Onyx Pharmaceuticals Inc (ONXX)

[surf1944]

Results Reported for Exploratory Phase 2 Study of Nexavar in Combination With Chemotherapeutic Agent Paclitaxel for Treatment of Advanced Breast Cancer
Preliminary Results Require Further Analysis and Interpretation
Press Release
Source: Onyx Pharmaceuticals, Inc.; Bayer HealthCare Pharmaceuticals Inc.
On Wednesday September 30, 2009, 2:00 am EDT

Companies:Onyx Pharmaceuticals Inc.
WAYNE, N.J. and EMERYVILLE, Calif., Sept. 30 /PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX - News) today announced results from a randomized, placebo-controlled Phase 2 trial sponsored by Northwestern University. The study, which evaluated Nexavar® (sorafenib) tablets in combination with the chemotherapeutic agent, paclitaxel, in patients with locally advanced or metastatic HER-2 negative breast cancer, demonstrated a positive trend towards improvement of progression-free survival in the treatment group (p-value=0.09). The safety and tolerability profile of the combination was consistent with the previous experience with each agent and no new toxicities were observed.

A complete data analysis from this study is expected to be presented at an upcoming scientific meeting. Patients are continuing to be followed for a secondary endpoint of overall survival.

The trial was led by principle investigator William Gradishar, M.D., professor of medicine, Robert H. Lurie Comprehensive Cancer Center of Northwestern University. "These encouraging data warrant further investigation to determine the potential of the Nexavar and paclitaxel treatment combination in patients with advanced breast cancer, an often underserved patient population," said Dr. Gradishar.

"The preliminary results in this study demonstrate a clinical signal in favor of this treatment combination. These data require further analysis and interpretation before we determine the appropriate path forward," said Todd Yancey, M.D., vice president of clinical development at Onyx. "This trial is the second of four from our comprehensive clinical program in breast cancer, which is intended to explore Nexavar's utility in a number of disease settings."

Bayer and Onyx recently reported statistically significant results in a randomized Phase 2 trial demonstrating that Nexavar in combination with the oral chemotherapeutic agent, capecitabine, significantly extended progression free survival by 74% in patients with locally advanced or metastatic HER-2 negative breast cancer. Treatment with Nexavar plus capecitabine was tolerable and resulted in no new side effects. Common grade 3 or 4 treatment-related adverse events included hand-foot skin reaction, diarrhea, dyspnea, neutropenia and mucositis.

Breast Cancer Trial Design

The randomized, double-blind, placebo-controlled Phase 2 study evaluated Nexavar in combination with the chemotherapeutic agent, paclitaxel, in 237 patients. These patients had locally recurrent or metastatic HER-2 negative breast cancer and had not received prior chemotherapy in this setting. The study included an assessment of the primary endpoint of progression-free survival. Secondary endpoints included overall survival, time to progression, and safety. Patients were randomized to receive 400 mg of oral Nexavar or matching placebo twice daily, in addition to paclitaxel, given at 90 mg/m2 weekly for three weeks followed by one week of rest.