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TRIALS AND TRIBULATIONS

Novartis Breast Cancer Drug Fails Trial

Failure scrubs company’s hope of expanding Afinitor's use in common liver cancer.

SHERYL P. DENKER

The Burrill Report

Novartis’ breast cancer drug Afinitor failed a late-stage clinical trial for locally advanced or metastatic hepatocellular carcinoma, the most common type of liver cancer.

The study was designed to determine if patients unresponsive to other therapies would be responsive to Afinitor, but it showed the drug did not extend overall survival compared to a placebo, the trial’s primary endpoint. The 546 patients enrolled in the trial either had to be intolerant to Bayer and Onyx’s kinase inhibitor, Nexavar, or had to have cancers that progressed after previous treatment with Nexavar.

While Afinitor is a kinase inhibitor like Nexavar, it targets a distinct class of enzymes.

Afinitor is currently approved and marketed for treating hormone receptor-positive, HER2 negative advanced breast cancer in postmenopausal women after failed Nexavar treatment, advanced pancreatic neuroendocrine tumors, and advanced renal cell carcinoma.

Novartis will continue to develop Afinitor for other cancers where activation of the kinase pathways targeted by the drug appear to play a role in tumor formation and progression. Those cancers include gastrointestinal and lung neuroendocrine tumors, HER2-positive breast cancer, lymphoma, and the benign, slow-growing tumors associated with the genetic disease tuberous sclerosis complex. Results of those trials are expected in the next few years.



August 07, 2013
http://www.burrillreport.com/article-novartis_breast_cancer_drug_fails_trial_.html

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