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A phase 3 trial shows a promising new drug beats standard chemo in relapsed osteosarcoma. Risvutatug rezetecan (Ris-Rez) cut the risk of disease progression or death by 67% compared to gemcitabine plus docetaxel in patients who had already failed at least two prior therapies. The results, presented at the 2026 ESMO Congress, could pave the way for regulatory approval in China.
A new antibody-drug conjugate is showing strong results in the bone cancer space. The phase 3 ARTEMIS-011 trial showed that risvutatug rezetecan (Ris-Rez) significantly outperformed the standard chemotherapy combo of gemcitabine plus docetaxel in patients with relapsed or refractory osteosarcoma who had already gone through at least two prior lines of treatment. The trial enrolled 122 patients — many of them young adults and adolescents — across 24 sites in China.
Ris-Rez works by targeting B7-H3, a protein found on cancer cells, and delivering a cell-killing payload directly to the tumor. The drug had already earned FDA breakthrough therapy designation in early 2025 based on earlier phase 2 data, and these phase 3 results reinforce its potential as a meaningful treatment advance.
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Why it matters: Osteosarcoma is the most common bone cancer in children and young adults, and options after initial treatment failure are extremely limited. Ris-Rez's dramatic PFS improvement in this heavily pretreated population represents a potentially practice-changing development, with data intended to support a regulatory submission in China.
