Ris-Rez Cuts Osteosarcoma Progression Risk 67% in China Phase III
GSK sits 19% above its 52-week low of $42.845.
Summary
GSK's licensor Hansoh reported positive phase III results for Ris-Rez in relapsed osteosarcoma in China, with progression risk cut 67% and median PFS of 5.5 versus 1.4 months. The data support a China filing by Hansoh and inform GSK's own global sarcoma programme.
Key Events · Product Development and Regulatory · GSK
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ARTEMIS-011 Meets Primary Endpoint
In relapsed osteosarcoma after at least two prior lines of therapy, Ris-Rez reduced the risk of disease progression or death by 67% versus chemotherapy (HR 0.33; 95% CI 0.20-0.55; p<0.0001).
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Median PFS 5.5 vs 1.4 Months
Median progression-free survival was 5.5 months on Ris-Rez versus 1.4 months on gemcitabine/docetaxel, after a median follow-up of 7.1 months.
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High-Grade Toxicity Remains a Constraint
Grade 3 or higher treatment-related adverse events occurred in 93% of patients at the 12 mg/kg Ris-Rez dose versus 83% on chemotherapy, mostly haematologic; TRAEs led to discontinuation in 4% versus 2%.
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China Filing by Hansoh; GSK Runs Global Study
The data will support a regulatory submission by Hansoh in China. Meanwhile, GSK's phase Ib/II EMBOLD Sarcoma-202 trial in advanced osteosarcoma and soft tissue sarcoma is ongoing and will use these results to inform dose selection.
Analysis · GSK · Life Sciences
The near-term revenue from ARTEMIS-011 sits with Hansoh, which ran the trial in relapsed osteosarcoma and will file in China. For GSK, the value lies in validation of the B7-H3 antibody-drug conjugate platform and in dose guidance for its own global sarcoma study. The trial met its primary endpoint with a hazard ratio of 0.33: patients on Ris-Rez stayed progression-free 5.5 months versus 1.4 months on chemotherapy. Safety is the caveat. At the 12 mg/kg dose, 93% of patients had Grade 3 or higher treatment-related events, mostly haematologic, a high bar for a paediatric and young-adult population.
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At the time of this filing, GSK was trading at $51.12 on NYSE in the Life Sciences sector, with a market capitalization of approximately $101.5B. The 52-week trading range was $42.85 to $61.70. This filing was assessed with positive market sentiment and an importance score of 7 out of 10.