Bayer HealthCare Pharmaceuticals Inc., a German chemical and pharmaceutical company, and Onyx Pharmaceuticals Inc., a pharmaceutical research company, specializing in cancer treatments, stopped the trial of Nexavar.
Nexavar is a drug approved for the treatment of advanced renal cell carcinoma (primary kidney cancer). It has also received "Fast Track" designation by the FDA for the treatment of advanced hepatocellular carcinoma (primary liver cancer), and has since performed well in Phase III trials.
The reason for this sudden stop is that the study would not meet its primary goal of improving overall survival.
The drug was approved by the U.S. Food and Drug Administration (FDA) on December 20, 2005 and received a E.U. marketing authorisation on July 19, 2006.
A New England Journal of Medicine article published in January 2007 showed compared with placebo, treatment with Nexavar prolongs progression-free survival in patients with advanced clear-cell renal-cell carcinoma in whom previous therapy has failed; the median progression-free survival was 5.5 months in the Nexavar group and 2.8 months in the placebo group (hazard ratio for disease progression in the Nexavar group, 0.44; 95% confidence interval [CI], 0.35 to 0.55; P<0.01). The first interim analysis of overall survival in May 2005 showed that Nexavar reduced the risk of death, as compared with placebo (hazard ratio, 0.72; 95% CI, 0.54 to 0.94; P=0.02), although this benefit was not statistically significant according to the O'Brien–Fleming threshold. Partial responses were reported as the best response in 10% of patients receiving Nexavar and in 2% of those receiving placebo (P<0.001).
At ASCO 2007, results from the SHARP trial were presented, which showed efficacy of Nexavar in hepatocellular carcinoma. The primary endpoint was overall survival, which showed a 44% improvement in patients who received Nexavar compared to placebo (hazard ratio 0.69; 95% CI, 0.55 to 0.87; p=0.0001). Both median survival and time to progression showed 3-month improvements.
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