publication date: Aug. 30, 2014


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Phase III Nexavar Trial Fails Primary Endpoint


A phase III trial of Nexavar tablets in patients with advanced breast cancer did not meet its primary endpoint of extending progression-free survival.

The study, called RESILIENCE, evaluated Nexavar (sorafenib) in combination with capecitabine compared to capecitabine plus placebo in patients with HER2-negative breast cancer who are resistant to or have failed prior taxane therapy, and resistant to or failed anthracycline or for whom further anthracycline therapy is not indicated.

Based on initial review of the data, the types of adverse events observed were generally comparable with those known for either sorafenib or capecitabine. Data from this study are expected to be presented at an upcoming scientific congress, according to the drug’s sponsors, Bayer HealthCare and Onyx Pharmaceuticals Inc.

RESILIENCE was a randomized, double-blind study that enrolled 537 patients in more than 20 countries.

Secondary endpoints of the trial included overall survival, time to progression, overall response rate, disease control rate, duration of response, patient reported quality of life and safety.

Patients were randomized to receive either 600 mg of oral sorafenib or matching placebo daily on a continuous schedule, in addition to 1,000 mg/m(2) of capecitabine twice daily for 14 days of a 21 day cycle.

Nexavar is approved in the U.S. for the treatment of patients with unresectable hepatocellular carcinoma, patients with advanced renal cell carcinoma and patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment.

It is thought to inhibit both the tumor cell and tumor vasculature. In in vitro studies, Nexavar has been shown to inhibit multiple kinases … Continue reading CCL August – Breast Cancer

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