Hansoh Pharma announces ARTEMIS-008 trial achieved primary OS endpoint in SCLC

CAR-T Digest - August 2020

10 July 2026: Hansoh Pharma announces ARTEMIS-008 trial achieved primary OS endpoint in SCLC

Hansoh Pharma announced that its B7-H3-targeted antibody-drug conjugate Risvutatug rezetecan met the primary endpoint of overall survival in the pivotal phase 3 ARTEMIS-008 trial in patients with advanced or relapsed Small cell lung cancer following prior platinum-based therapy, marking the first phase 3 study to demonstrate an OS benefit for a B7-H3-directed ADC in any tumor type
This phase 3 trial demonstrated statistically significant and clinically meaningful improvements in overall survival versus topotecan, with consistent benefit also observed for progression-free survival. The safety profile remained consistent with previous studies, with no new safety signals identified
These findings address a major unmet need in relapsed SCLC, where most patients rapidly relapse after platinum-based chemotherapy and effective second-line treatment options remain limited, positioning Risvutatug rezetecan as a potential new therapeutic option for this aggressive malignancy

Risvutatug rezetecan is a B7-H3-directed ADC comprising a fully human anti-B7-H3 monoclonal antibody linked via tetrapeptide-based cleavable linkers to multiple topoisomerase I inhibitor payloads, enabling targeted intracellular delivery of cytotoxic therapy while reducing systemic toxicity
Strategically, the positive phase 3 outcome supports Hansoh Pharma’s planned regulatory discussions with China’s NMPA for a future biologics license application, strengthens the global development of Risvutatug rezetecan through its partnership with GSK, and reinforces the growing clinical potential of B7-H3-targeted ADCs across multiple solid tumors

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