B7-H3 ADC Risvutatug Rezetecan Beats Chemo in Small Cell Lung Cancer, First Ever for the Class

Hansoh Pharma and GSK announced that the Phase 3 ARTEMIS-008 trial met its primary endpoint, with risvutatug rezetecan (Ris-Rez), a B7-H3-targeted antibody-drug conjugate, demonstrating statistically significant and clinically meaningful overall survival improvement versus topotecan in patients with advanced or relapsed small cell lung cancer who progressed on prior platinum-based chemotherapy. GSK said this is the first positive Phase 3 overall survival result reported for any B7-H3-targeted ADC in any tumor type, in a trial population based in China. Progression-free survival data also favored the ADC, with a safety profile consistent with earlier-phase studies. Global validation is ongoing in the EMBOLD SCLC-301 trial, with a pivotal readout expected in 2027.