Jun 10, 2022 07:17 PM (GMT+8)
On June 10, Baiji Shenzhou announced its independently developed PD-1 monoclonal antibody baizean ® (common name: tirelizumab injection) combined with chemotherapy for the first-line treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (rm-npc) has been officially approved by the State Drug Administration (nmpa). With the approval of this new indication, bazaar ® Nine indications have been obtained in China, becoming the domestic PD-1 monoclonal antibody product with the most approved indications.
Baizean ® New indications for recurrent or metastatic NPC were approved based on the results of a multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial, rationale 309. A total of 263 patients were enrolled in the ratio 309 and randomly assigned to bezoar at a ratio of 1:1 ® Plus chemotherapy group or placebo plus chemotherapy group.
According to the analysis of the updated data of rationale 309 released by Baekje Shenzhou at the 2022 American Society of Clinical Oncology (ASCO) plenary meeting, when the median follow-up time was 15.5 months, based on the evaluation of the Independent Review Committee (IRC), baekzean ® The median PFS of patients treated with combined chemotherapy was 9.6 months (stratified risk ratio (HR) =0.50 [ci:0.37, 0.68]), and the risk of disease progression / death decreased by 50%, while the median PFS of patients treated with placebo combined chemotherapy was 7.4 months ® Combined chemotherapy still showed clinically significant PFS benefit in patients with rm-npc.
This text is a result of machine translation.