GSK and Hansoh Pharmaceutical announced on July 10 that their pivotal Phase 3 trial of an experimental B7-H3-targeted antibody-drug conjugate, risvutatug rezetecan (ris-rez), achieved its main goal by extending overall survival for patients with small cell lung cancer. The ARTEMIS-008 study was conducted in China and compared ris-rez to the standard of care for advanced small cell lung cancer.
According to GSK, the trial met its primary endpoint of overall survival, although specific data were not disclosed. The company said these results represent the first positive Phase 3 overall survival data for a B7-H3-targeted antibody-drug conjugate in any tumor type. The open-label study enrolled approximately 460 patients who were randomized to receive either ris-rez or chemotherapy.
In addition to improving overall survival, GSK said the drug demonstrated consistent benefit across key secondary endpoints such as progression-free survival. No new safety signals were reported, which aligns with previous safety findings for ris-rez.
Hansoh plans to use the results from this trial as the basis for a regulatory submission in China. GSK intends to continue developing ris-rez across multiple tumor types and is conducting an additional global Phase 3 study in small cell lung cancer that began last year. Results from this international trial are expected by the end of next year.
Both companies have been active in licensing agreements and partnerships within the pharmaceutical industry. In December 2023, GSK paid $185 million upfront for exclusive global rights to ris-rez outside China, Hong Kong, Macau, and Taiwan as part of a deal potentially worth up to $1.7 billion.
