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Nexavar Phase 2 Study

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Topic: Nexavar Phase 2 Study
Posted By: 123Donna
Subject: Nexavar Phase 2 Study
Date Posted: May 21 2011 at 11:38am

Nexavar In Combination With Chemotherapy Improves Progression-Free Survival In Patients With Advanced Breast Cancer In Phase 2 Study

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. today announced results from a Phase 2b trial evaluating - Nexavar (sorafenib) tablets in patients with locally advanced or metastatic - breast cancer previously treated with a bevacizumab-containing regimen, which showed that Nexavar was associated with statistically significant improvements in progression-free survival (the primary endpoint of the study) and time-to-progression. The study evaluated Nexavar in combination with a chemotherapeutic agents, either, gemcitabine or capecitabine. The data will be presented during an oral session at the 2011 Annual Meeting of the American Society of Clinical Oncology (ASCO), June 3-7, in Chicago, IL.

Clifford Hudis, M.D., Chief of the Breast Cancer Medicine Service and attending physician at the Memorial Sloan-Kettering Cancer Center, as well as Professor of Medicine at Weill Cornell Medical College, reported that patients receiving Nexavar in addition to standard chemotherapy agents obtained a progression-free survival benefit with median 3.4 months to progression versus 2.7 (HR=0.65, one-sided p-value=0.01). Time-toprogression was similarly improved from a median of 3.6 months from 2.7 months (HR=0.64; one-sided p-value =0.009) in this pre-treated population.

"These results demonstrate the importance of evaluating anti-angiogenic compounds and should remain a high priority for the research community," said Dr. Hudis.

"We continue to explore the utility of Nexavar as a potential treatment option for breast - cancer patients in variety of settings through our clinical trial program, such as in the ongoing RESILIENCE (Phase 3 TRial Comparing CapecitabinE in Combination with SorafenIb or PLacebo for Treatment of Locally Advanced or MetastatIc HER2-Negative Breast CancEr) trial," said Dr. Dimitris Voliotis, Vice President, Global Clinical Development Oncology, Bayer HealthCare. "As the second leading cause of cancerrelated death in women, there is still an unmet need for treatments for these advanced patients. We remain committed to evaluating Nexavar in this patient population."

To read the entire article: -

DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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