On July 10, 2026 GSK plc (LSE/NYSE: GSK) licensor Hansoh Pharmaceutical Group Co., Ltd. reported that ARTEMIS-008, its pivotal phase III trial evaluating risvutatug rezetecan (Ris-Rez) in patients with advanced or relapsed small-cell lung cancer (SCLC), met its primary endpoint of overall survival (OS). In the trial, conducted in patients in China, Ris-Rez demonstrated statistically significant and clinically meaningful improvements in OS compared with the standard of care, topotecan. Consistent benefit was also observed across key secondary endpoints, including progression-free survival. These data will be used by Hansoh Pharma for regulatory submission in China.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
These are the first positive phase III overall survival data reported for a B7-H3-targeted antibody-drug conjugate (ADC) in any tumour type. The safety profile is consistent with prior Ris-Rez findings, and no new safety signals were identified.
GSK holds exclusive global rights to develop Ris-Rez outside mainland China, Hong Kong, Macau and Taiwan. GSK’s broad clinical development programme includes studies in lung cancer, prostate cancer and other solid tumours, including the global phase III EMBOLD SCLC-301 trial in relapsed extensive-stage small-cell lung cancer (ES-SCLC) with pivotal data expected next year.
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK said: "These results are an important milestone as the first positive phase III overall survival data for a B7-H3-targeted ADC in any tumour type. Together, with other data generated to date, they further support the potential of B7-H3 as a promising target across lung cancer and other solid tumours and reinforce our continued development of Ris-Rez to improve standard of care in areas of high unmet need."
Most patients with ES-SCLC relapse after initial therapy and have limited treatment options, poor prognosis and significant treatment burden.1 B7-H3 is highly expressed in SCLC tumours2,3 and the positive results from ARTEMIS-008 add to the growing body of evidence supporting the encouraging clinical activity and manageable safety profile of Ris-Rez in patients with ES-SCLC.
About risvutatug rezetecan
Ris-Rez is a novel investigational B7-H3-targeted ADC composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor payload. GSK acquired exclusive worldwide rights (excluding China’s mainland, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to progress clinical development and commercialisation of Ris-Rez.
Regulatory designations received for Ris-Rez to date include orphan drug designations from the US Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labour and Welfare in SCLC and the European Medicines Agency (EMA) in a category of cancer that includes SCLC, called pulmonary neuroendocrine carcinoma; Priority Medicines (PRIME) Designation from the EMA for relapsed or refractory ES-SCLC; and Breakthrough Therapy Designations for relapsed or refractory ES-SCLC and relapsed or refractory osteosarcoma from the US FDA.
(Press release, GlaxoSmithKline, JUL 10, 2026, View Source [SID1234669140])