Bayer to Showcase Latest Oncology Research at ESMO 2016 Congress

Includes a late-breaking oral presentation of results from the Phase III RESORCE trial evaluating regorafenib in unresectable hepatocellular carcinoma (HCC) / Additional presentations include early pipeline data on Bayer’s investigational oral pan-fibroblast growth factor receptor (FGFR) inhibitor, and further data on radium-223 dichloride in metastatic castration-resistant prostate cancer (mCRPC)

Abstracts: LBA28, 506P, 516P, 474P, 507P, 1415P, 1556P, 1559P, 752P, 750P, 751P, 310TiP, 360O, 1426PD

Berlin, September 28, 2016 – Bayer announced today that the latest research across its growing oncology portfolio will be presented at the European Society of Medical Oncology (ESMO) 2016 Congress taking place on October 7-11 in Copenhagen, Denmark. The data span a variety of difficult-to-treat cancers and include two oral presentations and 12 posters. Findings from the Phase III RESORCE clinical trial evaluating regorafenib in patients with unresectable hepatocellular carcinoma (HCC) who progressed after treatment with sorafenib will be presented as an oral late-breaking abstract. Another oral presentation will reveal the first-in-human dose-escalation results of the company’s investigational compound BAY 1163877, a pan-fibroblast growth factor receptor (FGFR) inhibitor, in advanced solid tumors. 

Data presentations also include further results for Xofigo® (radium-223 dichloride) from an international expanded access program and a prospective retreatment study in men with metastatic castration-resistant prostate cancer. 

Together, these data reflect Bayer’s approach to research and development, focusing on areas with high unmet medical need, such as prostate and liver cancer, as well as first-in-class opportunities across the company’s research platforms.

Bayer studies at ESMO 2016 include the following:

Regorafenib
• Efficacy and safety of regorafenib (REG) versus placebo (PBO) in patients (pts) with hepatocellular carcinoma (HCC) progressing on sorafenib: Results of the international, randomized phase 3 RESORCE trial
o Late-breaking Oral LBA28, Session: Gastrointestinal tumors, non-colorectal (Copenhagen)
o Saturday, October 8, 2016, 8:20 am (CEST)
• Subgroup analysis of patients with metastatic colorectal cancer (mCRC) treated with regorafenib (REG) in the phase IIIb CONSIGN trial who had progression-free survival (PFS) >4 months (m)
o Poster 506P, Session: Poster Display (Hall E)
o Saturday, October 8, 2016, 1:00 pm – 2:00 pm (CEST) 
• Characteristics of patients with metastatic colorectal cancer (mCRC) treated with regorafenib (REG) who had progression-free survival (PFS) >4 months (m): Subgroup analysis of the phase III CORRECT trial
o Poster 516P, Session: Poster Display (Hall E)
o Saturday, October 8, 2016, 1:00 pm – 2:00 pm (CEST)
• A phase I study to determine the effect of regorafenib on the pharmacokinetics (PK) of substrates of P-glycoprotein (P-gp; digoxin) and breast cancer resistant protein (BCRP; rosuvastatin) in patients with advanced solid tumors
o Poster 474P, Session: Poster Display (Hall E)
o Saturday, October 8, 2016, 1:00 pm – 2:00 pm (CEST)
• A phase 1 study evaluating the pharmacokinetics (PK) and safety of regorafenib (REG) in patients with advanced solid tumors with severe renal impairment (SRI)
o Poster 507P, Session: Poster Display (Hall E)
o Saturday, October 8, 2016, 1:00 pm – 2:00 pm (CEST) 
• Long-term safety of regorafenib (REG) in advanced gastrointestinal stromal tumors (GIST): Updated safety data of the phase 3 GRID trial
o Poster 1415P, Session: Poster Display (Hall E)
o Monday, October 10, 2016, 1:00 pm – 2:00 pm (CEST)
• Evaluation of exposure of regorafenib and its metabolites in cancer patients with renal impairment by modelling, simulation, and clinical study
o Poster 1556P, Session: Poster Display (Hall E)
o Monday, October 10, 2016, 1:00 pm – 2:00 pm (CEST)
• Evaluation of exposure of regorafenib and its metabolites in pediatric patients by modeling, simulation, and clinical study
o Poster 1559P, Session: Poster Display (Hall E)
o Monday, October 10, 2016, 1:00 pm – 2:00 pm (CEST)

Radium-223 Dichloride
• Radium-223 Re-Treatment From an International, Prospective, Open-Label Study in Patients With Castration-Resistant Prostate Cancer and Bone Metastases
o Poster 752P, Session: Poster Display (Hall E)
o Sunday, October 9, 2016, 1:00 pm – 2:00 pm (CEST)
• Radium-223 with concomitant bone-targeting agents in mCRPC patients treated in an international early access program (EAP)
o Poster 750P, Session: Poster Display (Hall E)
o Sunday, October 9, 2016, 1:00 pm – 2:00 pm (CEST) 
• Changes in alkaline phosphatase (ALP) dynamics and overall survival (OS) in metastatic castration-resistant prostate cancer (mCRPC) patients treated with radium-223 in an international early access program (EAP)
o Poster 751P, Session: Poster Display (Hall E)
o Sunday, October 9, 2016, 1:00 pm – 2:00 pm (CEST) 
• A phase 2 randomized, double-blind, placebo-controlled trial of radium-223 dichloride with exemestane and everolimus in patients with HER2–negative hormone receptor–positive breast cancer and bone metastases
o Trial in Progress 310TiP, Session: Poster Display (Hall E)
o Monday, October 10, 2016, 1:00 pm – 2:00 pm (CEST) 

Pipeline
• Phase I study of the pan-fibroblast growth factor receptor (FGFR) inhibitor BAY 1163877 with expansion cohorts for subjects based on tumor FGFR mRNA expression levels
o Oral 360O, Proffered Paper session: Developmental therapeutics (Rome)
o Saturday, October 8, 2016, 12:00 – 12:15 pm (CEST)
• Phase II study of roniciclib in combination with cisplatin/etoposide or carboplatin/etoposide as first-line therapy in subjects with extensive-stage disease small cell lung cancer (ED-SCLC)
o Poster 1426PD, Poster Discussion Session: Non-metastatic NSCLC and other thoracic malignancies (Berlin)
o Monday, October 10, 2016, 3:20 pm (CEST)

About Regorafenib (Stivarga®)
Regorafenib is an oral multikinase inhibitor that potently blocks protein kinases involved in tumor angiogenesis (VEGFR1, -2, -3, TIE2), oncogenesis (KIT, RET, RAF-1, BRAF), metastasis (VEGFR3, PDGFR, FGFR) and tumor immunity (CSF1R).

Regorafenib is approved under the brand name Stivarga® in more than 90 countries worldwide, including the U.S., countries of the EU and Japan for the treatment of metastatic colorectal cancer. The product is also approved in over 80 countries, including the U.S., 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 mCRC who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy, as well as for the treatment of adult patients with unresectable or metastatic GIST who progressed on or are intolerant to prior treatment with imatinib and sunitinib.

Regorafenib is a compound developed by Bayer. In 2011, Bayer entered into an agreement with Onyx, now an Amgen subsidiary, under which Onyx receives a royalty on all global net sales of regorafenib in oncology.

About Radium-223 Dichloride (Xofigo®) 
Radium-223 dichloride (radium-223) is an alpha particle-emitting therapeutic anti-tumor pharmaceutical. It 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 minimizes damage to the surrounding normal tissue.

Radium-223 dichloride has been approved under the brand name Xofigo® in 50 countries worldwide, including the U.S., countries of the EU and Japan. In countries of the EU, it is approved for the treatment of adults with castration-resistant prostate cancer, 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 and patients with multiple myeloma.

About Sorafenib (Nexavar®) 
Sorafenib, an oral anti-cancer therapy, has been shown in preclinical studies 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.

Sorafenib is marketed under the brand name Nexavar® and is approved for the treatment of certain forms of hepatocellular carcinoma (HCC), renal cell carcinoma (RCC) and differentiated thyroid carcinoma (DTC). Whilst licenses may differ from country to country, across all indications Nexavar is approved in more than 100 countries worldwide. In countries of the EU, Nexavar is approved for the treatment of (HCC); for the treatment of patients with advanced 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. 

Bayer has worldwide exclusive marketing rights for Nexavar, with Bayer paying a royalty on US sales to Amgen Inc. Outside the U.S., Bayer and Amgen share profits globally, excluding Japan.

About BAY 1163877
BAY 1163877 is an oral, potent small molecule pan-fibroblast growth factor receptor (FGFR) inhibitor of FGFRs 1-3 with antineoplastic activities in preclinical studies. BAY 1163877 is currently being investigated in patients with advanced solid tumors with high FGFR mRNA expression.

BAY 1163877 is not approved by the European Medicines Agency, U.S. Food and Drug Administration or any other health authority.

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer 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 prioritizes targets and pathways, with the potential to impact the way that cancer is treated.

Bayer: Science For A Better Life

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. In fiscal 2015, the Group employed around 117,000 people and had sales of EUR 46.3 billion. Capital expenditures amounted to EUR 2.6 billion, R&D expenses to EUR 4.3 billion. These figures include those for the high-tech polymers business, which was floated on the stock market as an independent company named Covestro on October 6, 2015. For more information, go to www.bayer.com.

Our online press service is just a click away: press.bayer.com
Follow us on Facebook: http://www.facebook.com/pharma.bayer
Follow us on Twitter: https://twitter.com/BayerPharma

Find more information at www.pharma.bayer.com.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

To read more Press Release articles, click here.