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1 [Presenter First Name] [Presenter Title] [Presenter Institution] Lenvatinib + everolimus Clinical Information for the Treatment of Advanced Renal Cell Carcinoma
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2 Please Note This promotional presentation is sponsored by Eisai Inc. The speaker is presenting the information contained herein on behalf of Eisai Inc. and the information being presented by the speaker is consistent with FDA Guidelines. If there are questions that the speaker is unable to answer: Please contact Eisai’s Medical Information Department at 1-888-274-2378 for more information, or See the Eisai representative who will document the request to be sent to Eisai’s Medical Information Department for follow-up
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3 Indication LENVIMA ® (lenvatinib) is indicated in combination with everolimus for the treatment of patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy. Please see Important Safety Information throughout and available full Prescribing Information.
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4 Study 205 A multicenter, randomized, phase 2 trial in patients with advanced or metastatic RCC who had previously received anti-angiogenic therapy 1 a Patients were stratified by hemoglobin level (≤13 g/dL vs >13 g/dL for males and ≤11.5 g/dL vs >11.5 g/dL for females) and corrected serum calcium (≥10 mg/dL vs <10 mg/dL). b Investigator-assessed and evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
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5 Study 205 (cont’d) Key inclusion criteria 1 Patients were required to have histological confirmation of clear cell RCC Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 Baseline patient demographics 1 Of the 101 patients randomly allocated to the LENVIMA + everolimus arm and everolimus monotherapy arm 72% were male; the median age was 60 years; 31% were older than 65 years; 96% were white metastases were present in 95%, and unresectable advanced disease was present in 5% all patients had a baseline ECOG PS of either 0 (54%) or 1 (46%), with similar distribution across the 2 treatment arms Memorial Sloan Kettering Cancer Center (MSKCC) favorable, intermediate, and poor risk categories were observed in 24%, 37%, and 39% of patients in the LENVIMA + everolimus arm and 24%, 38%, and 38% of patients in the everolimus arm, respectively
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6 Efficacy Outcomes in Study 205 Major efficacy outcome measure: progression-free survival (PFS) 1 CI=confidence interval; HR=hazard ratio.
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7 Efficacy Outcomes in Study 205 (cont’d) Median PFS 1 14.6 months (95% CI: 5.9-20.1) with LENVIMA + everolimus vs 5.5 months (95% CI: 3.5-7.1) with everolimus alone (HR [95% CI]: 0.37 [0.22-0.62]) 26 events (51%) occurred in the LENVIMA + everolimus arm vs 37 events (74%) in the everolimus arm – 21 patients (41%) who received LENVIMA + everolimus progressed vs 35 patients (70%) who received everolimus – Death occurred in 5 patients (10%) who received LENVIMA + everolimus vs 2 patients (4%) who received everolimus The treatment effect of LENVIMA + everolimus on PFS was supported by a retrospective, independent review of radiographs with an observed HR of 0.43 (95% CI: 0.24-0.75) compared with the everolimus arm
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8 Efficacy Outcomes in Study 205 (cont’d) Other efficacy outcome measure: confirmed objective response rate (ORR) 1 37% confirmed ORR (95% CI: 24%-52%) with LENVIMA + everolimus vs 6% with everolimus (95% CI: 1%-17%) – 2% of patients in the LENVIMA + everolimus arm achieved a complete response (CR) vs 0 patients in the everolimus arm – 35% of patients in the LENVIMA + everolimus arm achieved a partial response (PR) vs 6% of patients in the everolimus arm Response criteria Tumor assessments were evaluated according to RECIST 1.1 1,2 – CR: no detectable evidence of tumors following treatment – PR: ≥30% reduction in tumor size following treatment Objective responses were confirmed according to RECIST 1.1 (≥4 weeks following initial response) 3 – In Study 205, all objective responses were confirmed at the next scheduled assessment 8 weeks later
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9 Other efficacy outcome measure: overall survival (OS) 1 Median OS 1 25.5 months (95% CI: 16.4-32.1) with LENVIMA + everolimus vs 15.4 months (95% CI: 11.8-20.6) with everolimus alone (HR [95% CI]: 0.67 [0.42-1.08])* Efficacy Outcomes in Study 205 (cont’d) *Analysis was conducted after 63% of deaths had occurred in the LENVIMA + everolimus arm and 74% of deaths had occurred in the everolimus arm.
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10 Important Safety Information Warnings and Precautions Hypertension was reported in 42% of patients on LENVIMA + everolimus vs 10% with everolimus alone (13% vs 2% grade 3). Blood pressure should be controlled prior to treatment and monitored throughout. Withhold dose for grade 3 hypertension despite optimal antihypertensive therapy; resume at reduced dose when controlled at grade ≤2. Discontinue for life-threatening hypertension Cardiac dysfunction was reported in 10% of patients on LENVIMA + everolimus vs 6% with everolimus alone (3% vs 2% grade 3). Monitor for signs/symptoms of cardiac decompensation. Withhold for grade 3 cardiac dysfunction. Resume at reduced dose or discontinue based on severity and persistence of cardiac dysfunction. Discontinue for grade 4 cardiac dysfunction Arterial thromboembolic events were reported in 2% of patients on LENVIMA + everolimus vs 6% with everolimus alone (2% vs 4% grade ≥3). Discontinue following an arterial thrombotic event. The safety of resuming LENVIMA after an arterial thromboembolic event has not been established, and LENVIMA has not been studied in patients who have had an arterial thromboembolic event within the previous 6 months
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11 Important Safety Information (cont’d) Across clinical studies in which 1,160 patients received LENVIMA monotherapy, hepatic failure (including fatal events) was reported in 3 patients and acute hepatitis in 1 patient. ALT and AST increases (grade ≥3) occurred in 3% of patients on LENVIMA + everolimus vs 2% and 0% with everolimus alone, respectively. Monitor liver function before initiation, then every 2 weeks for the first 2 months, and at least monthly thereafter during treatment. Withhold dose for liver impairment grade ≥3 until resolved to grade 0, 1, or baseline. Resume at reduced dose or discontinue based on severity/persistence of hepatotoxicity. Discontinue for hepatic failure Proteinuria was reported in 31% of patients on LENVIMA + everolimus vs 14% with everolimus alone (8% vs 2% grade 3). Monitor for proteinuria before and during treatment. Withhold dose for proteinuria ≥2 g/24 h. Resume at reduced dose when proteinuria is <2 g/24 h. Discontinue for nephrotic syndrome Diarrhea was reported in 81% of patients on LENVIMA + everolimus vs 34% with everolimus alone (19% vs 2% grade ≥3). Initiate prompt medical management for the development of diarrhea. Monitor for dehydration. Withhold dose for diarrhea grade ≥3. Resume at a reduced dose when diarrhea resolves to grade 1 or baseline. Discontinue for grade 4 diarrhea despite medical management
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12 Important Safety Information (cont’d) Events of renal impairment were reported in 18% of patients on LENVIMA + everolimus vs 12% with everolimus alone (10% vs 2% grade ≥3). Withhold LENVIMA for grade 3 or 4 renal failure/impairment. Resume at reduced dose or discontinue, depending on severity/persistence of renal impairment. Active management of diarrhea and any other gastrointestinal (GI) symptoms should be initiated for grade 1 events Events of GI perforation, abscess, or fistula (grade ≥3) were reported in 2% of patients on LENVIMA + everolimus vs 0% with everolimus alone. Discontinue in patients who develop GI perforation or life-threatening fistula QTc interval increases >60 ms were reported in 11% of patients on LENVIMA + everolimus (6% >500 ms) vs 0% with everolimus alone. Monitor electrocardiograms in patients with congenital long QT syndrome, congestive heart failure, bradyarrhythmias, or patients taking drugs known to prolong the QT interval. Monitor and correct electrolyte abnormalities in all patients. Withhold dose for QTc interval prolongation >500 ms. Resume at reduced dose when QTc prolongation resolves to baseline Hypocalcemia (grade ≥3) was reported in 6% of patients on LENVIMA + everolimus vs 2% with everolimus alone. Monitor blood calcium levels at least monthly and replace calcium as necessary. Interrupt and adjust LENVIMA as necessary
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13 Important Safety Information (cont’d) Across clinical studies in which 1,160 patients received LENVIMA monotherapy, reversible posterior leukoencephalopathy syndrome (RPLS) was reported in 4 patients. Withhold LENVIMA for RPLS until fully resolved. Resume at reduced dose or discontinue based on the severity and persistence of neurologic symptoms Hemorrhagic events occurred in 34% of patients on LENVIMA + everolimus vs 26% with everolimus alone (8% vs 2% grade ≥3). The most frequently reported hemorrhagic event was epistaxis (23% for LENVIMA + everolimus vs 24% with everolimus alone). There was 1 fatal cerebral hemorrhage case. Discontinuation due to hemorrhagic events occurred in 3% of patients on LENVIMA + everolimus. Consider the risk of severe or fatal hemorrhage associated with tumor invasion/infiltration of major blood vessels (eg, carotid artery). Withhold dose for grade 3 hemorrhage. Resume at reduced dose or discontinue based on severity/persistence of hemorrhage. Discontinue for grade 4 hemorrhage Grade 1 or 2 hypothyroidism occurred in 24% of patients on LENVIMA + everolimus vs 2% with everolimus alone. In patients with normal or low thyroid-stimulating hormone (TSH) at baseline, elevation of TSH was observed postbaseline in 60% of patients on LENVIMA + everolimus vs 3% with everolimus alone. Monitor thyroid function prior to treatment initiation and monthly thereafter. Treat hypothyroidism according to standard medical practice to maintain a euthyroid state LENVIMA can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with LENVIMA and for at least 2 weeks following completion of therapy
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14 Important Safety Information (cont’d) Adverse Reactions The most common adverse reactions observed in patients treated with LENVIMA + everolimus vs everolimus alone were diarrhea (81% vs 34%), fatigue (73% vs 40%), arthralgia/myalgia (55% vs 32%), decreased appetite (53% vs 18%), vomiting (48% vs 12%), nausea (45% vs 16%), stomatitis/oral inflammation (44% vs 50%), hypertension/ increased blood pressure (42% vs 10%), peripheral edema (42% vs 20%), cough (37% vs 30%), abdominal pain (37% vs 8%), dyspnea/exertional dyspnea (35% vs 28%), rash (35% vs 40%), weight decreased (34% vs 8%), hemorrhagic events (32% vs 26%), and proteinuria/urine protein present (31% vs 14%) Adverse reactions led to dose reductions or interruption in 89% of patients receiving LENVIMA + everolimus and in 54% of patients receiving everolimus. The most common adverse reactions (≥5%) resulting in dose reductions in the LENVIMA + everolimus–treated group were diarrhea (21%), fatigue (8%), thrombocytopenia (6%), vomiting (6%), nausea (5%), and proteinuria (5%). Treatment discontinuation due to an adverse reaction occurred in 29% of patients in the LENVIMA + everolimus–treated group and in 12% of patients in the everolimus-treated group
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15 Important Safety Information (cont’d) Use in Specific Populations Because of the potential for serious adverse reactions in nursing infants, advise women to discontinue breastfeeding during treatment LENVIMA may result in reduced fertility in females of reproductive potential and may result in damage to male reproductive tissues, leading to reduced fertility of unknown duration
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16 Adverse Reactions* Grades 1-4 adverse reactions in >15% of patients in the LENVIMA ® + everolimus arm 1 a Includes abdominal discomfort, gastrointestinal pain, lower abdominal pain, and upper abdominal pain. b Includes gingival pain, glossodynia, and oropharyngeal pain. c Includes aphthous stomatitis, gingival inflammation, glossitis, and mouth ulceration. LENVIMA 18 mg + everolimus 5 mg (n=62) Everolimus 10 mg (n=50) System organ class preferred termGrades 1-4 (%)Grades 3-4 (%)Grades 1-4 (%)Grades 3-4 (%) Endocrine disorders Hypothyroidism24020 Gastrointestinal disorders Constipation 16 018 0 Diarrhea 81 1934 2 Dyspepsia/gastro esophageal reflux 21 012 0 Abdominal pain a 37 38 0 Nausea 45 516 0 Oral pain b 23 24 0 Stomatitis/oral inflammation c 44 250 4 Vomiting487120 * The safety data are derived from Study 205 and an additional 11 patients in the dose escalation portion of the study who received LENVIMA 18 mg + everolimus 5 mg.
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17 Adverse Reactions* (cont’d) Grades 1-4 adverse reactions in >15% of patients in the LENVIMA ® + everolimus arm 1 d Includes asthenia, fatigue, lethargy and malaise. e Includes arthralgia, back pain, extremity pain, musculoskeletal pain, and myalgia. LENVIMA 18 mg + everolimus 5 mg (n=62) Everolimus 10 mg (n=50) System organ class preferred termGrades 1-4 (%)Grades 3-4 (%)Grades 1-4 (%)Grades 3-4 (%) General disorders and administration site conditions Fatigue d 731840 2 Peripheral edema42220 0 Pyrexia/increased body temperature21210 2 Investigations Weight decreased 34 38 0 Metabolism and nutrition disorders Decreased appetite 53 518 0 Musculoskeletal and connective tissue disorders Arthralgia/myalgia e 55 532 0 Musculoskeletal chest pain 18 24 0 Nervous system disorders Headache19 210 2 * The safety data are derived from Study 205 and an additional 11 patients in the dose escalation portion of the study who received LENVIMA 18 mg + everolimus 5 mg.
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18 Adverse Reactions* (cont’d) Grades 1-4 adverse reactions in >15% of patients in the LENVIMA ® + everolimus arm 1 LENVIMA 18 mg + everolimus 5 mg (n=62) Everolimus 10 mg (n=50) System organ class preferred termGrades 1-4 (%)Grades 3-4 (%)Grades 1-4 (%)Grades 3-4 (%) Psychiatric disorders Insomnia1622 0 Renal and urinary disorders Proteinuria/urine protein present31814 2 Renal failure event f 181012 2 Respiratory, thoracic and mediastinal disorders Cough37030 0 Dysphonia1804 0 Dyspnea/exertional dyspnea35528 8 Skin and subcutaneous tissue disorders Rash g 35040 0 Vascular disorders Hemorrhagic events h 32626 2 Hypertension/increased blood pressure4213102 f Includes blood creatinine increased, blood urea increased, creatinine renal clearance decreased, nephropathy toxic, renal failure, renal failure acute, and renal impairment. g Includes erythema, erythematous rash, genital rash, macular rash, maculopapular rash, papular rash, pruritic rash, pustular rash, and septic rash. h Includes hemorrhagic diarrhea, epistaxis, gastric hemorrhage, hemarthrosis, hematoma, hematuria, hemoptysis, lip hemorrhage, renal hematoma, and scrotal hematocele. * The safety data are derived from Study 205 and an additional 11 patients in the dose escalation portion of the study who received LENVIMA 18 mg + everolimus 5 mg.
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19 Grade 3-4 laboratory abnormalities in ≥3% of patients in the LENVIMA + everolimus arm 1,a,b LENVIMA 18 mg + everolimus 5 mg (n=62) Everolimus 10 mg (n=50) Laboratory abnormalityGrades 3-4 (%) Chemistry Aspartate aminotransferase (AST) increased30 Alanine aminotransferase (ALT) increased32 Alkaline phosphatase increased30 Hyperkalemia62 Hypokalemia62 Hyponatremia116 Hypocalcemia62 Hypophosphatemia116 Hyperglycemia316 Hypertriglyceridemia18 Elevated cholesterol110 Creatine kinase increased34 Lipase increased1312 Adverse Reactions* (cont’d) a With at least 1 grade increase from baseline. b Subject with at least 1 postbaseline laboratory value. * The safety data are derived from Study 205 and an additional 11 patients in the dose escalation portion of the study who received LENVIMA 18 mg + everolimus 5 mg.
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20 Grade 3-4 laboratory abnormalities in ≥3% of patients in the LENVIMA + everolimus arm 1,a,b LENVIMA 18 mg + everolimus 5 mg (n=62) Everolimus 10 mg (n=50) Laboratory abnormalityGrades 3-4 (%) Hematology Hemoglobin decreased 8 16 Platelet count decreased 5 0 Lymphocyte count decreased1020 Adverse Reactions* (cont’d) a With at least 1 grade increase from baseline. b Subject with at least 1 postbaseline laboratory value. The median treatment duration was 8.1 months for LENVIMA + everolimus and 4.1 months for everolimus 1 * The safety data are derived from Study 205 and an additional 11 patients in the dose escalation portion of the study who received LENVIMA 18 mg + everolimus 5 mg.
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21 Dosing and Administration Recommended combination dose 1 LENVIMA is available as 10-mg and 4-mg capsules
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22 Dosing and Administration (cont’d) The recommended daily dose of LENVIMA is 18 mg (one 10-mg capsule and two 4-mg capsules) in combination with 5 mg everolimus taken orally once a day, with or without food – Continue LENVIMA + everolimus until disease progression or until unacceptable toxicity The LENVIMA + everolimus combination dose should be taken at the same time each day. If a patient misses a dose, and it cannot be taken within 12 hours, then that dose should be skipped, and the next dose should be taken at the usual time of administration For patients who have trouble swallowing the capsules whole, the capsules can be dissolved in a small glass of liquid. Patients should measure 1 tablespoon of water or apple juice and put the capsules into the liquid without breaking or crushing them. The capsules should be left in the liquid for at least 10 minutes. Patients should stir for at least 3 minutes, then they may drink the mixture. After drinking, patients should add the same amount (1 tablespoon) of water or apple juice to the glass and swirl the contents a few times before swallowing the additional liquid
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23 Dosing and Administration (cont’d) How supplied LENVIMA capsules are supplied in cartons of 6 blister cards. Each carton contains a 30-day supply of LENVIMA capsules 1 Everolimus is manufactured and supplied by Novartis Pharmaceuticals Corporation
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24 Adverse Reaction Management a Grade 3 despite optimal antihypertensive therapy. Adverse reactions requiring dose modification of LENVIMA ®1 Adverse reactionCTCAE gradeActionDose reduce and resume LENVIMA Hypertension Grade 3 a HoldResolves to grade 0-2 Grade 4DiscontinueDo not resume Cardiac dysfunction Grade 3HoldResolves to grade 0-1, or baseline Grade 4DiscontinueDo not resume Arterial thrombotic eventAny gradeDiscontinueDo not resume HepatotoxicityGrade 3 or 4Hold OR Discontinue Consider resuming at reduced dose if resolves to grade 0-1 or baseline Hepatic FailureGrade 3 or 4DiscontinueDo not resume Proteinuria≥2 gm/24 hoursHoldResolves to <2 gm/24 hours Nephrotic syndrome — DiscontinueDo not resume
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25 Adverse Reaction Management (cont’d) Adverse reactions requiring dose modification of LENVIMA ®1 Adverse reactionCTCAE gradeActionDose reduce and resume LENVIMA Nausea, vomiting, and diarrhea b Grade 3HoldResolves to grade 0-1 or baseline Vomiting and diarrhea b Grade 4DiscontinueDo not resume Renal failure or impairmentGrade 3 or 4Hold OR discontinue Consider resuming at reduced dose if resolves to grade 0-1 or baseline GI perforationAny gradeDiscontinueDo not resume FistulaGrade 3 or 4DiscontinueDo not resume QTc prolongation>500 msHoldResolves to <480 ms or baseline RPLSAny gradeHold OR discontinue Consider resuming at reduced dose if resolves to grade 0-1 Hemorrhage Grade 3HoldResolves to grade 0-1 Grade 4DiscontinueDo not resume b Initiate prompt medical management for nausea, vomiting, or diarrhea. Permanently discontinue for grade 4 vomiting and diarrhea despite medical management.
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26 Adverse Reaction Management (cont’d) Manage other adverse reactions according to the instructions in the table below. Dose modifications of LENVIMA ® for persistent and intolerable grade 2 or grade 3 adverse reactions or grade 4 laboratory abnormalities 1,a Adverse reactionModificationAdjusted dose b First occurrence Interrupt until resolved to grade 0-1 or baseline 14 mg (one 10-mg capsule plus one 4-mg capsule) orally once daily Second occurrence c Interrupt until resolved to grade 0-1 or baseline 10 mg (one 10-mg capsule) orally once daily Third occurrence c Interrupt until resolved to grade 0-1 or baseline 8 mg (two 4-mg capsules) orally once daily a Initiate medical management for nausea, vomiting, or diarrhea prior to interruption or dose reduction of LENVIMA. b Reduce dose in succession based on the previous dose level (18 mg, 14 mg, 10 mg, or 8 mg per day). c Refers to the same or a different adverse reaction that requires dose modification.
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27 Adverse Reaction Management (cont’d) Recommended dose of LENVIMA ® for renal or hepatic impairment 1 In patients withRecommended dose Severe renal impairment (CrCl <30 mL/min) a 10 mg (one 10-mg capsule) once daily Severe hepatic impairment (Child-Pugh C)10 mg (one 10-mg capsule) once daily CrCl=creatinine clearance. a As calculated by the Cockcroft-Gault equation. No dose adjustment is recommended in patients with mild or moderate renal or hepatic impairment. Patients with end-stage renal disease were not studied.
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28 Adverse Reaction Management (cont’d) Recommendations for dose modification of everolimus 1 Review the full Prescribing Information for everolimus for recommended dose modifications. For toxicities thought to be related to everolimus alone, discontinue, interrupt, or use alternate-day dosing. For toxicities thought to be related to both LENVIMA and everolimus, first reduce LENVIMA and then everolimus.
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29 Mechanism of Action Combining the tyrosine kinase inhibition of LENVIMA ® and the mTOR inhibition of everolimus 1,4 LENVIMA inhibits the kinase activities of VEGF receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA also inhibits other receptor tyrosine kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression, in addition to their normal cellular functions, including FGF receptors FGFR1, 2, 3, and 4 PDGFRα KIT RET The combination of LENVIMA and everolimus showed increased anti-angiogenic and antitumor activity as demonstrated by decreased human endothelial cell proliferation, tube formation, and VEGF signaling in vitro and tumor volume in mouse xenograft models of human RCC greater than with each drug alone. mTOR=mammalian target of rapamycin; VEGF=vascular endothelial growth factor; VEGFR=vascular endothelial growth factor receptor; FGF=fibroblast growth factor; FGFR=fibroblast growth factor receptor; PDGFRα=platelet-derived growth factor receptor alpha; MOA=mechanism of action.
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30 LENVIMA ® access and reimbursement information Accessing LENVIMA through Specialty Pharmacy LENVIMA is available through 2 Specialty Pharmacies—Accredo and Biologics—that will mail the prescription directly to your patient and will provide a number of services, including an independent care team to provide live patient support and clinical counseling a patient starter kit that includes key LENVIMA educational materials and helpful resources for patients receiving therapy ongoing patient communications for monitoring patient progress, adverse reaction management, and questions about LENVIMA therapy comprehensive benefit investigation to help patients understand their coverage for LENVIMA LENVIMA $0 co-pay and financial support The LENVIMA $0 Co-pay Program offers commercially insured patients a $0 co-pay on each prescription, with a $40,000 annual limit.* No activation is required. Eisai Assistance Program The Eisai Assistance Program is designed to help facilitate access and reimbursement support for you and your patients. Benefits include insurance verification and information about coverage and financial assistance programs. *Maximum benefit: The LENVIMA $0 Co-pay Program provides up to $40,000 per year to assist with the out-of-pocket costs for LENVIMA.
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31 LENVIMA ® access and reimbursement information (cont’d) Eisai cannot guarantee payment of any claim. Coding, coverage, and reimbursement may vary significantly by payer, plan, patient, and setting of care. Actual coverage and reimbursement decisions are made by individual payers following the receipt of claims. For additional information, customers should consult with their payers for all relevant coding, reimbursement, and coverage requirements. It is the sole responsibility of the provider to select the proper code and ensure the accuracy of all claims used in seeking reimbursement. All services must be medically appropriate and properly supported in the patient medical record. Depending on the insurance plan, your patient could have additional financial responsibility for any amounts over Eisai’s maximum liability. Eligibility criteria: Good toward the purchase of LENVIMA prescriptions. No substitutions permitted. Not available to patients eligible for state or federal healthcare programs, including Medicare, Medicaid, Medigap, VA, DoD, or TRICARE. Offer only available to patients with private, commercial insurance. Offer available to MA residents through June 30, 2017. May not be combined with any other coupon, discount, prescription savings card, free trial, or other offer. Eisai Inc. reserves the right to rescind, revoke, or amend this offer at any time without notice. Patients and pharmacies are responsible for disclosing to insurance carriers the redemption and value of the program and complying with any other conditions imposed by insurance carriers on third-party payers. The value of this program is not contingent on any prior or future purchases. This program is solely intended to provide savings on a purchase of LENVIMA. Use of this program for any one purchase does not obligate the patient to make future purchases of LENVIMA or any other product. This offer will expire March 31, 2020.
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32 References 1. LENVIMA [package insert]. Woodcliff Lake, NJ: Eisai Inc.; 2016. 2. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228-247. 3. Data on file, Eisai Inc. 4. AFINITOR [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2016.
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Thank You LENVIMA ® is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd. © 2016 Eisai Inc. All rights reserved. July 2016 LENV-US0374(1) Please see Important Safety Information throughout and full Prescribing Information.
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