD-L1 and PD-1.
At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department.
Phone Number：4008803716
Email：myimmnet@163.com
References
1.Technology & Product Pipeline – Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
2.国家药监局批准塔戈利单抗注射液上市 (nmpa.gov.cn)
4.Chen YP, Chan ATC, Le QT, Blanchard P, Sun Y, Ma J. Nasopharyngeal carcinoma. Lancet (London, England) 2019;394(10192):64–80. doi: 10.1016/S0140-6736(19)30956-0.
Post time: Jan-07-2025