publication date: Oct. 20, 2016
Melanoma Yervoy Improved OS in Fully Resected Stage III Patients from Phase III Study
Distant metastasis-free survival, a secondary endpoint, was also significantly improved versus placebo (HR=0.76 [95.8% CI: 0.64-0.92; p=0.002]) and had five-year DMFS rates of 48.3% and 38.9% in the Yervoy and placebo groups, respectively.
In this updated five-year analysis, the recurrence-free survival (primary endpoint) benefit observed previously with Yervoy was maintained (HR=0.76 [95% CI: 0.64-0.89; p<0.001).
The safety profile remained consistent with the initial analysis, with no new deaths or safety signals. The most common grade 3/4 immune-related adverse events in the Yervoy group were gastrointestinal (16.1%), hepatic (10.8%), and endocrine (7.9%).
These data were featured Oct. 8, during the 2016 European Society for Medical Oncology Congress Press Program and simultaneously published in The New England Journal of Medicine.
“Despite surgical intervention, most patients with stage III melanoma experience disease recurrence and progress to metastatic disease, reinforcing the unmet need for effective systemic therapies in the adjuvant setting,” said Alexander Eggermont, director general, Cancer Institute Gustave Roussy in Villejuif, France. “The impact of Yervoy on overall survival, distant-metastasis free survival, and recurrence-free survival observed in study -029 offers physicians new insights in the treatment of adjuvant melanoma.”
In stage III melanoma, the disease has not yet spread to distant lymph nodes or to other … Continue reading CCL Oct 2016 – Yervoy Improved OS in Fully Resected Stage III Patients from Phase III Study
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