Ris-Rez Delivers Again: GSK's ADC Hits Primary Endpoint in Second Phase III Trial, Now in Osteosarcoma
GSK sits 47% above its 52-week low of $36.75.
Summary
Hansoh Pharma, GSK's licensor, announced that the phase III ARTEMIS-011 trial of Ris-Rez in relapsed osteosarcoma met its primary endpoint of progression-free survival, with a consistent benefit in overall survival and no new safety signals. The results bolster confidence in Ris-Rez's broad potential and support a regulatory filing in China.
Key Events · Product Development and Regulatory · GSK
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Phase III Osteosarcoma Trial Met Primary Endpoint
Conducted in China, ARTEMIS-011 demonstrated a statistically significant and clinically meaningful improvement in progression-free survival for Ris-Rez versus chemotherapy in relapsed osteosarcoma patients who had received at least two prior lines of therapy.
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Consistent Benefit Across Secondary Endpoints
Overall survival also favored Ris-Rez, with a safety profile consistent with prior findings and no new safety signals identified.
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Only B7-H3 ADC with Positive Phase III Data in Multiple Tumors
Following recent pivotal data in small-cell lung cancer, these results make Ris-Rez the only B7-H3-targeted ADC to deliver positive phase III outcomes across multiple tumor types.
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Regulatory Submission Planned in China
Hansoh Pharma will use the ARTEMIS-011 data for regulatory submission in China, where Ris-Rez could become the first approved therapy for late-line relapsed osteosarcoma.
Analysis · GSK · Life Sciences
Ris-Rez continues to build a compelling late-stage profile, with positive phase III data in osteosarcoma arriving on the heels of pivotal SCLC results. It now stands as the only B7-H3-targeted ADC to deliver positive phase III outcomes across multiple tumor types. Osteosarcoma, a rare bone cancer with no approved therapies beyond two prior lines, represents an area of high unmet need. GSK holds ex-China rights and is advancing a global sarcoma trial, positioning Ris-Rez as a potential blockbuster oncology asset. The data will support a regulatory submission in China by partner Hansoh, while GSK's own development program expands across lung, prostate, and other solid tumors.
At the time of this filing, GSK was trading at $54.02 on NYSE in the Life Sciences sector, with a market capitalization of approximately $104.4B. The 52-week trading range was $36.75 to $61.70. This filing was assessed with positive market sentiment and an importance score of 8 out of 10.