Hansoh Pharma reports encouraging outcomes from a second Phase III investigation of Ris-Rez

Hansoh Pharmaceutical Group has confirmed that its pivotal Phase III ARTEMIS-011 investigation of risvutatug rezetecan satisfied its primary progression-free survival endpoint in osteosarcoma patients whose disease had progressed or returned following a minimum of two prior systemic treatment regimens.

Carried out exclusively in patients based in China, the investigation showed that Ris-Rez, a B7-H3-directed antibody-drug conjugate, produced gains in progression-free survival over chemotherapy that were both statistically significant and clinically meaningful. Benefits held firm when secondary measures were examined, with overall survival among the consistent positive findings. No unfamiliar safety concerns arose, with the profile matching what prior research in this tumour category had already established. Hansoh Pharma intends to draw on this dataset in support of a Chinese regulatory filing.

On the global stage, GSK is moving EMBOLD Sarcoma-202 forward, a Phase Ib/II investigation of Ris-Rez in patients with previously treated unresectable advanced or metastatic sarcomas including osteosarcoma. This sits within a far-reaching programme spanning lung and prostate cancers and additional solid malignancies, underpinned by GSK’s exclusive right to develop Ris-Rez in markets beyond mainland China, Hong Kong, Macau, and Taiwan. The FDA has previously recognised Ris-Rez with Breakthrough Therapy Designation in the relapsed or refractory osteosarcoma setting.

Coming on the heels of pivotal readouts in advanced or relapsed small-cell lung cancer, these fresh osteosarcoma results position Ris-Rez as the sole B7-H3-directed antibody-drug conjugate to have generated positive Phase III data across distinct tumour categories.

“Building on recent pivotal data in small-cell lung cancer, these results strengthen our confidence in the broad potential of Ris-Rez and validate B7-H3 as a promising target across multiple tumour types,” said Hesham Abdullah, Senior Vice President and Global Head of Oncology Research and Development, GSK.

Osteosarcoma tends to emerge in children and younger adults and holds the distinction of being the single most common cancer arising primarily in bone, representing somewhere between a fifth and two-fifths of all bone cancer diagnoses. Globally, new cases arise at a rate of roughly 3.4 per million people each year, making it a genuinely rare disease. When patients relapse after initial chemotherapy, meaningful treatment pathways become scarce, and the absence of any recognised standard of care compounds the challenge. For those who have exhausted two prior lines of treatment, the situation grows still more constrained, with no approved options currently on the table.

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Hansoh Pharma, Ris-Rez, second Phase III investigation