GSK's Ris-Rez Phase III SCLC Trial Meets Primary Endpoint
GSK's licensor, Hansoh Pharmaceutical Group Co., Ltd., announced positive Phase III results for risvutatug rezetecan (Ris-Rez) in China. The ARTEMIS-008 study, evaluating Ris-Rez in advanced or relapsed small-cell lung cancer (SCLC), met its primary endpoint of overall survival, showing statistically significant and clinically meaningful improvements. This represents the first positive Phase III overall survival data for a B7-H3-targeted antibody-drug conjugate in any tumor type, with Hansoh Pharma planning regulatory submission in China. GSK holds exclusive global rights for Ris-Rez development outside China and is advancing the drug across multiple tumor types, with pivotal data from its global Phase III EMBOLD SCLC-301 trial expected next year.
Key Highlights
- GSK's licensor Hansoh Pharma announced positive Phase III results for Ris-Rez in China.
- ARTEMIS-008 study met its primary endpoint of overall survival (OS) in advanced or relapsed small-cell lung cancer (SCLC).
- This marks the first positive Phase III OS data for a B7-H3-targeted ADC in any tumor type.
- Ris-Rez demonstrated statistically significant and clinically meaningful OS improvements compared to standard of care.
- Hansoh Pharma will use these data for regulatory submission in China.
- GSK holds exclusive global rights to develop Ris-Rez outside mainland China, Hong Kong, Macau, and Taiwan.
- GSK's global Phase III EMBOLD SCLC-301 trial data is expected next year.
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