Results from Phase 2 trial evaluating Nexavar with capecitabine and paclitaxel presented

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced results from two collaborative group-sponsored randomized, double-blind, placebo-controlled Phase 2 trials were presented at the 32nd Annual San Antonio Breast Cancer Symposium (SABCS). The first of these studies evaluated Nexavar® (sorafenib) tablets in combination with chemotherapy agent capecitabine and the second study evaluated Nexavar in combination with paclitaxel.

"Onyx and Bayer are encouraged by these results as they suggest Nexavar may have potential as a combination therapy for advanced breast cancer patients in both the first and second-line setting," said Todd Yancey, M.D., senior vice president of clinical development at Onyx. "These findings, in particular the statistically significant results demonstrated with Nexavar in combination with capecitabine, are the basis for a registrational Phase 3 program that is expected to begin next year."

Nexavar in Combination with Capecitabine

The randomized, double-blind, placebo-controlled Phase 2 study evaluated Nexavar in combination with the oral chemotherapeutic agent, capecitabine, in 229 patients. These patients had locally advanced or metastatic HER-2 negative breast cancer and had received no more than one prior chemotherapy in this setting.

Patients receiving capecitabine plus Nexavar had a 74 percent improvement in progression-free survival as compared to those who received chemotherapy alone. The increase in median progression-free survival of capecitabine plus Nexavar versus capecitabine plus placebo was statistically significant (median 6.4 months vs. 4.1 months,>

In a post-hoc, subgroup analysis of first-line patients, the combination of capecitabine plus Nexavar significantly extended progression-free survival to 7.6 months compared to 4.1 months>

The primary endpoint of the study was 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 1000 mg/m2 of capecitabine.

Overall, treatment with capecitabine plus Nexavar did not result in any new side effects.

Common grade 3 treatment-related adverse events included hand-foot skin reaction (45%), diarrhea (5%), dyspnea (5%), neutropenia (4%) and mucositis (1%).

Top-line results from this study were previously presented at the joint 15th European CanCer Organisation (ECCO) and 34th European Society for Medical Oncology (ESMO) Multidisciplinary Congress.

Nexavar in Combination with Paclitaxel

The randomized, double-blind, placebo-controlled Phase 2 study evaluated Nexavar in combination with the chemotherapeutic agent, paclitaxel, in 237 patients. 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. These patients had locally recurrent or metastatic HER-2 negative breast cancer and had not received prior chemotherapy in this setting.

The primary endpoint of the study was progression-free survival (PFS). The PFS in patients receiving paclitaxel plus Nexavar compared to patients receiving paclitaxel plus placebo was 6.9 months vs. 5.6 months>

Secondary endpoints included overall survival, time-to-progression, and safety. The difference in time-to-progression of paclitaxel plus Nexavar versus paclitaxel plus placebo was statistically significant, 8.1 months vs. 5.6 months>

There were no new toxicities observed with the combination and adverse events were clinically manageable. Common grade 3 treatment-related adverse events included hand-foot skin reaction (30%), asthenia (7%), neutropenia (10%) and anemia (10%).

"The results from these two trials fuel our interest in exploring Nexavar in multiple settings through our comprehensive clinical program," said Dimitris Voliotis, vice president, Global Clinical Development Oncology, Bayer HealthCare. "Breast cancer is the second leading cause of cancer-related death in women, and we are committed to evaluating Nexavar's role in this often underserved patient population."