GSK (LSE:GSK) told investors that its Chinese licensor Hansoh Pharmaceutical Group has announced positive Phase III results for risvutatug rezetecan (Ris-Rez) in advanced or relapsed small-cell lung cancer (SCLC), delivering what the companies say is the first Phase III overall survival benefit demonstrated by any B7-H3-targeted antibody-drug conjugate (ADC) across any tumour type.
The ARTEMIS-008 trial, conducted in a Chinese patient population, met its primary endpoint of overall survival with statistically significant and clinically meaningful improvement versus topotecan, the current standard of care, and showed consistent benefit across secondary endpoints including progression-free survival.
Hansoh will use the data to support a regulatory submission in China, while GSK holds exclusive rights to develop and commercialise Ris-Rez outside mainland China, Hong Kong, Macau and Taiwan, pursuing multiple tumour types including lung cancer, prostate cancer and other solid tumours.
"These results are an important milestone," said Hesham Abdullah, GSK's Senior Vice President and Global Head of Oncology R&D, citing the data's support for B7-H3 as "a promising target across lung cancer and other solid tumours."
Ris-Rez has received Breakthrough Therapy Designations from the US FDA in relapsed or refractory SCLC and osteosarcoma, alongside PRIME designation from the European Medicines Agency in relapsed ES-SCLC.
Pivotal data from GSK's own global Phase III EMBOLD SCLC-301 trial in relapsed extensive-stage SCLC are expected next year.
