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– Assay presented includes broadcast cardinal balloon abstracts set on activity admixture larotrectinib for TRK admixture blight beyond assorted bump types in developed and pediatric patients

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Abstracts: LBA30, 824P, 826P, 827P, 828P, 463P, 473P, 701P, 1644P, 710P, 409O, 67P, 1006O, 1056PD, 925TiP, 930TiP

WHIPPANY, N.J., Oct. 9, 2018 /PRNewswire/ — Bayer will present new abstracts from the company’s growing oncology portfolio at the ESMO 2018 Congress (European Society for Medical Oncology) taking abode October 19-23 in Munich, Germany.

Among the assay presented will be an broadcast cardinal balloon abstracts set on larotrectinib, a TRK (tropomyosin receptor kinase) inhibitor in development for the assay of developed and pediatric patients with locally avant-garde or metastatic solid tumors with a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. Bayer and Loxo Oncology, a biopharmaceutical aggregation based in Stamford, Connecticut, are accordingly developing larotrectinib. Larotrectinib is currently beneath assay by the U.S. Aliment and Biologic Administering and the European Medicines Agency, with added filings in added countries underway or actuality planned. The articulate presentation will accommodate adapted analytic aftereffect for the 55 patients who comprise the accumulated ability assay citizenry that supports these all-around authoritative filings and new abstracts for patients afterwards enrolled.

“We attending avant-garde to administering the latest abstracts beyond our oncology portfolio including new assay in attention medicine,” said Scott Z. Fields, M.D., Senior Vice President and Arch of Oncology Development at Bayer. “The abstracts at ESMO reinforce Bayer’s charge to advancing blight therapies to drive allusive advance for patients.”

Bayer will additionally present a accumulated Phase I and II assay of copanlisib, its PI3K inhibitor with inhibitory activity predominantly adjoin the PI3K-alpha and PI3K-delta isoforms, in patients with relapsed or adverse blah B-cell non-Hodgkin’s lymphoma, and new abstracts on rogaratinib in patients with FGFR mRNA-positive arch and close cancer.

In addition, allegation from the Phase III ERA-223 balloon investigating the use of radium Ra 223 dichloride bang in aggregate with abiraterone acetate and prednisone/prednisolone in asymptomatic or minimially appropriate patients with metastatic castration-resistant prostate blight (mCRPC) will be presented as able-bodied as acting after-effects from the prospective, Phase III non-interventional PARABO abstraction analytical appropriate ashen accident (SSE) dynamics in mCRPC patients brash with radium Ra 223 dichloride injection.

Data to be presented on regorafenib accommodate the final after-effects from a prospective, empiric abstraction (CORRELATE) allegory real-world dosing in metastatic colorectal blight (mCRC) patients.

Notable studies from Bayer’s portfolio and activity therapies actuality featured at the ESMO 2018 Congress are listed below:

About Xofigo® (radium Ra 223 dichloride) Injection1Xofigo is adumbrated for the assay of patients with castration-resistant prostate cancer, appropriate cartilage metastases and no accepted belly metastatic disease.

Please see the abounding Prescribing Advice for Xofigo (radium Ra 223 dichloride).

About Stivarga® (regorafenib)2In April 2017, Stivarga was accustomed for use in patients with hepatocellular blight who accept been ahead brash with Nexavar® (sorafenib). In the United States, Stivarga is additionally adumbrated for the assay of patients with metastatic colorectal blight (CRC) who accept been ahead brash with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy. It is additionally adumbrated for the assay of patients with locally advanced, unresectable or metastatic gastrointestinal stromal bump (GIST) who accept been ahead brash with imatinib mesylate and sunitinib malate.

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Regorafenib is a admixture developed by Bayer. In 2011, Bayer entered into an acceding with Onyx, now an Amgen subsidiary, beneath which Onyx receives a ability on all all-around net sales of regorafenib in oncology.

Important Assurance Advice for Stivarga

WARNING: HEPATOTOXICITY

•  Astringent and sometimes baleful hepatotoxicity has occurred in analytic trials.

•  Adviser hepatic activity above-mentioned to and during treatment.

•  Interrupt and again abate or abandon STIVARGA for hepatotoxicity as embodied by elevated    alarmist activity tests or hepatocellular necrosis, depending aloft severity and persistence.

Hepatotoxicity: Astringent drug-induced alarmist abrasion with baleful aftereffect occurred in STIVARGA-treated patients beyond all analytic trials. In best cases, alarmist dysfunction occurred aural the aboriginal 2 months of assay and was characterized by a hepatocellular arrangement of injury. In metastatic colorectal blight (mCRC), baleful hepatic abortion occurred in 1.6% of patients in the STIVARGA arm and in 0.4% of patients in the placebo arm. In gastrointestinal stromal bump (GIST), baleful hepatic abortion occurred in 0.8% of patients in the STIVARGA arm. In hepatocellular blight (HCC), there was no access in the accident of baleful hepatic abortion as compared to placebo.

Liver Activity Monitoring: Obtain alarmist activity tests (ALT, AST, and bilirubin) afore admission of STIVARGA and adviser at atomic every 2 weeks during the aboriginal 2 months of treatment. Thereafter, adviser account or added frequently as clinically indicated. Adviser alarmist activity tests account in patients experiencing animated alarmist activity tests until advance to beneath than 3 times the aerial absolute of accustomed (ULN) or baseline values. Temporarily ascendancy and again abate or assuredly abandon STIVARGA, depending on the severity and chain of hepatotoxicity as embodied by animated alarmist activity tests or hepatocellular necrosis.

Infections: STIVARGA acquired an added accident of infections. The all-embracing accident of infection (Grades 1-5) was college (32% vs 17%) in 1142 STIVARGA-treated patients as compared to the ascendancy arm in randomized placebo-controlled trials. The accident of brand 3 or greater infections in STIVARGA brash patients was 9%. The best accepted infections were urinary amplitude infections (5.7%), nasopharyngitis (4.0%), mucocutaneous and systemic fungal infections (3.3%) and pneumonia (2.6%). Baleful outcomes acquired by infection occurred added generally in patients brash with STIVARGA (1.0%) as compared to patients accepting placebo (0.3%); the best accepted baleful infections were respiratory (0.6% vs 0.2%). Abstain STIVARGA for Brand 3 or 4 infections, or deepening infection of any grade. Resume STIVARGA at the aforementioned dosage afterward resolution of infection.

Hemorrhage: STIVARGA acquired an added accident of hemorrhage. The all-embracing accident (Grades 1-5) was 18.2% in 1142 patients brash with STIVARGA vs 9.5% with placebo in randomized, placebo-controlled trials. The accident of brand 3 or greater drain in patients brash with STIVARGA was 3.0%. The accident of baleful hemorrhagic contest was 0.7%, involving the axial afraid arrangement or the respiratory, gastrointestinal, or genitourinary tracts. Assuredly abandon STIVARGA in patients with astringent or life-threatening drain and adviser INR levels added frequently in patients accepting warfarin.

Gastrointestinal Breach or Fistula: Gastrointestinal breach occurred in 0.6% of 4518 patients brash with STIVARGA beyond all analytic trials of STIVARGA administered as a distinct agent; this included eight baleful events. Gastrointestinal fistula occurred in 0.8% of patients brash with STIVARGA and in 0.2% of patients in the placebo arm beyond randomized, placebo-controlled trials. Assuredly abandon STIVARGA in patients who advance gastrointestinal breach or fistula.

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Dermatological Toxicity: In randomized, placebo-controlled trials, adverse bark reactions occurred in 71.9% of patients with STIVARGA arm and 25.5% of patients in the placebo arm including hand-foot bark acknowledgment (HFSR) additionally accepted as palmar-plantar erythrodysesthesia affection (PPES) and astringent rash, astute dosage modification. In the randomized, placebo-controlled trials, the all-embracing accident of HFSR was college in 1142 STIVARGA-treated patients (53% vs 8%) than in the placebo-treated patients. Best cases of HFSR in STIVARGA-treated patients appeared during the aboriginal aeon of treatment. The incidences of Brand 3 HFSR (16% vs <1%), Brand 3 adventurous (3% vs <1%), austere adverse reactions of erythema multiforme (<0.1% vs 0%), and Stevens-Johnson affection (<0.1% vs 0%) were college in STIVARGA-treated patients. Beyond all trials, a college accident of HFSR was empiric in Asian patients brash with STIVARGA (all grades: 72%; Brand 3:18%). Baneful epidermal necrolysis occurred in 0.02% of 4518 STIVARGA-treated patients beyond all analytic trials of STIVARGA administered as a distinct agent. Abstain STIVARGA, abate the dose, or assuredly abandon depending on the severity and chain of dermatologic toxicity.

Hypertension: Hypertensive crisis occurred in 0.2% in STIVARGA-treated patients and in none of the patients in placebo arm beyond all randomized, placebo-controlled trials. STIVARGA acquired an added accident of hypertension (30% vs 8% in mCRC, 59% vs 27% in GIST, and 31% vs 6% in HCC). The access of hypertension occurred during the aboriginal aeon of assay in best patients who developed hypertension (67% in randomized, placebo controlled trials). Do not admit STIVARGA until claret burden is abundantly controlled. Adviser claret burden account for the aboriginal 6 weeks of assay and again every cycle, or added frequently, as clinically indicated. Temporarily or assuredly abstain STIVARGA for astringent or amoral hypertension.

Cardiac Ischemia and Infarction: STIVARGA added the accident of myocardial ischemia and infarction (0.9% with STIVARGA vs 0.2% with placebo) in randomized placebo-controlled trials. Abstain STIVARGA in patients who advance new or astute cardiac ischemia or infraction, and resume abandoned afterwards resolution of astute cardiac ischemic contest if the abeyant allowances outweigh the risks of added cardiac ischemia.

Reversible Afterwards Leukoencephalopathy Affection (RPLS): Reversible afterwards leukoencephalopathy affection (RPLS), a affection of subcortial vasogenic edema diagnosed by appropriate award on MRI occurred in one of 4800 STIVARGA-treated patients beyond all analytic trials. Perform an appraisal for RPLS in any accommodating presenting with seizures, astringent headache, beheld disturbances, confusion, or adapted brainy function. Abandon STIVARGA in patients who advance RPLS.

Wound Healing Complications: Assay with STIVARGA should be chock-full at atomic 2 weeks above-mentioned to appointed surgery. Resuming assay afterwards anaplasty should be based on analytic acumen of able anguish healing. STIVARGA should be discontinued in patients with anguish dehiscence.

Embryo-Fetal Toxicity: STIVARGA can account fetal abuse back administered to a abundant woman. There are no accessible abstracts on STIVARGA use in abundant women. Advise abundant women of the abeyant accident to a fetus. Advise females of changeable abeyant and males with changeable ally of changeable abeyant to use able contraception during assay with STIVARGA and for 2 months afterwards the final dose.

Nursing Mothers: Because of the abeyant for austere adverse reactions in fed breed from STIVARGA, do not feed during assay with STIVARGA and for 2 weeks afterwards the final dose.

Most Frequently Empiric Adverse Biologic Reactions in mCRC (≥30%): The best frequently empiric adverse biologic reactions (≥30%) in STIVARGA-treated patients vs placebo-treated patients in mCRC, respectively, were: asthenia/fatigue (64% vs 46%), affliction (59% vs 48%), decreased appetence and aliment assimilation (47% vs 28%), HFSR/PPE (45% vs 7%), diarrhea (43% vs 17%), mucositis (33% vs 5%), weight accident (32% vs 10%), infection (31% vs 17%), hypertension (30% vs 8%), and dysphonia (30% vs 6%).

Most Frequently Empiric Adverse Biologic Reactions in GIST (≥30%): The best frequently empiric adverse biologic reactions (≥30%) in STIVARGA-treated patients vs placebo-treated patients in GIST, respectively, were: HFSR/PPE (67% vs 12%), affliction (60% vs 55%), 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 appetence and aliment assimilation (31% vs 21%), and adventurous (30% vs 3%).

Most Frequently Empiric Adverse Biologic Reactions in HCC (≥30%): The best frequently empiric adverse biologic reactions (≥30%) in STIVARGA-treated patients vs placebo-treated patients in HCC, respectively, were: affliction (55% vs 44%), HFSR/PPE (51% vs 7%), asthenia/fatigue (42% vs 33%), diarrhea (41% vs 15%), hypertension (31% vs 6%), infection (31% vs 18%), decreased appetence and aliment assimilation (31% vs 15%).

Please see abounding Prescribing Information, including Boxed Warning for Stivarga (regorafenib).

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About NEXAVAR® (sorafenib) Tablets3NEXAVAR is accustomed in the U.S. for the assay of patients with unresectable hepatocellular carcinoma, patients with avant-garde renal corpuscle blight and patients with locally alternate or metastatic, progressive, differentiated thyroid blight adverse to radioactive iodine treatment.

Important Assurance Advice for Nexavar

Please see abounding Prescribing Advice for Nexavar (sorafenib).

About Larotrectinib (LOXO-101)Larotrectinib is an investigational tropomyosin receptor kinase (TRK) inhibitor in analytic development for the assay of patients with cancers that anchorage a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. Growing assay suggests that the NTRK genes can become abnormally alloyed to added genes, bearing a TRK admixture protein that can advance to the development of solid tumors beyond assorted altered blight bump tissues.

In November 2017, Bayer and Loxo Oncology entered into an absolute all-around accord for the development and commercialization of larotrectinib and LOXO-195, a TRK inhibitor in analytic development. Bayer and Loxo Oncology will accordingly advance the two articles with Loxo Oncology arch the advancing analytic studies as able-bodied as the filing in the U.S., and Bayer arch ex-U.S. authoritative activities and accepted bartering activities. In the U.S., Bayer and Loxo Oncology will co-promote the products.

For added advice about the larotrectinib analytic trials, amuse accredit to www.clinicaltrials.gov or visit www.loxooncologytrials.com. Larotrectinib has not been accustomed by the U.S. Aliment and Biologic Administration, the European Medicines Agency or any added bloom authority.

About AliqopaTM (copanlisib) Injection4Aliqopa is a PI3K inhibitor with absolute activity adjoin the PI3K-alpha and PI3K-delta isoforms bidding in cancerous B-cells, developed by Bayer. Aliqopa is adumbrated in the U.S. for the assay of developed patients with relapsed follicular lymphoma (FL) who accept accustomed at atomic two above-mentioned systemic therapies.

Accelerated approval was accepted for this adumbration based on all-embracing acknowledgment rate. Continued approval for this adumbration may be accidental aloft analysis and description of analytic account in a acknowledging trial. Aliqopa has been apparent to abet bump corpuscle afterlife by apoptosis and inhibition of admeasurement of primary cancerous B corpuscle lines. Aliqopa inhibits several key cell-signaling pathways, including B-cell receptor signaling, CXCR12 advised chemotaxis of cancerous B cells, and NFκB signaling in lymphoma corpuscle lines.

The ample analytic development affairs for copanlisib additionally includes advancing Phase III studies in blah NHL (iNHL) patients who accept relapsed or are adverse to above-mentioned therapies. The CHRONOS-3 Phase III abstraction is evaluating copanlisib in aggregate with rituximab in relapsed iNHL and the CHRONOS-4 Phase III abstraction is evaluating copanlisib in aggregate with accepted immunochemotherapy in relapsed iNHL. Added advice about these trials can be begin at www.clinicaltrials.gov.

Important Assurance Advice for AliqopaInfections: Serious, including fatal, infections occurred in 19% of 317 patients brash with ALIQOPA monotherapy. The best accepted austere infection was pneumonia. Adviser patients for signs and affection of infection and abstain ALIQOPA for Brand 3 and college infection.

Serious pneumocystis jiroveci pneumonia (PJP) infection occurred in 0.6% of 317 patients brash with ALIQOPA monotherapy. Afore initiating assay with ALIQOPA, accede PJP prophylaxis for populations at risk.  Abstain ALIQOPA in patients with doubtable PJP infection of any grade. If confirmed, amusement infection until resolution, again resume ALIQOPA at antecedent dosage with accessory PJP prophylaxis.

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Hyperglycemia: Brand 3 or 4 hyperglycemia (blood glucose 250 mg/dL or greater) occurred in 41% of 317 patients brash with ALIQOPA monotherapy. Austere hyperglycemic contest occurred in 2.8% of patients. Assay with ALIQOPA may aftereffect in infusion-related hyperglycemia. Claret glucose levels about ailing 5 to 8 hours post-infusion and afterwards beneath to baseline levels for a majority of patients; claret glucose levels remained animated in 17.7% of patients one day afterwards ALIQOPA infusion. Of 155 patients with baseline HbA1c <5.7%, 16 (10%) patients had HbA1c >6.5% at the end of treatment.

Of the twenty patients with diabetes mellitus brash in CHRONOS-1, seven developed Brand 4 hyperglycemia and two discontinued treatment. Patients with diabetes mellitus should abandoned be brash with ALIQOPA afterward able glucose ascendancy and should be monitored closely. Withhold, abate dose, or abandon ALIQOPA depending on the severity and chain of hyperglycemia.

Achieve optimal claret glucose ascendancy afore starting anniversary ALIQOPA infusion. Withhold, abate dose, or abandon ALIQOPA depending on the severity and chain of hyperglycemia.

Hypertension: Brand 3 hypertension (systolic 160 mmHg or greater or diastolic 100 mmHg or greater) occurred in 26% of 317 patients brash with ALIQOPA monotherapy. Austere hypertensive contest occurred in 0.9% of 317 patients. Assay with ALIQOPA may aftereffect in infusion-related hypertension. The beggarly change of systolic and diastolic BP from baseline to 2 hours post-infusion on Aeon 1 Day 1 was 16.8 mmHg and 7.8 mmHg, respectively. The beggarly BP started abbreviating about 2 hours post-infusion; BP remained animated for 6 to 8 hours afterwards the alpha of the ALIQOPA infusion. Optimal BP ascendancy should be accomplished afore starting anniversary ALIQOPA infusion. Adviser BP pre- and post-infusion. Withhold, abate dose, or abandon ALIQOPA depending on the severity and chain of hypertension.

Non-infectious Pneumonitis: Non-infectious pneumonitis occurred in 5% of 317 patients brash with ALIQOPA monotherapy. Abstain ALIQOPA and conduct a analytic assay of a accommodating who is experiencing pulmonary affection such as cough, dyspnea, hypoxia, or interstitial infiltrates on radiologic exam. Patients with pneumonitis anticipation to be acquired by ALIQOPA accept been managed by denial ALIQOPA and administering of systemic corticosteroids. Withhold, abate dose, or abandon ALIQOPA depending on the severity and chain of non-infectious pneumonitis.

Neutropenia: Brand 3 or 4 neutropenia occurred in 24% of 317 patients brash with ALIQOPA monotherapy. Austere neutropenic contest occurred in 1.3%. Adviser claret counts at atomic account during assay with ALIQOPA. Withhold, abate dose, or abandon ALIQOPA depending on the severity and chain of neutropenia.

Severe Cutaneous Reaction: Brand 3 and 4 cutaneous reactions occurred in 2.8% and 0.6% of 317 patients brash with ALIQOPA monotherapy respectively. Austere cutaneous acknowledgment contest were appear in 0.9%. The appear contest included dermatitis exfoliative, exfoliative rash, pruritus, and adventurous (including maculo-papular rash). Withhold, abate dose, or abandon ALIQOPA depending on the severity and chain of astringent cutaneous reactions.

Embryo-Fetal Toxicity: Based on allegation in animals and its apparatus of action, ALIQOPA can account fetal abuse back administered to a abundant woman. In beastly reproduction studies, administering of copanlisib to abundant rats during organogenesis acquired embryo-fetal afterlife and fetal abnormalities in rats at affectionate doses as low as 0.75 mg/kg/day (4.5 mg/m2/day anatomy apparent area) agnate to about 12% the recommended dosage for patients. Advise abundant women of the abeyant accident to a fetus. Advise females of changeable abeyant and males with changeable ally of changeable abeyant to use able contraception during assay and for at atomic one ages afterwards the aftermost dose.

Adverse Biologic Reactions: Austere adverse reactions were appear in 44 (26%) patients. The best common austere adverse reactions that occurred were pneumonia (8%), pneumonitis (5%) and hyperglycemia (5%). Adverse reactions resulted in dosage abridgement in 36 (21%) and cessation in 27 (16%) patients. The best frequently empiric adverse biologic reactions (≥20%) in ALIQOPA-treated patients were: hyperglycemia (54%), leukopenia (36%), diarrhea (36%), decreased accepted backbone and activity (36%), hypertension (35%), neutropenia (32%), abhorrence (26%), thrombocytopenia (22%), and lower respiratory amplitude infections (21%).

Drug Interactions: Abstain accessory use with able CYP3A inducers. Abate the ALIQOPA dosage to 45 mg back accordingly administered with able CYP3A inhibitors.

Lactation: Advise women not to feed. Advise a lactating woman not to feed during assay with ALIQOPA and for at atomic 1 ages afterwards the aftermost dose.

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Please see the abounding Prescribing Advice for Aliqopa (copanlisib).

About Oncology at BayerBayer is committed to carrying science for a bigger activity by advancing a portfolio of avant-garde treatments. The oncology authorization at Bayer now includes four oncology articles and several added compounds in assorted stages of analytic development. Together, these articles reflect the company’s access to research, which prioritizes targets and pathways with the abeyant to appulse the way that blight is treated.

About BayerBayer is a all-around action with amount competencies in the Activity Science fields of bloom affliction and agriculture. Its articles and casework are advised to account bodies and advance their affection of life. At the aforementioned time, the Accumulation aims to actualize amount through innovation, advance and aerial earning power. Bayer is committed to the attempt of acceptable development and to its amusing and ethical responsibilities as a accumulated citizen. In budgetary 2017, the Accumulation active about 99,800 bodies and had sales of EUR 35.0 billion. Capital expenditures amounted to EUR 2.4 billion, R&D costs to EUR 4.5 billion. For added information, go to www.bayer.us.

© 2018 Bayer BAYER®, the Bayer Cross, Xofigo, Stivarga, Nexavar and Aliqopa are registered trademarks of Bayer.

Media Contact: Rose Talarico, Tel. 1 862.404.5302E-Mail: [email protected]

Forward-Looking StatementsThis account absolution may accommodate advanced statements based on accepted assumptions and forecasts fabricated by Bayer Accumulation or subgroup management. Assorted accepted and alien risks, uncertainties and added factors could advance to absolute differences amid the absolute approaching results, banking situation, development or achievement of the aggregation and the estimates accustomed here. These factors accommodate those discussed in Bayer’s accessible letters which are accessible on the Bayer website at www.bayer.com. The aggregation assumes no accountability whatsoever to amend these advanced statements or to accommodate them to approaching contest or developments. 

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