GSK’s bet on Hansoh Pharmaceutical’s antibody-drug conjugate (ADC) seems to be paying off as the drug met all its endpoints in a Phase III trial in China.
In the pivotal ARTEMIS-008 trial (NCT06498479), risvutatug rezetecan (Ris-Rez) met its primary endpoint of overall survival (OS) in patients with advanced or relapsed small-cell lung cancer (SCLC).
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In the trial, conducted in patients in China, Ris-Rez demonstrated statistically significant and clinically meaningful improvements in OS compared with topotecan, a standard of care (SoC) chemotherapy drug.
Consistent benefit was also observed across key secondary endpoints, including progression-free survival (PFS).
GSK said that these are the first positive Phase III overall survival data reported for a B7-H3-targeted ADC in any tumour type. The safety profile is consistent with prior Ris-Rez findings, and no new safety signals were identified.
Ris-Rez targets the B7-H3 protein, which is highly expressed in SCLC tumours. GSK said that 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 extensive stage (ES)-SCLC. Patients with ES-SCLC have a poor two-year survival rate of about 7%.
Hesham Abdullah, senior VP and global head of oncology, R&D, at GSK, said: “These results are an important milestone as the first positive Phase III OS 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 the standard of care in areas of high unmet need.”
The data will be used by Hansoh Pharma for regulatory submission in China.
GSK signed an exclusive licence agreement worth up to $1.71bn with Hansoh Pharma for joint rights to the ADC in December 2023. The deal granted GSK the rights to develop and commercialise the ADC worldwide, excluding mainland China, Taiwan, Hong Kong and Macau. 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 (NCT07099898) in relapsed ES-SCLC with pivotal data expected in 2027.
Ris-Rez has been granted 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. It has also gained 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 FDA.
The SCLC landscape has seen some recent late-stage advances following a drought in development. This includes a Phase III success for Daiichi Sankyo’s ADC ifinatamab deruxtecan (I-Dxd), which triggered an objective response rate (ORR) of 48.2% in pre-treated ES-SCLC patients.
The drug was granted priority review by the FDA and has a Prescription Drug User Fee Act (PDUFA) date of 10 October 2026.
Meanwhile, Amgen gained accelerated approval in May 2024 for its immunotherapy drug Imdelltra (tarlatamab) for adult ES-SCLC patients who have experienced disease progression on or after platinum-based chemotherapy. The drug later received full FDA approval in November 2025 based on the results of the Phase III DeLLphi-304 study.
Imdelltra is the first delta-like ligand 3 (DLL3)-targeting bispecific T-cell engager (BiTE) molecule designed to activate the patient’s own T cells to target and attack DLL3-expressing tumour cells.
