Shiyao Group (01093): The phase III clinical study of SYS6010 EGFR mutant locally advanced or metastatic NSCLC in which EGFR TKI treatment failed reached the intended main study end point

Zhitong Finance App News, Shiyao Group (01093) announced that SYS6010 (this product), developed by the Group recently evaluated the product as a single drug compared platinum-containing chemotherapy for use with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) in a phase III clinical study (SYNSTAR-01) on EGFR mutant locally advanced or metastatic non-small cell lung cancer (NSCLC), which was reviewed and evaluated by the Independent Data Monitoring Committee (IDMC) and successfully achieved the main presupposition of progression-free survival (PFS) I want Research end point. Research data shows that the PFS of this product is significantly superior to existing treatment plans, the differences in efficacy are statistically significant and clinically significant, and the overall safety of the product is good.

This product is an antibody conjugation drug (ADC) targeting EGFR developed by the Group. It is a humanized anti-EGFR monoclonal antibody, which is coupled to a topoisomerase I inhibitor load through a lyzable ligand. This product can specifically bind to EGFR receptors on the surface of tumor cells and release cytotoxic loads within cells after internalization, thereby exerting anti-tumor pharmacological effects. Lung cancer ranks first among malignant tumors in both incidence rate and death rate in mainland China. In 2024, there are about 1.176,000 new cases. NSCLC accounts for 85% of lung cancer cases, of which patients with EGFR mutations account for about 40-50%. Currently, EGFRTKI is the first-line standard treatment plan for NSCLC patients with advanced EGFR mutations. However, patients will inevitably develop drug resistance after receiving EGFRTKI treatment, and treatment options after drug resistance have limited efficacy. If the product is successfully approved for marketing, it will bring new treatment options to patients, and has high clinical application value and commercialization prospects.

SYNSTAR-01 is a randomized, open, multicenter phase III clinical study to evaluate the efficacy and safety of this product compared to platinum-containing chemotherapy in participants with EGFR mutant locally advanced or metastatic non-small cell lung cancer who failed EGFRTKI treatment. The main end point of the study was PFS assessed by an independent review committee (IRC).

At present, this study has successfully reached the predetermined main end point and achieved positive results. Statistical analysis data confirmed that in the pre-set mid-term analysis, compared with platinum-containing chemotherapy, the product achieved statistically significant and clinically significant improvements in PFS, and overall survival (OS) showed a trend of benefit.