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Bayer And Onyx Pharmaceuticals Report Phase 3 Trial Results Of NEXAVAR® (sorafenib) In Patients With Advanced Breast Cancer

WHIPPANY, N.J. and SOUTH SAN FRANCISCO, Calif., July 25, 2014 /PRNewswire/ -- Bayer HealthCare and Onyx Pharmaceuticals Inc., an Amgen subsidiary (NASDAQ: AMGN), today announced that an investigational Phase 3 trial of NEXAVAR ® (sorafenib) tablets in patients with advanced breast cancer did not meet its primary endpoint of improving progression-free survival (PFS).

The study, called RESILIENCE, evaluated the efficacy and safety of sorafenib in combination with capecitabine, an oral chemotherapeutic agent, compared to placebo plus capecitabine, 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.

"We are disappointed that the trial did not show an improvement in progression-free survival in patients with advanced breast cancer," said Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development.  "While the primary endpoint of this trial was not met, the trial results do not affect the currently approved indications for NEXAVAR. We would like to thank the patients and the study investigators for their contributions and participation in this study."

Phase 3 Trial Design The RESILIENCE (Phase 3 T Rial Comparing Capecitabin E in Combination with Sorafen Ib or P Lacebo for Treatment of Locally Advanced or Metastat Ic H ER2– Negative Breast Canc Er) trial was a randomized, double-blind, placebo-controlled Phase III study which enrolled 537 patients in more than 20 countries, including the United States, Europe, Japan and Australia. The study evaluated sorafenib in combination with capecitabine in patients with locally advanced or metastatic HER2-negative breast cancer who are resistant to or failed prior taxane therapy, and resistant to or failed anthracycline or for whom further anthracycline is not indicated.

The primary endpoint of the study was progression-free survival. Secondary endpoints 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.

About NEXAVAR ® (sorafenib) Tablets 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. NEXAVAR is thought to inhibit both the tumor cell and tumor vasculature. In in vitro studies, NEXAVAR has been shown to inhibit multiple kinases thought to be involved in both cell proliferation (growth) and angiogenesis (blood supply) – two important processes that enable cancer growth. These kinases include Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.

NEXAVAR is currently approved in more than 100 countries. NEXAVAR is also being evaluated by Bayer and Onyx, international study groups, government agencies and individual investigators in a range of cancers.

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