Nexavar Plus Paclitaxel Show Progression Free Survival By 74%

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals have announced results from a randomised, 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. The results 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.

The randomised, 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 randomised to receive 400mg of oral Nexavar or matching placebo twice daily, in addition to paclitaxel, given at 90mg/m2 weekly for three weeks followed by one week of rest.

The results demonstrated 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.

Todd Yancey, vice president of clinical development at Onyx, said: “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. 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.”