GSK announced Friday that its licensed cancer therapy, risvutatug rezetecan (Ris-Rez), met its primary endpoint of overall survival. The pivotal Phase 3 trial treated patients with advanced or relapsed small-cell lung cancer.
Partner Hansoh Pharmaceutical Group conducted the study in China. Ris-Rez demonstrated a statistically significant improvement in overall survival compared to the standard treatment, topotecan.
These results represent the first positive Phase 3 overall survival data for a B7-H3-targeted antibody-drug conjugate (ADC) in any tumor type. GSK holds exclusive global rights to develop and commercialize the drug outside of greater China.
The company expects data from its own global Phase 3 trial in a similar patient population next year. GSK shares rose modestly in London trading following the announcement.