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Bayer to Present Data on Multiple Oncology Compounds at the European Cancer Congress (ECCO-ESMO-ESTRO) 2013

September 17, 2013

WHIPPANY, N.J., Sept. 17, 2013 /PRNewswire/ — Bayer HealthCare announced today that data from the company’s oncology portfolio, including Nexavar(®) (sorafenib) tablets, Stivarga(®) (regorafenib) tablets and Xofigo(®) (radium Ra 223 dichloride) injection will be presented at the 2013 European Cancer Congress (ECCO/ESMO/ESTRO), September 28 – October 1, in Amsterdam, Netherlands. These data include an oral presentation of a subanalysis from the Phase III trial of sorafenib in patients with radioactive iodine-refractory differentiated thyroid cancer, an oral presentation and posters on the efficacy and safety of regorafenib, which was recently approved by the European Medicines Agency (EMA), and posters on additional analyses from the pivotal ALSYMPCA trial of radium 223, which was recently approved by the FDA for the treatment of castration-resistant prostate cancer patients, symptomatic bone metastases and no known visceral metastates.

“In the past year, Bayer has transformed its oncology business into a multi-product franchise, expanding the portfolio to include two additional products in three indications addressing unmet medical needs,” said Svetlana Kobina, MD, PhD-VP, Head Global Medical Affairs, Bayer HealthCare Pharmaceuticals. “Along with the data being presented at the European Cancer Congress, the recent approvals of radium 223 in the U.S. and regorafenib in the European Union illustrate our continued dedication to advancing treatment options for patients.”

Sorafenib

    --  Association between tumor BRAF and RAS mutation status and clinical
        outcomes in patients with radioactive iodine (RAI)-refractory
        differentiated thyroid cancer (DTC) randomized to sorafenib or placebo:
        sub-analysis of the phase III DECISION trial
        --  Abstract #3155, Oral Presentation, Proffered Papers Session: Head
            and Neck Cancer
        --  Saturday, September 28, 17:02 PM CEST, Hall 3.1

Regorafenib

    --  Effects of regorafenib therapy on health-related quality of life in
        patients with metastatic colorectal cancer in the phase III CORRECT
        study
        --  Abstract #2156, Oral Presentation, Proffered Paper Session:
            Gastrointestinal Malignancies - Colorectal Cancer II
        --  Sunday, September 29, 9:00AM CEST, RAI Auditorium
    --  Regorafenib dose modifications in patients with metastatic colorectal
        cancer in the phase III CORRECT study
        --  Abstract #2360, Poster Session: Gastrointestinal Malignancies -
            Colorectal Cancer
        --  Sunday, September 29, 2:00-4:30 PM CEST, Hall 4
    --  Time to health status deterioration in regorafenib-treated patients with
        metastatic colorectal cancer (mCRC): a post-hoc analysis of the phase
        III CORRECT study
        --  Abstract #2361, Poster Session: Gastrointestinal Malignancies -
            Colorectal Cancer
        --  Sunday, September 29, 2:00-4:30 PM CEST, Hall 4
    --  Transcript profiling of patient-derived (PD) colorectal cancer (CRC)
        xenografts for the identification of biomarkers for regorafenib (REG;
        BAY 73-4506)
        --  Abstract #2408, Poster Session: Gastrointestinal Malignancies -
            Colorectal Cancer
        --  Sunday, September 29, 2:00-4:30 PM CEST, Hall 4
    --  Time course of adverse events in the phase III GRID study of regorafenib
        in patients with metastatic gastrointestinal stromal tumors (GIST)
        --  Abstract #3827, Poster Session: Sarcoma: Soft Tissue and Bone
        --  Monday, September 30, 9:30 AM-12:00 PM CEST, Hall 4
    --  Health-related quality of life (HRQoL) of patients with advanced
        gastrointestinal stromal tumors (GIST) treated with regorafenib (REG) vs
        placebo (P) in the phase III GRID trial
        --  Abstract #3830, Poster Session: Sarcoma: Soft Tissue and Bone
        --  Monday, September 30, 9:30 AM-12:00 PM CEST, Hall 4
    --  Exposure-efficacy analysis of regorafenib (REG) and its metabolites M-2
        and M-5 in the phase III GRID study in patients (pts) with metastatic
        gastrointestinal stromal tumor (GIST)
        --  Abstract #3831, Poster Session: Sarcoma: Soft Tissue and Bone
        --  Monday, September 30, 9:30 AM-12:00 PM CEST, Hall 4

Radium 223 dichloride

    --  Time to first skeletal-related event (SRE) with radium-223 dichloride
        (Ra-223) in patients with castration-resistant prostate cancer (CRPC)
        and bone metastases: ALSYMPCA trial stratification factors analysis
        --  Abstract #2876, Poster Session: Genitourinary Malignancies -
            Prostate Cancer
        --  Monday, September 30, 9:30 AM-12:00 PM CEST, Hall 4
    --  Hematologic safety of radium-223 dichloride (Ra-223) in the phase 3
        ALSYMPCA trial in castration-resistant prostate cancer (CRPC) patients
        with bone metastases: baseline prognostic factor subgroup analysis
        --  Abstract #2877, Poster Session: Genitourinary Malignancies -
            Prostate Cancer
        --  Monday, September 30, 9:30 AM-12:00 PM CEST, Hall 4
    --  Effects of radium-223 dichloride (Ra-223) on health-related quality of
        life (QOL) outcomes in the phase 3 ALSYMPCA study in patients with
        castration-resistant prostate cancer (CRPC) and bone metastases
        --  Abstract #2878, Poster Session: Genitourinary Malignancies -
            Prostate Cancer
        --  Monday, September 30, 9:30 AM-12:00 PM CEST, Hall 4
    --  Radium-223 dichloride (Ra-223) efficacy and safety in patients with
        castration-resistant prostate cancer (CRPC) with bone metastases: phase
        3 ALSYMPCA study findings stratified by age group
        --  Abstract #2883, Poster Session: Genitourinary Malignancies -
            Prostate Cancer
        --  Monday, September 30, 9:30 AM-12:00 PM CEST, Hall 4

About Nexavar® (sorafenib) Tablets

Nexavar is approved in the U.S. for the treatment of patients with unresectable hepatocellular carcinoma and for the treatment of patients with advanced renal cell carcinoma. Nexavar is thought to inhibit both the tumor cell and tumor vasculature. In in vitro studies, Nexavar 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 currently approved in more than 100 countries. Nexavar is also being evaluated by Bayer and Onyx, international study groups, government agencies and individual investigators in a range of cancers.

Important Safety Considerations For Nexavar® (sorafenib) Tablets

Nexavar in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer.

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.

An increased risk of bleeding may occur following Nexavar administration. If bleeding necessitates medical intervention, consider permanent 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, if 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. Nexavar should be discontinued if Stevens-Johnson Syndrome or toxic epidermal necrolysis are suspected as these may be life threatening.

Gastrointestinal perforation was an uncommon adverse reaction and has been reported in less than 1% of patients taking Nexavar. Discontinue Nexavar in the event of a gastrointestinal perforation.

Patients taking concomitant warfarin should be monitored regularly for changes in prothrombin time (PT), International Normalized Ratio (INR) or clinical bleeding episodes.

Temporary interruption of Nexavar therapy is recommended in patients undergoing major surgical procedures.

Nexavar in combination with gemcitabine/cisplatin is not recommended in patients with squamous cell lung cancer. The safety and effectiveness of Nexavar has not been established in patients with non-small cell lung cancer.

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.

Drug-induced hepatitis with Nexavar may result in hepatic failure and death. Liver function tests should be monitored regularly and in cases of increased transaminases without alternative explanation Nexavar should be discontinued.

Nexavar may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while on Nexavar and female patients should also be advised against breastfeeding while receiving Nexavar.

Elevations in serum lipase and reductions in serum phosphate of unknown etiology have been associated with Nexavar.

Avoid concomitant use of strong CYP3A4 inducers, when possible, because inducers can decrease the systemic exposure of Nexavar. Nexavar exposure decreases when coadministered 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%.

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

About Stivarga® (regorafenib) Tablets

In the United States, Stivarga is indicated for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. It is also indicated for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.

Stivarga is an inhibitor of multiple kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis, and maintenance of the tumor microenvironment.

Stivarga is a Bayer compound developed by Bayer and jointly promoted by Bayer and Onyx in the United States. In 2011, Bayer entered into an agreement with Onyx, under which Onyx receives a royalty on all global net sales of Stivarga in oncology.

For full prescribing information, including BOXED WARNING, visit www.stivarga-us.com.

Important Safety Information For Stivarga® (regorafenib) Tablets

WARNING: HEPATOTOXICITY

    --  Severe and sometimes fatal hepatotoxicity has been observed in clinical
        trials.
    --  Monitor hepatic function prior to and during treatment.
    --  Interrupt and then reduce or discontinue Stivarga for hepatotoxicity as
        manifested by elevated liver function tests or hepatocellular necrosis,
        depending upon severity and persistence.

Severe drug-induced liver injury with fatal outcome occurred in 0.3% of 1200 Stivarga-treated patients across all clinical trials. In metastatic colorectal cancer (mCRC), fatal hepatic failure occurred in 1.6% of patients in the Stivarga arm and in 0.4% of patients in the placebo arm; all the patients with hepatic failure had metastatic disease in the liver. In gastrointestinal stromal tumor (GIST), fatal hepatic failure occurred in 0.8% of patients in the Stivarga arm.

Obtain liver function tests (ALT, AST, and bilirubin) before initiation of Stivarga and monitor at least every 2 weeks during the first 2 months of treatment. Thereafter, monitor monthly or more frequently as clinically indicated. Monitor liver function tests weekly in patients experiencing elevated liver function tests until improvement to less than 3 times the upper limit of normal (ULN) or baseline values. Temporarily hold and then reduce or permanently discontinue Stivarga, depending on the severity and persistence of hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis.

Stivarga caused an increased incidence of hemorrhage. The overall incidence (Grades 1-5) was 21% and 11% with Stivarga vs 8% and 3% with placebo in mCRC and GIST patients, respectively. Fatal hemorrhage occurred in 4 of 632 (0.6%) Stivarga-treated patients and involved the respiratory, gastrointestinal, or genitourinary tracts. Permanently discontinue Stivarga in patients with severe or life-threatening hemorrhage and monitor INR levels more frequently in patients receiving warfarin.

Stivarga caused an increased incidence of hand-foot skin reaction (HFSR) (also known as palmar-plantar erythrodysesthesia [PPE]) and severe rash, frequently requiring dose modification. The overall incidence was 45% and 67% with Stivarga vs 7% and 12% with placebo in mCRC and GIST patients, respectively. Incidence of Grade 3 HFSR (17% vs 0% in mCRC and 22% vs 0% in GIST), Grade 3 rash (6% vs <1% in mCRC and 7% vs 0% in GIST), serious adverse reactions of erythema multiforme (0.2% vs 0% in mCRC), and Stevens-Johnson syndrome (0.2% vs 0% in mCRC) was higher in Stivarga-treated patients. Toxic epidermal necrolysis occurred in 0.17% of 1200 Stivarga -treated patients across all clinical trials. Withhold Stivarga, reduce the dose, or permanently discontinue depending on the severity and persistence of dermatologic toxicity.

Stivarga caused an increased incidence of hypertension (30% vs 8% in mCRC and 59% vs 27% in GIST with Stivarga vs placebo, respectively). Hypertensive crisis occurred in 0.25% of 1200 Stivarga-treated patients across all clinical trials. Do not initiate Stivarga until blood pressure is adequately controlled. Monitor blood pressure weekly for the first 6 weeks of treatment and then every cycle, or more frequently, as clinically indicated. Temporarily or permanently withhold Stivarga for severe or uncontrolled hypertension.

Stivarga increased the incidence of myocardial ischemia and infarction in mCRC (1.2% with Stivarga vs 0.4% with placebo). Withhold Stivarga in patients who develop new or acute cardiac ischemia or infarction, and resume only after resolution of acute cardiac ischemic events if the potential benefits outweigh the risks of further cardiac ischemia.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS) occurred in 1 of 1200 Stivarga-treated patients across all clinical trials. Perform an evaluation for RPLS in any patient presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Confirm the diagnosis of RPLS with MRI and discontinue Stivarga in patients who develop RPLS.

Gastrointestinal perforation or fistula occurred in 0.6% of 1200 patients treated with Stivarga across clinical trials. In GIST, 2.1% (4/188) of Stivarga-treated patients developed gastrointestinal fistula or perforation: of these, 2 cases of gastrointestinal perforation were fatal. Permanently discontinue Stivarga in patients who develop gastrointestinal perforation or fistula.

Treatment with Stivarga should be stopped at least 2 weeks prior to scheduled surgery. Resuming treatment after surgery should be based on clinical judgment of adequate wound healing. Stivarga should be discontinued in patients with wound dehiscence.

Stivarga can cause fetal harm when administered to a pregnant woman. Use effective contraception during treatment and up to 2 months after completion of therapy. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Stivarga, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

The most frequently observed adverse drug reactions (>/=30%) in Stivarga-treated patients vs placebo-treated patients in mCRC, respectively, were: asthenia/fatigue (64% vs 46%), decreased appetite and food intake (47% vs 28%), HFSR/PPE (45% vs 7%), diarrhea (43% vs 17%), mucositis (33% vs 5%), weight loss (32% vs 10%), infection (31% vs 17%), hypertension (30% vs 8%), and dysphonia (30% vs 6%).

The most frequently observed adverse drug reactions (>/=30%) in Stivarga-treated patients vs placebo-treated patients in GIST, respectively, were: HFSR/PPE (67% vs 15%), hypertension (59% vs 27%), asthenia/fatigue (52% vs 39%), diarrhea (47% vs 9%), mucositis (40% vs 8%), dysphonia (39% vs 9%), infection (32% vs 5%), decreased appetite and food intake (31% vs 21%), and rash (30% vs 3%).

For full prescribing information, including BOXED WARNING, visit www.stivarga-us.com.

About Xofigo(®) (radium Ra 223 dichloride) Injection

Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.

Xofigo is an alpha particle-emitting radioactive therapeutic agent with an anti-tumor effect on bone metastases. The active ingredient in Xofigo is the alpha particle-emitting isotope radium-223, which mimics calcium and forms complexes with the bone mineral hydroxyapatite at areas of increased bone turnover, such as bone metastases. The high linear energy transfer of Xofigo may cause double-strand DNA breaks in adjacent cells, resulting in an anti-tumor effect on bone metastases. The alpha particle range from radium-223 dichloride is less than 100 micrometers which may limit the damage to the surrounding normal tissue.

In September 2009, Bayer signed an agreement with Algeta ASA (Oslo, Norway) for the development and commercialization of Xofigo. Under the terms of the agreement, Bayer will develop, apply for health authority approvals worldwide and commercialize Xofigo globally.

Important Safety Information for Xofigo(®) (radium Ra 223 dichloride) Injection

Xofigo is contraindicated in women who are or may become pregnant. Xofigo can cause fetal harm when administered to a pregnant woman.

In the randomized trial, 2% of patients in the Xofigo arm experienced bone marrow failure or ongoing pancytopenia, compared to no patients treated with placebo. There were two deaths due to bone marrow failure. For 7 of 13 patients treated with Xofigo bone marrow failure was ongoing at the time of death. Among the 13 patients who experienced bone marrow failure, 54% required blood transfusions. Four percent (4%) of patients in the Xofigo arm and 2% in the placebo arm permanently discontinued therapy due to bone marrow suppression. In the randomized trial, deaths related to vascular hemorrhage in association with myelosuppression were observed in 1% of Xofigo-treated patients compared to 0.3% of patients treated with placebo. The incidence of infection-related deaths (2%), serious infections (10%), and febrile neutropenia (less than 1%) was similar for patients treated with Xofigo and placebo. Myelosuppression – notably thrombocytopenia, neutropenia, pancytopenia, and leukopenia – has been reported in patients treated with Xofigo.

Monitor patients with evidence of compromised bone marrow reserve closely and provide supportive care measures when clinically indicated. Discontinue Xofigo in patients who experience life-threatening complications despite supportive care for bone marrow failure.

Monitor blood counts at baseline and prior to every dose of Xofigo. Prior to first administering Xofigo, the absolute neutrophil count (ANC) should be greater than or equal to 1.5 × 10(9)/L, the platelet count greater than or equal to 100 × 10(9)/L, and hemoglobin greater than or equal to 10 g/dL. Prior to subsequent administrations, the ANC should be greater than or equal to 1 × 10(9)/L and the platelet count greater than or equal to 50 × 10(9)/L. Discontinue Xofigo if hematologic values do not recover within 6 to 8 weeks after the last administration despite receiving supportive care.

Safety and efficacy of concomitant chemotherapy with Xofigo have not been established. Outside of a clinical trial, concomitant use of Xofigo in patients on chemotherapy is not recommended due to the potential for additive myelosuppression. If chemotherapy, other systemic radioisotopes, or hemibody external radiotherapy are administered during the treatment period, Xofigo should be discontinued.

Xofigo should be received, used, and administered only by authorized persons in designated clinical settings. The administration of Xofigo is associated with potential risks to other persons from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit. Therefore, radiation protection precautions must be taken in accordance with national and local regulations.

The most common adverse reactions (greater than or equal to 10%) in the Xofigo arm vs the placebo arm, respectively, were nausea (36% vs 35%), diarrhea (25% vs 15%), vomiting (19% vs 14%), and peripheral edema (13% vs 10%). Grade 3 and 4 adverse events were reported in 57% of Xofigo?treated patients and 63% of placebo-treated patients. The most common hematologic laboratory abnormalities in the Xofigo arm (greater than or equal to 10%) vs the placebo arm, respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs 53%), leukopenia (35% vs 10%), thrombocytopenia (31% vs 22%), and neutropenia (18% vs 5%)

For full prescribing information visit www.xofigo-us.com.

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.

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.

Nexavar(®), Stivarga(®), Xofigo(®), Bayer(®) and the Bayer Cross(®) are registered trademarks of Bayer.

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


Source: PR Newswire