GSK licensor Hansoh Pharma reports positive Phase III outcomes for Ris-Rez in Chinese patient population

GSK licensor Hansoh Pharmaceutical Group has announced that ARTEMIS-008, its pivotal Phase III trial of risvutatug rezetecan in patients with advanced or relapsed small-cell lung cancer, has met its primary endpoint of overall survival. Conducted entirely within a Chinese patient population, the trial showed Ris-Rez delivering statistically significant and clinically meaningful gains in overall survival against topotecan, the current standard of care. Consistent benefit was also recorded across key secondary endpoints including progression-free survival. Hansoh Pharma intends to use the data to support a regulatory submission in China.

The results mark a landmark moment, representing the first time a B7-H3-targeted antibody-drug conjugate has produced positive Phase III overall survival data in any tumour type. The safety profile remained in keeping with prior Ris-Rez data, with no new concerns identified.

GSK holds exclusive rights to develop Ris-Rez globally outside mainland China, Hong Kong, Macau, and Taiwan. Its broad development programme spans 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, with pivotal data anticipated next year.

“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,” said Hesham Abdullah, Senior Vice President and Global Head of Oncology Research and Development, GSK.

Extensive-stage small-cell lung cancer carries a particularly difficult outlook for patients, with the majority relapsing following initial treatment, leaving them with scarce options, a poor prognosis, and a considerable treatment burden. B7-H3 is expressed at high levels in small-cell lung cancer tumours, and the positive ARTEMIS-008 results add meaningfully to the accumulating body of evidence pointing to encouraging clinical activity and a manageable safety profile for Ris-Rez in this patient group.

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GSK, GSK licensor Hansoh Pharma, phase III, Ris-Rez