Positive results from Nexavar Phase 2b trial on breast cancer presented at ASCO

Jul 1 2011

Accelerated Community Oncology Research Network, Inc., (ACORN), reported positive results of a large double-blind, randomized Phase 2b trial in patients with breast cancer at the American Society of Clinical Oncology (ASCO) 47th annual meeting in Chicago, June 3-7. The study, managed by ACORN Research, evaluated a novel drug regimen for the treatment of locally advanced or metastatic breast cancer.  The regimen, Nexavar® (sorafenib) tablets in combination with either Gemcitabine (Gemzar®) or Capecitabine (Xeloda®), found statistically significant improvement in progression-free survival.  Forty investigative sites enrolled 160 patients over a three year period.

Lee S. Schwartzberg, MD, FACP, President of ACORN and Chief Medical Officer of The West Clinic in Memphis, Tennessee served as study co-chair. According to Schwartzberg, "This study was conceived as one of a suite of trials collectively evaluating the addition of Nexavar to chemotherapy in different advanced disease settings. The results demonstrate activity for this antiangiogenic agent in patients who had progressed on bevacizumab containing regimens."

The trial was one of two studies sponsored by Onyx Pharmaceuticals with clinical research and site management services provided by ACORN Research. Dr. Edward Stepanski, Chief Operating Officer of ACORN Research stated, "The success of this trial was due to the enthusiasm of the investigative sites and the close cooperation with ACORN staff."

The West Clinic was, along with Memorial Sloan Kettering Cancer Center, a high enrolling site. According to Kurt Tauer, MD, FACP, Chief of Staff and principal investigator for the study at The West Clinic, "This trial was a high priority for the clinic due to the interest in adding biological agents to standard chemotherapy, and we are pleased to see the positive results."