Zhitong Finance App News, Columbotai Biotech (06990) announced that the marketing application for a new indication of the company's antibody-conjugated drug (ADC) targeting human trophic cell surface antigen 2 (TROP2), lukansastuzumab (SAC-TMT, also known as SKB264/MK-2870) (Cathay Lai®) has been accepted by the China National Drug Administration (NMPA) Drug Evaluation Center (CDE).
The new indications are for first-line treatment of adult patients with epidermal growth factor receptor (EGFR) gene mutation negative and anaplastic lymphoma kinase (ALK) negative and anaplastic lymphoma kinase (ALK) negative for tumor expression of programmed cell death ligand 1 (PDL1)) in combination with the MSD monoclonal antibody (PDL1®) in first-line treatment of tumors expressing programmed cell death ligand 1 (PDL1). This application is the seventh application for marketing of lucansastuzumab (sAC-TMT) accepted by the NMPA.
This application is based on the positive results of the Phase 3 registered OptiTrop-Lung06 study, which aims to evaluate the efficacy and safety of lucansastuzumab (saC-TMT) combined with pabolizumab versus chemotherapy combined with pabolizumab first-line treatment in patients with PD-L1-negative locally advanced or metastatic non-squamous NSCLC. The study directly compared the two treatment strategies of “ADC combination immunotherapy” and “combination immunotherapy”.
In a predetermined mid-term analysis, compared with pabolizumab (Sac-TMT) combined with pabolizumab combined with pemetrexed and platinum-containing chemotherapy, showed significant improvements in the progression-free survival (PFS) of the primary endpoint assessed by blind independent center review (BICR), and benefit trends were also observed in the overall survival (OS) of secondary endpoints. The safety characteristics of this joint program are consistent with previous research reports, and no new safety signals have been observed.