CSPC announced that SYS6010 met the pre-specified primary endpoint in phase 3 trial

CAR-T Digest - August 2020

26 August 2026: CSPC announced that SYS6010 met the pre-specified primary endpoint in phase 3 trial

CSPC Pharmaceutical Group announced that its EGFR-targeted ADC SYS6010 met the pre-specified primary endpoint of PFS in the phase 3 study, demonstrating a statistically significant and clinically meaningful improvement versus platinum-based chemotherapy in EGFR-mutated locally advanced or metastatic NSCLC following EGFR-TKI failure
The randomized phase 3 SYNSTAR-01 trial evaluated SYS6010 monotherapy versus platinum-based chemotherapy, with PFS assessed by an Independent Review Committee as the primary endpoint; the pre-specified interim analysis also showed a trend toward overall survival benefit, with a favorable overall safety profile
The results address a significant unmet need in EGFR-mutated advanced NSCLC, where patients commonly develop resistance following EGFR-TKI treatment and have limited effective options in the post-TKI setting
SYS6010 is an EGFR-targeted ADC comprising a humanized anti-EGFR monoclonal antibody conjugated to a topoisomerase I inhibitor payload through a cleavable linker, enabling EGFR-mediated internalization and intracellular release of the cytotoxic payload
Strategically, the positive Phase 3 results strengthen SYS6010’s potential as a post-EGFR-TKI treatment option, support its future commercialization prospects in a large EGFR-mutated NSCLC population, and further expand CSPC’s presence in the competitive EGFR-targeted ADC landscape