Date: 2014-07-25
Type of information: Results
phase: 3
Announcement: results
Company: Bayer Healthcare (Germany) Onyx Pharmaceuticals (USA)
Product: Nexavar® (sorafenib)
Action
mechanism: Oral multi-kinase inhibitor 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. Nexavar® is already approved in Europe for the treatment of hepatocellular carcinoma and for the treatment of patients with advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy. The drug is also being evaluated by the companies, international study groups, government agencies and individual investigators as a single agent or combination treatment in a range of cancers, including lung, thyroid, ovarian and colorectal cancer and as an adjuvant therapy for liver and kidney cancer.
Disease: advanced breast cancer
Therapeutic area: Cancer - Oncology
Country: more than 20 countries, including USA, Brazil, Japan, Australia
Trial
details: The RESILIENCE (Phase III TRial Comparing CapecitabinE in Combination with SorafenIb or PLacebo for Treatment of Locally Advanced or MetastatIc HER2-Negative Breast CancEr) trial is a randomized, double-blind, placebo-controlled Phase III study planned to enroll 519 patients in more than 20 countries, including the United States, Brazil, Japan and Australia. The study will evaluate Nexavar® in combination with capecitabine in patients with locally advanced or metastatic HER-2 negative breast cancer who are resistant to or have failed prior taxane and an anthracycline or for whom further anthracycline is not indicated.
The primary endpoint of the study is progression-free survival. Secondary endpoints include overall survival, time to progression, and safety. Patients will receive 600 mg of oral Nexavar or matching placebo daily on a continuous schedule, in addition to 1000mg/m2 of capecitabine twice daily for 14 days of a 21 day cycle. Dose escalation to 800 mg of oral Nexavar daily and capecitabine 1250 mg/m2 twice daily will be permitted depending on tolerance. (NCT 01234337).
Latest
news: * On July 25, 2014, Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, an Amgen subsidiary, announced that an investigational Phase III trial of sorafenib (Nexavar®) tablets plus capecitabine in patients with advanced breast cancer did not meet its primary endpoint of improving progression-free survival (PFS). The study, called RESILIENCE, evaluated the efficacy and safety of sorafenib in combination with capecitabine, compared to placebo plus capecitabine, in patients with HER2 negative breast cancer who are resistant to or have failed prior taxane, and are resistant to or have failed an anthracycline or for whom further anthracycline therapy is not indicated. Based on initial review of the data, the types of adverse events observed were generally comparable with those known for either sorafenib or capecitabine. Detailed efficacy and safety analyses from this study are expected to be presented at an upcoming scientific congress.
* On February 24, 2011, Bayer HealthCare and Onyx Pharmaceuticals have begun enrolling patients in a Phase III randomized, double-blind, placebo-controlled trial evaluating Nexavar® (sorafenib) tablets in combination with the oral chemotherapeutic agent, capecitabine, versus placebo plus capecitabine for the treatment of patients with advanced breast cancer. This Phase III trial was initiated based on the results from a cooperative group-sponsored Phase II clinical trial evaluating Nexavar® in combination with capecitabine in patients with advanced breast cancer.
