Long-Term Pegylated Interferon Alfa-2b Therapy in Stage III Melanoma Demonstrated Significant and Sustained Impact on Relapse-Fre... ( EORTC 18991 Phase III Study R...)

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Long-Term Pegylated Interferon Alfa-2b Therapy in Stage III Melanoma Demonstrated Significant and Sustained Impact on Relapse-Free Survival

Date:7/11/2008

EORTC 18991 Phase III Study Results Published in The Lancet

KENILWORTH, N.J., July 11 /PRNewswire-FirstCall/ -- Today, Schering-Plough (NYSE: SGP) and the EORTC announced that long-term treatment with pegylated interferon alfa-2b in stage III melanoma patients had a significant and sustained impact on relapse-free survival (RFS), according to results of a randomized phase III trial published in The Lancet today. The study, "Adjuvant Therapy with Pegylated Interferon Alfa-2b Versus Observation in Resected Stage III Melanoma: Final Results of EORTC 18991, a Randomized Phase III Trial" led by the European Organisation for the Research and Treatment of Cancer (EORTC) and Alexander Eggermont, M.D., Ph.D, was the largest positive adjuvant trial ever conducted in patients with stage III melanoma.

"Long term pegylated interferon therapy in stage III melanoma had a significant and sustained impact on relapse-free survival," said Alexander Eggermont, M.D., Ph.D., lead investigator and head of the department of surgical oncology, Erasmus University Medical Center, Rotterdam, The Netherlands.

Among the most significant findings in the study, at 3.8 years median follow up, the risk of recurrence or death was reduced by 18 percent (hazard ratio [HR] 0.82, 95 percent confidence interval [CI] 0.71-0.96; P=0.01) in the pegylated interferon alfa-2b arm compared with observation. The four-year RFS rate was 46 percent versus 39 percent in the observation arm.

"Melanoma is considered the deadliest form of skin cancer and among the most difficult to treat," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. "The results of this study are an important step in developi
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SOURCE Schering-Plough
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Long-Term Pegylated Interferon Alfa-2b Therapy in Stage III Melanoma Demonstrated Significant and Sustained Impact on Relapse-Fre...( EORTC 18991 Phase III Study R...),Health