GSK plc shared an announcement from its licensor, HansohPharmaceutical Group Co., Ltd., confirming that the pivotal phase III ARTEMIS-008 trial evaluating risvutatug rezetecan(Ris-Rez) met its primary endpoint of overall survival (OS).
The trial, conducted within a patient population in China, evaluated Ris-Rez in individuals with advanced or relapsed small-cell lung cancer (SCLC). Ris-Rez demonstrated statistically significant and clinically meaningful improvements in OS compared to the current standard of care, topotecan. Consistent benefit was also observed across key secondary endpoints, including progression-free survival, with no new safety signals identified. Notably, these findings mark the first positive phase III overall survival data reported for a B7-H3-targeted antibody-drug conjugate (ADC) in any tumor type.
“These results are an important milestone,” said HeshamAbdullah, Senior Vice President, Global Head Oncology, R&D, GSK. “They further support the potential of B7-H3 as a promising target across lung cancer and other solid tumors.”
While Hansoh Pharma will utilize these data for regulatory submission in China, GSK holds exclusive global rights to develop and commercialize Ris-Rez outside mainland China, Hong Kong, Macau, and Taiwan. GSK is advancing its own broad development program for the asset, including the global phase III EMBOLD SCLC-301 trial, with pivotal data expected next year.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
