48th Annual Meeting of the American Society of Clinical Oncology (ASCO): Bayer to Present Data on Late-Stage Oncology Compounds at ASCO 2012 -- First data from Phase III trial for regorafenib in gastrointestinal stromal tumor (GIST) presented as Late-Breaking Abstract in Oral Abstract Session

-- Updated survival results from Phase III trial for radium-223 chloride in castration-resistant prostate cancer (CRPC) presented as Late-Breaking Abstract in Oral Abstract Session

WAYNE, N.J., May 16, 2012 /PRNewswire/ -- Bayer HealthCare announced today that data on Nexavar® (sorafenib) tablets and several of its investigational oncology compounds will be presented in a scientific forum at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO), June 1-5, in Chicago, IL. These data, including oral presentations of two Late-Breaking Abstracts on the late-stage compounds regorafenib and radium-223 chloride, reflect Bayer's commitment to oncology research and development.

"We are pleased to present Phase III data in cancers that warrant further development. At Bayer, we are dedicated to researching new treatments for people living with cancer," said Pamela A. Cyrus, M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals.

Notable studies evaluating Bayer's oncology products and compounds at ASCO include:

Regorafenib

  • Randomized Phase 3 Trial of regorafenib in patients (pts) with metastatic and/or unresectable gastrointestinal stromal tumor (GIST) progressing despite prior treatment with at least imatinib (IM) and sunitinib (SU) – GRID trial
    • Late-breaking Abstract #LBA10008, Oral Abstract Session: Sarcoma
    • Monday, June 4, 5:30 p.m.5:45 p.m., Theater S406
  • Phase 3 CORRECT trial of regorafenib in metastatic colorectal cancer (mCRC)
    • Abstract #3502, Oral Abstract Session: Gastrointestinal (Colorectal) Cancer
    • Sunday, June 3, 10:15 a.m.10:30 a.m., E Hall D1

Radium-223 Chloride

  • Final overall survival analysis results from the Phase III, double-blind, randomized, multinational study of radium-223 chloride (Alpharadin) in the treatment of patients with castration-resistant prostate cancer (CRPC) with bone metastases (ALSYMPCA)
    • Late-breaking Abstract #LBA4512, Oral Abstract Session: Genitourinary (Prostate) Cancer
    • Tuesday, June 5, 10:45 a.m.11:00 a.m., E Arie Crown Theater
  • Radium-223 chloride (Ra-223) impact on skeletal-related events (SREs) & ECOG performance status (PS) in patients with castration-resistant prostate cancer (CRPC) with bone metastases: interim results of a Phase III trial (ALSYMPCA)
    • Abstract #4551, Poster Discussion: Genitourinary (Prostate) Cancer
    • Poster Discussion: Monday, June 4, 11:30 a.m.12:30 p.m., E Arie Crown Theater
    • Poster Session: Monday, June 4, 8:00 a.m.12:00 p.m., E450A, Poster Board 5

BAY 86-9766

  • A Phase II trial of MEK inhibitor BAY 86-9766 in combination with sorafenib as first-line systemic treatment for patients with unresectable hepatocellular carcinoma (HCC)
    • Abstract #4103, General Poster Session: Gastrointestinal (Noncolorectal) Cancer
    • Monday, June 4, 8:00 a.m.12:00 p.m., S Hall A2, Poster Board 48F

Regorafenib and radium-223 chloride are investigational agents and are not approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) or other Health Authorities. 

About Nexavar
Nexavar is approved in the U.S. for the treatment of patients with unresectable liver cancer and for the treatment of patients with advanced kidney cancer. Nexavar inhibits both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to inhibit members of two classes of kinases thought 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 currently approved in more than 100 countries.

Nexavar is also being evaluated by the companies, international study groups, government agencies and individual investigators.

Important Safety Considerations for Patients Taking Nexavar

Nexavar in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer. Nexavar may cause fetal harm when administered to a pregnant woman. Women of childbearing potential are advised to avoid becoming pregnant and female patients should also be advised against breastfeeding while receiving Nexavar.

Cardiac ischemia and/or myocardial infarction may occur. Temporary or permanent discontinuation of Nexavar should be considered in patients who develop cardiac ischemia and/or myocardial infarction. Gastrointestinal perforation was an uncommon adverse reaction and has been reported in less than 1% of patients taking Nexavar.

Uncommon but serious adverse reactions, including keratoacanthomas/squamous cell cancer of the skin and Stevens-Johnson Syndrome, have been reported in clinical trials.

An increased risk of bleeding may occur following Nexavar administration. If bleeding necessitates medical intervention, consider discontinuation of Nexavar. Hypertension may occur early in the course of treatment. Monitor blood pressure weekly during the first 6 weeks and periodically thereafter and treat, as required.

Hand-foot skin reaction and rash are common and management may include topical therapies for symptomatic relief. In cases of any severe or persistent adverse reactions, temporary treatment interruption, dose modification, or permanent discontinuation of Nexavar should be considered. Temporary interruption of Nexavar therapy is recommended in patients undergoing major surgical procedures. Nexavar can prolong the QT/QTc interval and increase the risk for ventricular arrhythmias. Avoid use in patients with congenital long QT syndrome and monitor patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities.

Elevations in serum lipase and reductions in serum phosphate of unknown etiology have been associated with Nexavar. Monitor patients taking concomitant warfarin regularly for changes in prothrombin time, INR, or clinical bleeding episodes. Avoid concomitant use of strong CYP3A4 inducers, when possible, because inducers can decrease the systemic exposure of sorafenib.  Nexavar exposure decreases when co-administered with oral neomycin. Effects of other antibiotics on Nexavar pharmacokinetics have not been studied.

Most common adverse reactions reported for Nexavar-treated patients vs placebo-treated patients in unresectable HCC, respectively, were: diarrhea (55% vs 25%), fatigue (46% vs 45%), abdominal pain (31% vs 26%), weight loss (30% vs 10%), anorexia (29% vs 18%), nausea (24% vs 20%), and hand-foot skin reaction (21% vs 3%). Grade 3/4 adverse reactions were 45% vs 32%.

Most common adverse reactions reported for Nexavar-treated patients vs placebo-treated patients in advanced RCC, respectively, were: diarrhea (43% vs 13%), rash/desquamation (40% vs 16%), fatigue (37% vs 28%), hand-foot skin reaction (30% vs 7%), alopecia (27% vs 3%),and nausea (23% vs 19%). Grade 3/4 adverse reactions were 38% vs 28%. During postapproval use of Nexavar, the following adverse drug reactions have been identified: angioedema and drug-induced hepatitis, including reports of hepatic failure and death.

For information about Nexavar including U.S. Nexavar prescribing information, visit www.nexavar.com or call 1.866.NEXAVAR (1.866.639.2827).

About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare provides products for General Medicine, Hematology, Neurology, Oncology and Women's Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

Bayer®, the Bayer Cross® and Nexavar® are registered trademarks of Bayer. 

Intended for U.S. media only.

Forward-Looking Statement
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup 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. 

SOURCE Bayer HealthCare



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