Date: 2011-05-19
Type of information: Results
phase: 2b
Announcement: results
Company: Bayer (Germany) Onyx Pharmaceuticals (USA)
Product: Nexavar® (sorafenib)
Action
mechanism: Nexavar® inhibits processes involved in both the tumor cell and tumor vasculature. In preclinical studies, Nexavar® has been shown to target members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) - two important processes that enable cancer growth. These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR B, KIT, FLT-3 and RET.
Disease: locally advanced or metastatic breast cancer previously treated with a bevacizumab containing regimen
Therapeutic area: Cancer - Oncology
Country:
Trial
details: This Phase IIb, randomized, double-blind, placebo-controlled trial evaluated Nexavar® in combination with chemotherapeutic agent, agents gemcitabine (1000 mg/m2) or capecitabine (1000 mg/m2) in 160 patients with locally advanced or metastatic HER-2 negative breast cancer who had progressed on bevacizumab. Patients were randomized to receive 400 mg of oral Nexavar® or matching placebo twice daily, in addition to chemotherapeutic agents - gemcitabine or capecitabine. The primary endpoint was progression-free survival, and secondary endpoints included overall survival, time-to-progression and safety.
Latest
news: Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals have announced results from a Phase IIb trial evaluating Nexavar® (sorafenib) tablets in patients with locally advanced or metastatic breast cancer previously treated with a bevacizumab containing regimen, which showed that Nexavar® was associated with statistically significant improvements in progression-free survival (the primary endpoint of the study) and time-to-progression. The study evaluated Nexavar® in combination with a chemotherapeutic agent, either, gemcitabine or capecitabine. The data will be presented during an oral session at the 2011 Annual Meeting of the American Society of Clinical Oncology (ASCO), June 3-7, in Chicago, IL.
Clifford Hudis, M.D., Chief of the Breast Cancer Medicine Service and attending physician at the Memorial Sloan-Kettering Cancer Center, as well as Professor of Medicine at Weill Cornell Medical College, reported that patients receiving Nexavar® in addition to standard chemotherapy agents obtained a progression-free survival benefit with median 3.4 months to progression versus 2.7 (HR=0.65, one-sided p-value=0.01). Time-to-progression was similarly improved from a median of 3.6 months from 2.7 months (HR=0.64, one-sided p-value =0.009) in this pre-treated population. The safety and tolerability profile of the combination was consistent with the previous experience with each agent. The most commonly reported Grade 3 adverse events were hand-foot skin reaction (39 percent), neutropenia (16 percent) and stomatitis (10 percent).
This Phase IIb is part of a company-supported clinical development program known as TIES (Trials to Investigate the Effects of Sorafenib in Breast Cancer), where Nexavar® is being evaluated in four investigator-/cooperative group-sponsored Phase II trials for patients with advanced breast cancer and in a variety of treatment settings. The remaining ongoing trial under this program is evaluating Nexavar® plus docetaxel and/or letrozole in the first-line setting.
