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Bayer AG. (5/18/17). "Press Release: 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO). Bayer to Highlight Oncology Franchise Research at ASCO 2017 [Not intended for U.S. and UK Media]". Berlin.

Organisations Organisation Bayer AG
  Group Bayer (Group)
  Organisation 2 American Society of Clinical Oncology (ASCO)
Products Product ASCO 2017 Chicago
  Product 2 copanlisib (BAY 80-6946)
     


Not intended for U.S. and UK Media:


Features findings from the pivotal Phase II trial of the investigational compound copanlisib in patients with relapsed or refractory non-Hodgkin’s lymphoma (NHL), as well as latest research on sorafenib, regorafenib, radium-223 dichloride and darolutamide (ODM-201)

Abstracts: 5042, 3567, 3551, 4078, 6084, TPS5092, 7535, 7536, 7563


Bayer announced today that the latest research from across its growing oncology portfolio will be presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place June 2-6 in Chicago, Illinois (USA).

The Bayer data being presented at ASCO span prostate, colorectal, liver and thyroid cancers, as well as lymphomas, and includes a subgroup analysis from the Phase II CHRONOS-1 trial of copanlisib in patients with relapsed or refractory follicular lymphoma (FL), the most common subtype of indolent non-Hodgkin’s lymphoma (iNHL). Additional copanlisib data includes a Phase II study in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), an aggressive, fast-growing form of NHL. This week, the U.S. Food and Drug Administration (FDA) granted Priority Review designation for Bayer’s New Drug Application (NDA) for copanlisib for the treatment of relapsed or refractory FL patients who have received at least two prior therapies, based on the CHRONOS-1 data.

Other data of note includes interim results from the observational REASSURE trial examining real-world patient characteristics and treatment patterns with Xofigo® (radium-223 dichloride) and a biomarker analysis from the Phase III RESORCE trial of Stivarga® (regorafenib) tablets in hepatocellular carcinoma (HCC). Stivarga recently received approval from the FDA for the treatment of HCC in patients previously treated with sorafenib, making it the first new treatment for HCC in a decade.

Notable Bayer studies at ASCO 2017 include the following:

Radium-223 Dichloride
• Patient (pt) Characteristics and Treatment Patterns in the Radium (Ra)-223 REASSURE Observational Study
o Abstract #5042, Poster session: Genitourinary (Prostate) cancer
o Monday, June 5, 2017, 1:15 PM - 4:45 PM

Regorafenib
• Impact of tumor location on outcomes in patients with metastatic colorectal cancer (mCRC) treated with regorafenib (REG): An interim analysis from the prospective, observational CORRELATE study
o Abstract #3567, Poster session: Gastrointestinal (Colorectal) Cancer
o Saturday June 3, 2017, 8:00 AM - 11:30 AM
• Hand–foot skin reaction (HFSR) and outcomes in the phase 3 CORRECT trial of regorafenib for metastatic colorectal cancer (mCRC)
o Abstract #3551, Poster session: Gastrointestinal (Colorectal) Cancer
o Saturday June 3, 2017, 8:00 AM - 11:30 AM
• Efficacy of regorafenib (REG) in patients with hepatocellular carcinoma (HCC) in the phase 3 RESORCE trial according to alpha-fetoprotein (AFP) and c-Met levels as predictors of poor prognosis
o Abstract #4078, Poster session: Gastrointestinal (nonCRC)
o Saturday, June 3, 2017, 8:00 AM - 11:30 AM

Sorafenib
• Interim baseline characteristics from RIFTOS MKI, a global non-interventional study assessing the use of multikinase inhibitors (MKIs) in the treatment of patients with asymptomatic radioactive iodine-refractory differentiated thyroid cancer (RAI-R DTC)
o Abstract #6084, Poster session: Head and Neck Cancer (Hall A)
o Monday, June 5, 2017 1:15 PM - 4:45 PM

Darolutamide
• ARASENS phase 3 trial of ODM-201 in men with metastatic hormone-sensitive prostate cancer (mHSPC)
o Abstract #TPS5092, Poster session: Genitourinary (Prostate) Cancer (Hall A)
o Monday, June 5, 2017 1:15 PM - 4:45 PM

Copanlisib
• Copanlisib in patients with relapsed or refractory follicular lymphoma
o Poster #7535, Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
o Monday, June 5, 2017, 8:00 AM - 11:30 AM
• Phase II study of single-agent copanlisib in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
o Poster #7536, Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
o Monday, June 5, 2017, 8:00 AM - 11:30 AM

Other
• Treatment patterns among elderly follicular lymphoma patients diagnosed between 2000 and 2011: An analysis of linked SEER-Medicare data.
o Poster #7563, Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
o Monday, June 5, 2017, 8:00 AM - 11:30 AM


About Radium-223 Dichloride (Xofigo®)

Radium-223 dichloride (radium-223) is is a Targeted Alpha Therapy. 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 more than 50 countries worldwide, including the U.S., countries of the European Union (EU) and Japan. In countries of 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 and patients with multiple myeloma.


About Regorafenib (Stivarga®)

Regorafenib is an oral multi-kinase inhibitor that potently blocks multiple 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 already approved under the brand name Stivarga® in more than 90 countries worldwide, including the U.S., countries of the EU, China and Japan for the treatment of mCRC. The product is also approved in over 80 countries, including the U.S., countries of the EU, China and Japan, for the treatment of metastatic GIST. In April 2017, Stivarga was approved in the U.S. for use in patients with HCC who have been previously treated with sorafenib. Additional regulatory filings for Stivarga in HCC are under review in countries around the world, including the EU, Japan and China, with decisions in the EU and Japan regions expected later this year. 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 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, renal cell carcinoma and differentiated thyroid carcinoma. Whilst licenses may differ from country to country, across all indications Nexavar is approved in more than 100 countries worldwide. In countries of the European Union, 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.

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 Darolutamide

Darolutamide is a novel investigational oral androgen receptor (AR) antagonist with a unique chemical structure designed to block the growth of cancer cells by binding to the AR with high affinity and inhibiting the receptor function. In preclinical studies, darolutamide and its main circulating metabolite were also active in known AR mutations, such as W742L and F877L, with negligible blood-brain barrier penetration.

Darolutamide demonstrated promising anti-tumor activity in a Phase I/II study in patients with metastatic castration-resistant prostate cancer (mCRPC). It is not approved by the U.S. Food and Drug Administration, the European Medicines Agency or any other health authority.


About Copanlisib

Copanlisib is a novel pan-class I PI3K inhibitor with predominant inhibitory activity against PI3K-a and PI3K-d isoforms, being developed by Bayer. The PI3K pathway is involved in cell growth, survival and metabolism, and its dysregulation plays an important role in non-Hodgkin’s lymphoma (NHL). Copanlisib is administered as a 1-hour infusion on Days 1, 8 and 15 of each 28-day treatment cycle.

Copanlisib has shown promising clinical activity in Phase I and Phase II studies in heavily pretreated patients with recurrent indolent and aggressive NHL. The broad clinical development program also includes Phase III studies in indolent NHL patients who have relapsed or are refractory to prior therapies. Information about these trials can be found at www.clinicaltrials.gov and www.chronostrials.com.

The U.S. Food and Drug Administration (FDA) granted Priority Review designation for Bayer’s New Drug Application (NDA) for copanlisib for the treatment of relapsed or refractory FL patients who have received at least two prior therapies, based on the CHRONOS-1 data.Copanlisib has also been granted Orphan Drug Designation for FL as well as of splenic, nodal, and extranodal subtypes of marginal zone lymphoma. The compound is not approved by the FDA, the European Medicines Agency 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 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 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 2016, the Group employed around 115,200 people and had sales of EUR 46.8 billion. Capital expenditures amounted to EUR 2.6 billion, R&D expenses to EUR 4.7 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.

Find more information at www.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.

   
Record changed: 2017-05-24

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