SKB BIO-B(06990) core product TROP2 ADC sacituzumab govitecan (SAC-TMT) combined with immunotherapy pembrolizumab as first-line treatment for locally advanced or metastatic non-small cell lung cancer with PD-L1 positivity granted breakthrough therapy designation by NMPA.

SKB BIO-B (06990) announced that the antibody drug conjugate (ADC) Luricanezumab monotherapy (sac-TMT, also known as SKB264/MK-2870) (Jiatailai) targeting the cell surface antigen 2 (TROP2) in combination with Merck's anti-programmed cell death protein 1 (PD-1) monoclonal antibody Pembrolizumab (Keytruda) has been granted breakthrough therapy designation by the NMPA Drug Evaluation Center for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) 1%, negative epidermal growth factor receptor (EGFR) gene mutations, and anaplastic lymphoma kinase (ALK) negativity. Breakthrough therapy designation is mainly granted for treatments for which there are currently no effective means, and the drug can provide effective prevention or treatment options or possess significant clinical advantages compared to existing treatment methods. For drugs included in the breakthrough therapy drug program, under certain conditions, conditional approval applications and priority review approval applications can be submitted when applying for drug marketing approval. Previously, the company announced the results of the phase 3 OptiTROP-Lung05 clinical trial of Luricanezumab monotherapy (sac-TMT) combined with Pembrolizumab as first-line treatment for PD-L1 positive NSCLC, showing statistically and clinically significant improvements in the primary endpoint of progression-free survival (PFS) and a trend towards benefit in overall survival (OS). The OptiTROP-Lung05 study is the first phase 3 clinical study of an immune combination ADC to reach its primary endpoint in first-line NSCLC treatment. The breakthrough therapy designation for first-line treatment of PD-L1 positive NSCLC will accelerate the evaluation and marketing process of Luricanezumab monotherapy (sac-TMT) for this indication.