CSPC Pharma (CSPC Pharmaceutical Group Limited) announced that its investigational antibody-drug conjugate (ADC) SYS6010 met the pre-specified primary endpoint of progression-free survival (PFS) in the Phase III SYNSTAR-01 study for patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on prior EGFR tyrosine kinase inhibitor (TKI) therapy.

The Independent Data Monitoring Committee confirmed a statistically significant and clinically meaningful PFS improvement for SYS6010 monotherapy versus platinum-based chemotherapy. An interim analysis also indicated a favorable trend in overall survival. Safety findings were described as favorable relative to existing treatment regimens.

SYS6010 combines a humanised anti-EGFR monoclonal antibody with a topoisomerase I inhibitor payload via a cleavable linker. After binding to EGFR on tumor cells, the conjugate is internalised and releases its cytotoxic payload intracellularly to exert anti-tumor effects.

Market context underscores the commercial relevance: lung cancer remains the leading malignancy in Mainland China, with an estimated 1.18 million new cases in 2024. NSCLC constitutes about 85 % of these cases, and EGFR mutations occur in roughly 40-50 % of NSCLC patients. Current first-line EGFR TKIs face inevitable resistance, leaving limited options upon progression; SYS6010 seeks to address this therapeutic gap.

The multicenter, open-label Phase III SYNSTAR-01 trial directly compared SYS6010 with platinum-based chemotherapy, using Independent Review Committee-assessed PFS as its primary endpoint. Positive interim results position SYS6010 as a potential new treatment avenue, pending regulatory review and approval.