Bayer HealthCare announced that data from its oncology portfolio, including Stivarga (regorafenib) tablets, Nexavar (sorafenib) tablets and Xofigo (radium Ra 223 dichloride) injection, will be presented at the European Society for Medical Oncology (ESMO) 2014 Congress taking place September 26 - 30 in Madrid, Spain. These data include an oral presentation on the phase III CONCUR trial evaluating the efficacy and safety of regorafenib in Asian patients with previously treated metastatic colorectal cancer (mCRC).
“Bayer’s presence at this global conference demonstrates our commitment and progress in exploring new treatment options for cancer patients around the world across various tumor types through both our robust portfolio and pipeline,” said Dr. Joerg Moeller, Member of the Bayer HealthCare Executive Committee and Head of Global Development.
Notable studies evaluating Bayer's oncology products at ESMO 2014 are listed below. Regorafenib CONCUR: A randomised, placebo-controlled phase 3 study of regorafenib (REG) monotherapy in Asian patients with previously treated metastatic colorectal cancer (mCRC) Oral Presentation 500O, Proffered Paper Session: Gastrointestinal tumors, colorectal, September 27.
REBECCA: A large cohort study of Regorafenib (REG) in the real-life setting in patients (pts) previously treated for metastatic colorectal cancer (mCRC).Abstract 602P, Poster Display Session: Gastrointestinal tumors, colorectal. The Cost of Survival Gains in Metastatic Colorectal Cancer (mCRC) in Four European Countries Abstract 604P_PR, Poster Display Session: Gastrointestinal tumours, colorectal. A prospective, observational trial to further assess safety and efficacy of regorafenib in patients with metastatic colorectal cancer (mCRC) in routine clinical practice (CORRELATE). Correlation of sorafenib exposure with safety and efficacy from pivotal clinical trials in hepatocellular carcinoma (HCC) and renal cell cancer (RCC) Health economic analysis of the randomised multicentre phase II trial SAKK 77/08: sorafenib with or without everolimus in patients with unresectable hepatocellular carcinoma (HCC)
A phase III randomised, double-blind, trial comparing sorafenib plus capecitabine versus placebo plus capecitabine in the treatment of locally advanced or metastatic HER2-negative breast cancer (RESILIENCE). Final analysis of overall survival per subgroups of HCC patients in the prospective, non-interventional INSIGHT study treated with sorafenib
An international observational study to assess the use of sorafenib after transarterial chemoembolisation (TACE) in patients with hepatocellular carcinoma (HCC): OPTIMIS
ERA 223 a phase 3 trial of radium-223 dichloride (Ra-223) in combination with abiraterone acetate (AA) and prednisone in the treatment of asymptomatic or mildly symptomatic chemotherapy-naïve patients with bone-predominant metastatic castration-resistant prostate cancer (CRPC)
Regorafenib is an oral multi-kinase inhibitor that inhibits various kinases within the mechanisms involved in tumor growth and progression angiogenesis, oncogenesis and the tumour microenvironment. In preclinical studies, regorafenib inhibits several angiogenic VEGF receptor tyrosine kinases that play a role in tumor neoangiogenesis (the growth of new blood vessels). In addition to VEGFR 1-3 it also inhibits various oncogenic and tumor microenvironment kinases including TIE-2, RAF-1, BRAF, BRAFV600, KIT, RET, PDGFR, and FGFR, which individually and collectively impact upon tumor growth, formation of a stromal microenvironment and disease progression.
Regorafenib is approved under the brand name Stivarga in more than 60 countries worldwide, including the US, Europe and Japan for the treatment of metastatic colorectal cancer. The product is also approved in more than 40 countries, including the US, Europe and Japan, for the treatment of metastatic gastrointestinal stromal tumours (GIST).
Regorafenib is a compound developed by Bayer. In 2011, Bayer entered into an agreement with Onyx Pharmaceuticals, Inc., an Amgen subsidiary, under which Onyx receives a royalty on all global net sales of regorafenib in oncology.
Sorafenib, an oral anti-cancer therapy, is approved under the brand name Nexavar in more than 100 countries worldwide. In Europe, Nexavar is approved for the treatment of hepatocellular carcinoma (HCC); 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; and for progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.
In preclinical studies, sorafenib has been shown to inhibit multiple kinases thought to be involved in both cell proliferation (growth) and angiogenesis (blood supply) two important processes that enable cancer growth. These kinases include Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.
Nexavar is co-developed by Onyx Pharmaceuticals, Inc., an Amgen subsidiary, and Bayer, except in Japan where Bayer manages all development. The companies co-promote Nexavar in the US Outside of the US., excluding Japan, Bayer has exclusive marketing rights, and Bayer and Onyx share profits globally.
Radium-223 dichloride (radium-223) is a therapeutic alpha particle-emitting pharmaceutical with an anti-tumour effect on bone metastases. Radium-223 mimics calcium and selectively targets bone, specifically areas of bone metastases, by forming complexes with the bone mineral hydroxyapatite. The high linear energy transfer of alpha emitters leads to a high frequency of double-strand DNA breaks in adjacent tumor cells, resulting in a potent cytotoxic effect. The alpha particle range from radium-223 is less than 100 micrometers, which minimises damage to the surrounding normal tissue.
Radium-223 dichloride has been approved under the brand name Xofigo in more than 40 countries worldwide, including the US and the EU. In Europe, it is approved for the treatment of adults with CRPC, symptomatic bone metastases and no known visceral metastases.
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now includes three oncology products and several other compounds in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritises targets and pathways with the potential to impact the way that cancer is treated.