CSPC PHARMA (01093) has announced that its investigational drug SYS6010 successfully met the predefined primary endpoint of progression-free survival (PFS) in the Phase III clinical study SYNSTAR-01. This trial evaluates the product as a monotherapy compared with platinum-based chemotherapy in patients with EGFR-mutant locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed prior EGFR tyrosine kinase inhibitor (TKI) therapy. The positive outcome was confirmed following a review by an independent data monitoring committee (IDMC).

Study results demonstrate that SYS6010 provides a statistically significant and clinically meaningful improvement in PFS over the current standard of care, while maintaining a favorable overall safety profile. The product is an antibody-drug conjugate (ADC) developed by the company, comprising a humanized anti-EGFR monoclonal antibody linked to a topoisomerase I inhibitor payload via a cleavable linker. It exerts its antitumor activity by specifically binding to EGFR receptors on tumor cell surfaces, followed by internalization and intracellular release of the cytotoxic payload.

Lung cancer ranks first in both incidence and mortality among all malignancies in mainland China, with approximately 1.176 million new cases projected for 2024. NSCLC accounts for about 85% of lung cancer cases, and EGFR mutations are present in roughly 40–50% of these patients. Currently, EGFR TKIs serve as the first-line standard treatment for advanced NSCLC patients with EGFR mutations. However, resistance to these agents inevitably develops over time, and subsequent treatment options offer limited efficacy. If successfully approved, SYS6010 could provide a novel therapeutic alternative for these patients, carrying substantial clinical value and commercial potential.

SYNSTAR-01 is a randomized, open-label, multicenter Phase III study designed to assess the efficacy and safety of SYS6010 compared with platinum-based chemotherapy in participants with EGFR-mutant locally advanced or metastatic NSCLC who have progressed on EGFR TKI therapy. The primary endpoint is PFS as evaluated by an independent review committee (IRC). With the trial now achieving its predefined primary endpoint, interim analysis data confirm that SYS6010 offers a statistically significant and clinically relevant PFS benefit over platinum-based chemotherapy, alongside a favorable trend in overall survival (OS).