Results from Phase 2 trial evaluating Nexavar with capecitabine and paclitaxel presented
September 17, 2015
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."
SOURCE Onyx Pharmaceuticals, Inc.; Bayer HealthCare Pharmaceuticals Inc.