Ris-Rez meets Phase III OS endpoint in small-cell lung cancer
- Sponsor
- GSK $GSK
- Drug
- risvutatug rezetecan
- Indication
- Advanced/relapsed small-cell lung cancer (Phase III readout); relapsed/refractory ES-SCLC + relapsed/refractory osteosarcoma (FDA Breakthrough)
GSK's licensor Hansoh Pharma reported positive Phase III ARTEMIS-008 topline: risvutatug rezetecan (Ris-Rez) improved overall survival vs topotecan in advanced/relapsed SCLC (China patient population). Ris-Rez, a B7-H3-targeted ADC licensed to GSK ex-Greater-China, holds two FDA Breakthrough Therapy Designations (r/r ES-SCLC + r/r osteosarcoma) and an EMA PRIME designation for r/r ES-SCLC.
What this means
Ris-Rez is an experimental cancer drug that couples an antibody to a chemotherapy payload — the antibody finds cancer cells that carry a protein called B7-H3 and delivers the payload inside. In a large China trial (ARTEMIS-008), patients with small-cell lung cancer whose disease had come back or advanced lived longer on Ris-Rez than on topotecan, the standard chemotherapy for this setting. Hansoh Pharma led the study and plans to submit for approval in China; GSK holds the rights outside of Greater China and will use these data to advance US and other filings. The FDA has already given Ris-Rez two Breakthrough Therapy Designations (for small-cell lung cancer and osteosarcoma) and the EMA has given it PRIME status for lung cancer — regulatory tools that signal the agencies see high unmet need and want to speed the review.
From the source
10 July 2026 | Issued: London, UK
GSK plc (LSE/NYSE: GSK) licensor Hansoh Pharmaceutical Group Co., Ltd. today announced 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.
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.
Ris-Rez holds Breakthrough Therapy Designations for relapsed or refractory ES-SCLC and relapsed or refractory osteosarcoma from the US FDA, and Priority Medicines (PRIME) Designation from the EMA for relapsed or refractory ES-SCLC.
Hesham Abdullah, Senior Vice President, 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."
Reproduced from GSK Press Releases · view original · public domain or open-licensed government work