On January 20th,The National Medical Products Administration (NMPA) approves the innovative humanized monoclonal antibody tagitanlimab (formerly KL-A167) Combination therapy of cisplatin and gemcitabine for first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) patients.
This is the second indication approved for Tagolizumab.Previously, NMPA has approved the marketing in China of tagitanlimab monotherapy for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy.
The approval is based on a randomized, double-blinded, placebo controlled, multi-center, phase III clinical study evaluates the efficacy and safety results of tagitanlimab in combination with cisplatin and gemcitabine versus placebo in combination with cisplatin and gemcitabine for the treatment of recurrent or metastatic NPC, which was led by Professor Shi Yuankai of the Cancer Hospital Chinese Academy of Medical Sciences as the principal investigator.
According to the study results, tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment for recurrent or metastatic NPC could have better progression-free survival (PFS), higher objective response rate (ORR) and extended duration of response (DoR) compared with chemotherapy, where all the patients could benefit regardless of the PD-L1 expression. The median PFS for tagitanlimab in combination with chemotherapy is not reached compared to 7.9 months for placebo in combination with chemotherapy, and the risk of disease progression and death is reduced by 53%; ORR is 81.7% vs 74.5%; median DoR is 11.7 vs 5.8 months, which has nearly doubled compared to placebo arm; currently the median overall survival (OS) is still not mature, however the beneficial trend for OS of tagitanlimab in combination with chemotherapy has already been observed, and its risk of death is reduced by 38%. Tagitanlimab also showed a manageable safety profile.
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
2.Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Post time: Jan-23-2025