Group 1 - Company Keren Biotechnology (06990) announced that its antibody-drug conjugate (ADC) sac-TMT, targeting TROP2, has received breakthrough therapy designation from the NMPA for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with PD-L1 tumor proportion score (TPS) ≥ 1% [1] - The breakthrough therapy designation is granted to drugs that provide effective treatment options for conditions with no effective therapies or demonstrate significant clinical advantages over existing treatments [1] - The designation allows for conditional approval applications and priority review during the drug registration process if certain conditions are met [1] Group 2 - The company previously reported significant improvements in progression-free survival (PFS) and observed a trend in overall survival (OS) in the Phase 3 OptiTROP-Lung05 clinical trial of sac-TMT combined with pembrolizumab for treating PD-L1 positive NSCLC [2] - The OptiTROP-Lung05 study is the first Phase 3 clinical trial to achieve its primary endpoint with an immune combination ADC in first-line treatment of NSCLC [2] - The breakthrough therapy designation will expedite the review and approval process for sac-TMT in this indication [2]
科伦博泰生物-B(06990)核心产品TROP2 ADC芦康沙妥珠单抗(SAC-TMT)联合免疫疗法帕博利珠单抗一线治疗PD-L1阳性局部晚期或转移性非小细胞肺癌获NMPA突破性疗法认定