CSPC PHARMA (01093): The Phase III clinical study of SYS6010 for EGFR mutation-positive locally advanced or metastatic NSCLC that has failed EGFR TKI treatment has reached its pre-set primary endpoint.

CSPC PHARMA (01093) announced that its developed product SYS6010 recently achieved the predefined primary endpoint of progression-free survival (PFS) in a Phase III clinical study (SYNSTAR-01) assessing the product as a single agent compared to platinum-based chemotherapy for patients with EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs). The independent data monitoring committee (IDMC) reviewed the assessment and confirmed the successful achievement of this endpoint. Study data indicated that the PFS of this product significantly outperformed existing treatment options, with meaningful statistical significance and clinical relevance, and the overall safety profile of the product is favorable. This product is a targeted EGFR antibody-drug conjugate (ADC) developed by the group, which consists of a humanized anti-EGFR monoclonal antibody conjugated via a cleavable linker to a topoisomerase I inhibitor payload. The product specifically binds to the EGFR receptors on the surface of tumor cells and releases the cytotoxic payload intracellularly upon internalization, thereby exerting its anti-tumor pharmacological effects. Lung cancer has the highest incidence and mortality rates of malignant tumors in mainland China, with an estimated 1.176 million new cases in 2024, of which approximately 85% are NSCLC cases, with about 40-50% of these patients having EGFR mutations. Currently, EGFR TKIs are the first-line treatment for patients with EGFR mutation-positive advanced NSCLC. However, patients will inevitably develop resistance following EGFR TKI treatment, and the efficacy of subsequent treatment regimens is limited. If this product is successfully approved for market launch, it will provide new treatment options for patients and possesses significant clinical application value and commercialization prospects. SYNSTAR-01 is a randomized, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of this product compared to platinum-based chemotherapy in participants with EGFR mutation-positive locally advanced or metastatic NSCLC who have failed EGFR TKI treatment, with the primary endpoint being progression-free survival (PFS) assessed by an independent review committee (IRC). Currently, this study has successfully achieved its predefined primary endpoint and has obtained positive results. Statistical analysis data confirm that, in the predefined interim analysis, this product demonstrates a statistically significant and clinically meaningful improvement in PFS compared to platinum-based chemotherapy, with an observed trend towards benefit in overall survival (OS).