Hansoh Pharmaceutical has recorded another late-stage success for its B7-H3-targeting antibody-drug conjugate (ADC), developed in partnership with GSK, after the therapy met the primary endpoint in a Phase 3 trial involving patients with relapsed osteosarcoma in China.
The latest result follows the companies’ recent Phase 3 victory in small-cell lung cancer (SCLC). In the new study, risvutatug rezetecan (ris-rez) was compared with chemotherapy in patients whose osteosarcoma had relapsed or progressed after receiving at least two previous lines of systemic treatment.
How the Therapy Performed
According to GSK, the investigational therapy significantly extended progression-free survival compared with chemotherapy. The company also reported favorable outcomes across secondary measures, including overall survival, while noting that no new safety concerns emerged during the study.
Speaking during the company’s second-quarter earnings briefing, GSK Chief Executive Officer Luke Miels said achieving positive results in a treatment that could benefit children with cancer represented an especially meaningful milestone.
Although detailed efficacy data have not yet been released, Hansoh considers the findings sufficiently strong to begin preparing a regulatory submission in China. The encouraging outcome also strengthens expectations for GSK’s ongoing global Embold Sarcoma-202 Phase 1b/2 study, which is evaluating ris-rez in patients with previously managed unresectable advanced or metastatic sarcomas, including osteosarcoma.
More About Osteosarcoma
Osteosarcoma is a rare bone cancer that primarily affects children and young adults, with a worldwide incidence of approximately 3.4 cases per million people each year. While chemotherapy remains the standard first-line treatment, therapeutic options become increasingly limited after relapse, particularly for patients whose disease has progressed following two or more prior treatment regimens.
Last month, GSK launched the global Embold Sarcoma-202 trial, which is enrolling patients with both osteosarcoma and soft tissue sarcoma. The study forms part of the company’s broader strategy to expand ris-rez beyond its initial focus on second-line SCLC, where a separate phase 3 trial began in 2025.
Future Plans For Ris-Rez
Earlier this year, GSK Chief Scientific Officer Tony Wood outlined plans to broaden the development program for ris-rez through several additional Phase 3 studies, including trials in genitourinary cancers that are scheduled to begin later this year.
This development strategy closely aligns with the priorities of Merck & Co. and Daiichi Sankyo for their competing B7-H3-targeted ADC, ifinatamab deruxtecan (I-DXd). Their program recently reached an important regulatory milestone after the FDA accepted the therapy for review as a second-line treatment for SCLC. The partners are also conducting Phase 3 studies in esophageal squamous cell carcinoma and prostate cancer.
Although GSK entered the B7-H3 ADC race later than some competitors, the company has consistently identified ris-rez and another related antibody-drug conjugate as key strategic assets within its oncology pipeline.
GSK Senior Vice President and Global Head of Oncology Research & Development Hesham Abdullah said the latest results, together with the recently reported pivotal findings in small-cell lung cancer, reinforce confidence in the broad potential of ris-rez and further support B7-H3 as a promising therapeutic target across multiple types of cancer, which is great news for the company.
Hansoh has announced positive Phase 3 clinical trial results for its priority antibody-drug conjugate (ADC), marking another important milestone in the company’s oncology development program. The successful study strengthens Hansoh’s position in the rapidly expanding ADC market and supports the continued development of innovative targeted cancer therapies designed to improve patient outcomes.
Why the Hansoh Phase 3 Results Matter
The latest Phase 3 success demonstrates Hansoh’s commitment to advancing next-generation oncology treatments. Positive late-stage clinical data increase confidence in the therapy’s potential effectiveness and safety while supporting future regulatory submissions in key global markets.
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