GSK announced Friday that its licensed cancer therapy, risvutatug rezetecan (Ris-Rez), met its primary endpoint of overall survival in a pivotal Phase 3 trial. The study evaluated patients with advanced or relapsed small-cell lung cancer. Partner Hansoh Pharmaceutical Group conducted the clinical trial in China.
Ris-Rez demonstrated a statistically significant improvement in overall survival compared to the current standard of care, topotecan. These results mark the first positive Phase 3 overall survival data for a B7-H3-targeted antibody-drug conjugate 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 saw a modest increase in London trading following the news.