At WCLC 2026, GSK and partner Hansoh Pharma reported positive interim Phase III results from ARTEMIS-008 in China.
Risvutatug rezetecan (Ris-Rez), a B7-H3-targeted antibody-drug conjugate, reduced the risk of death by 54% versus topotecan in patients with relapsed small-cell lung cancer after platinum-based therapy. The hazard ratio was 0.46 (95% CI 0.35–0.62; p<0.0001).
Median overall survival was 18.5 months with Ris-Rez versus 10.3 months with topotecan—an 8.2-month difference.
Progression-free survival was also improved:
7.2 versus 3.0 months. Response rates were 58.3% versus 12.6%.
The 461-patient China study met its primary overall-survival endpoint. The findings are described as the first positive Phase III overall-survival result for a B7-H3 ADC in any cancer type.
GSK said the safety profile was consistent with earlier data, with no new safety signals reported. Hansoh plans to use the results for a regulatory submission in China.
The result is important but geographically limited:
it was conducted in China, and regulatory approval and confirmation in broader populations remain pending.
Sources:
Ris-Rez reduced risk of death by 54% versus topotecan in ...
risvutatug rezetecan (GSK5764227) / Jiangsu Hansoh Pharma, GSK
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