Bayer HealthCare, one of the world’s leading, innovative companies in the healthcare and medical products industry, announced that data from its oncology portfolio will be presented at the 2015 European Cancer Congress (ECC2015), September 25 - 29, in Vienna, Austria.
These data include further analyses from the CONSIGN and CONCUR trials that reaffirm the clinical benefits of Stivarga (regorafenib) tablets in metastatic colorectal cancer (mCRC), and additional overall survival findings for Xofigo (radium-223 dichloride) injection in metastatic castration-resistant prostate cancer from the phase III ALSYMPCA trial and the US expanded access programme (EAP).
In addition, Bayer will present early clinical findings on its investigational compound roniciclib (BAY-1000394), a pan-cyclin-dependent kinase (CDK) inhibitor with broad spectrum activity targeting tumorigenesis. Roniciclib is currently in phase II clinical development as a first-line therapy in combination with chemotherapy for extensive disease small cell lung cancer (ED-SCLC).
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 in countries of the EU. In the EU, it is approved for the treatment of adults with CRPC, symptomatic bone metastases and no known visceral metastases. Radium 223 is also being studied in additional trials for men with prostate cancer as well as in phase II studies for women with breast cancer.
Regorafenib is an oral multi-kinase inhibitor that inhibits various kinases within the mechanisms involved in tumour 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 tumour 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 tumour growth, formation of a stromal microenvironment and disease progression.
Regorafenib is approved under the brand name Stivarga in more than 80 countries worldwide, including the US, countries of the EU and Japan, for the treatment of metastatic colorectal cancer. The product is also approved in more than 60 countries, including the US, countries of the EU and Japan, for the treatment of metastatic gastrointestinal stromal tumors (GIST). In the EU, Stivarga is indicated for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies, as well as unresectable or metastatic gastrointestinal stromal tumors (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib. Regorafenib is also being investigated in a number of tumour types, including a phase III trial in hepatocellular carcinoma.
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.
Roniciclib (BAY-1000394) is an oral cyclin dependent kinase (CDK) inhibitor with potential antineoplastic activity. Roniciclib selectively binds to and inhibits the activity of CDK1/Cyclin B, CDK2/Cyclin E, CDK4/Cyclin D1, CDK6/Cyclin D3, and CDK9/Cyclin T1, serine/threonine kinases that play key roles in the regulation of tumor cell proliferation and survival.
Roniciclib is currently in phase II of clinical development and is being investigated in multiple tumor types including small cell lung cancer. Roniciclib is not approved by the US Food and Drug Administration, the European Medicines Agency or any other health authority.