New Data on Several Oncology Compounds at ASCO 2015

WOODCLIFF LAKE, N.J., May 14, 2015 -- Eisai Inc. announced today the presentation of seven abstracts at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) highlighting the breadth of the company's oncology portfolio. The meeting will be held May 29-June 2 in Chicago.
"We are excited by our data at this year's ASCO Annual Meeting, which exemplify the strength and diversity of Eisai's oncology portfolio and our ongoing dedication to providing potential treatment options to underserved patient populations," said Kenichi Nomoto, Ph.D., President, Oncology Product Creation Unit at Eisai Inc. "In support of our human health care (hhc) mission, we remain committed to the development of compounds that have the potential to positively affect the lives of patients with cancer and thereby their loved ones."
Of note, the results of a Phase 3 study of eribulin mesylate for investigational use in advanced soft tissue sarcoma (STS) will be included in the ASCO press conference on Saturday, May 30. The data will also be presented in an oral session on June 1.
In addition, the results of a Phase 2 study of lenvatinib for investigational use in metastatic renal cell carcinoma will be presented in an oral session on June 1.
Additional presentations will include ongoing analyses of the Phase 3 trial evaluating lenvatinib, a receptor tyrosine kinase (RTK) inhibitor, in radioactive iodine-refractory differentiated thyroid cancer; palonosetron in the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric patients; and NEPA, an oral fixed combination of netupitant and palonosetron, in the prevention of CINV in patients receiving carboplatin chemotherapy.
The following abstracts are accepted for presentation at this year's ASCO meeting:
Abstract Name
Session
Eribulin Mesylate Abstracts
Randomized, open-label, multicenter, phase 3 study of eribulin versus dacarbazine in patients (pts) with leiomyosarcoma (LMS) and adipocytic sarcoma (ADI)
Abstract #LBA10502
Oral presentation
Monday, June 1
Oral: 3:48 p.m. - 4:00 p.m. CT
Schöffski P.
Lenvatinib Abstracts
Randomized phase II three-arm trial of lenvatinib (LEN), everolimus (EVE), and LEN+EVE in patients (pts) with metastatic renal cell carcinoma (mRCC)
Abstract #4506
Oral presentation
Monday, June 1
Oral: 11:45 a.m. - 11:57 a.m. CT
Motzer R.
Effect of age and lenvatinib treatment on overall survival for patients with 131I-refractory differentiated thyroid cancer in SELECT
Abstract #6048
Poster presentation
Saturday, May 30
Poster: 1:15 p.m. - 4:45 p.m. CT
Brose M.
Pharmacodynamic biomarkers of outcomes in the phase 3 study of lenvatinib in 131I-refractory differentiated thyroid cancer (SELECT)
Abstract #6014
Poster presentation
Saturday, May 30
Poster: 1:15 p.m. - 4:45 p.m. CT
Panel Discussion: 4:45 p.m. - 6:00 p.m. CT
Tahara M.
Efficacy and safety of lenvatinib for the treatment of patients with 131I-refractory differentiated thyroid cancer with and without prior VEGF-targeted therapy
Abstract #6013
Poster presentation
Saturday, May 30
Poster: 1:15 p.m. - 4:45 p.m. CT
Panel Discussion: 4:45 p.m. - 6:00 p.m. CT
Newbold K.
NEPA Abstracts
Should all antiemetic guidelines recommend adding a NK1 receptor antagonist (NK1RA) in patients (pts) receiving carboplatin (carbo): Efficacy evaluation of NEPA, a fixed combination of the NK1RA, netupitant, and palonosetron
Abstract #9597
Poster presentation
Saturday, May 30
Poster: 1:15 p.m. - 4:45 p.m. CT
Jordan K.
Palonosetron Abstracts
Palonosetron vs ondansetron: Prevention of chemotherapy-induced nausea and vomiting in pediatric patients in a multicycle study
Abstract #10077
Poster presentation
Sunday, May 31
Poster: 8:00 a.m. - 11:30 a.m. CT
Kabickova E.
The information discussed in this release presents investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any of these investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.
About Lenvatinib (Available as LENVIMA™)Lenvatinib is indicated for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC).
Lenvatinib, discovered and developed by Eisai, is a receptor tyrosine kinase (RTK) inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). Lenvatinib also inhibits other RTKs that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1, 2, 3, and 4; the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. Lenvatinib was approved under Priority Review designation for locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer by the FDA in February 2015. Eisai was granted Orphan Drug Designation (ODD) for lenvatinib in various types of thyroid cancer in the United States, Japan, and Europe.
Important Safety Information
Warnings and Precautions
Hypertension was reported in 73% of lenvatinib-treated patients (of which 44% were ≥ Grade 3) and 16% of patients in the placebo group. Control blood pressure prior to treatment and monitor blood pressure after 1 week, then every 2 weeks for the first 2 months, and then at least monthly during treatment.  Withhold lenvatinib for Grade 3 hypertension; resume at a reduced dose when hypertension is controlled at ≤ Grade 2. Discontinue lenvatinib for life-threatening hypertension.
Cardiac dysfunction was reported in 7% of lenvatinib-treated patients (2% Grade 3 or greater). Monitor patients for clinical symptoms or signs of cardiac decompensation. Withhold lenvatinib for development of Grade 3 cardiac dysfunction until improved to Grade 0 or 1 or baseline. Resume at a reduced dose or discontinue lenvatinib depending on the severity and persistence of cardiac dysfunction. Discontinue lenvatinib for Grade 4 cardiac dysfunction.
Arterial thromboembolic events were reported in 5% of lenvatinib-treated patients; events of Grade 3 or greater were 3%. Discontinue lenvatinib following an arterial thrombotic event. Lenvatinib has not been studied in patients who have had an arterial thromboembolic event within the previous 6 months.
4% of lenvatinib-treated patients experienced an increase in ALT and 5% experienced an increase in AST that was Grade 3 or greater. Monitor liver function before initiation and during treatment with lenvatinib. Withhold lenvatinib for the development of ≥ Grade 3 liver impairment until resolved to Grade 0 to 1 or baseline. Resume at a reduced dose or discontinue lenvatinib depending on the severity and persistence of hepatotoxicity. Discontinue lenvatinib for hepatic failure.
Proteinuria was reported in 34% of lenvatinib-treated patients (of which 11% were Grade 3). Monitor for proteinuria before initiation of, and periodically during treatment. Obtain a 24 hour urine protein if urine dipstick proteinuria ≥2+ is detected. Withhold lenvatinib for ≥ 2 grams of proteinuria/24 hours and resume at a reduced dose when proteinuria is <2 gm/24 hours. Discontinue lenvatinib for nephrotic syndrome.
Events of renal impairment were reported in 14% of lenvatinib-treated patients. Renal failure or impairment ≥ Grade 3 was 3% in lenvatinib-treated patients. Withhold lenvatinib for development of Grade 3 or 4 renal failure/impairment until resolved to Grade 0 to 1 or baseline. Resume at a reduced dose or discontinue lenvatinib depending on the severity and persistence of renal impairment. 
Events of gastrointestinal perforation or fistula were reported in 2% of lenvatinib-treated patients.  Discontinue lenvatinib in patients who develop gastrointestinal perforation or life-threatening fistula.
QT/QTc interval prolongation was reported in 9% of lenvatinib-treated patients (2% Grade 3 or greater).  Monitor ECG in patients with congenital long QT syndrome, CHF, bradyarrhythmias, or patients taking drugs known to prolong the QT interval. Monitor and correct electrolyte abnormalities in all patients.  Withhold lenvatinib for the development of ≥ Grade 3 QT interval prolongation. Resume lenvatinib at a reduced dose when QT prolongation resolves to Grade 0 or 1 or baseline.
Hypocalcemia ≥ Grade 3 was reported in 9% of lenvatinib-treated patients. Monitor blood calcium levels at least monthly and replace calcium as necessary during lenvatinib treatment. Interrupt and adjust lenvatinib dosing as necessary depending on severity, presence of ECG changes, and persistence of hypocalcemia.
Reversible posterior leukoencephalopathy syndrome (RPLS) was reported in 3 patients across clinical studies in which 1108 patients received lenvatinib. Confirm the diagnosis of RPLS with MRI. Withhold lenvatinib for RPLS until fully resolved. Resume at a reduced dose or discontinue lenvatinib depending on the severity and persistence of neurologic symptoms.
Hemorrhagic events occurred in 35% of lenvatinib-treated patients and in 18% of the placebo group.  The incidence of Grade 3-5 hemorrhage was similar between arms at 2% and 3%, respectively. The most frequently reported hemorrhagic event was epistaxis (11% Grade 1 and 1% Grade 2). Discontinuation due to hemorrhagic events occurred in 1% of lenvatinib-treated patients. There was one case of fatal intracranial hemorrhage among 16 patients who received lenvatinib and had CNS metastases at baseline. Withhold lenvatinib for the development of Grade 3 hemorrhage until resolved to Grade 0 to 1.  Resume at a reduced dose or discontinue lenvatinib depending on the severity and persistence of hemorrhage. Discontinue lenvatinib in patients who experience Grade 4 hemorrhage.
Lenvatinib impairs exogenous thyroid suppression. Elevation of TSH level above 0.5 mU/L was observed post baseline in 57% of lenvatinib-treated patients. Monitor TSH levels monthly and adjust thyroid replacement medication as needed.
Lenvatinib can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with lenvatinib and for at least 2 weeks following completion of therapy.
Advise women not to breastfeed during treatment with lenvatinib.
Adverse Reactions
The most common adverse reactions observed in lenvatinib-treated patients vs. placebo-treated patients respectively were hypertension (73% vs 16%), fatigue (67% vs 35%), diarrhea (67% vs 17%), arthralgia/myalgia (62% vs 28%), decreased appetite (54% vs 18%), weight decreased (51% vs 15%), nausea (47% vs 25%), stomatitis (41% vs 8%), headache (38% vs 11%), vomiting (36% vs 15%), proteinuria (34% vs 3%), palmar-plantar erythrodysesthesia syndrome (32% vs 1%), abdominal pain (31% vs 11%), and dysphonia (31% vs 5%).
For more information about lenvatinib, click here for the full Prescribing Information.
About Eribulin Mesylate Injection (available as Halaven®)
Eribulin is indicated for patients with metastatic breast cancer who have received at least two chemotherapeutic regimens for the treatment of metastatic breast cancer. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. Eribulin is a synthetic analog of halichondrin B, a natural product that was isolated from the marine sponge Halichondria okadai. First in the halichondrin class, eribulin is a microtubule dynamics inhibitor with a distinct binding profile. Based on in vitro studies, eribulin exerts its effect via a tubulin-based antimitotic mechanism ultimately leading to apoptotic cell death after prolonged and irreversible mitotic blockage.
Important Safety Information
Neutropenia
  • Monitor complete blood counts prior to each dose, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting longer than 7 days
  • Severe neutropenia (ANC <500/mm3) lasting more than 1 week occurred in 12% (62/503) of patients. Patients with elevated liver enzymes >3 × ULN and bilirubin >1.5 × ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia than patients with normal levels
  • Grade 3 and Grade 4 neutropenia occurred in 28% and 29%, respectively, of patients who received eribulin. Febrile neutropenia occurred in 5% of patients and two patients (0.4%) died from complications
Peripheral Neuropathy
  • Patients should be monitored closely for signs of peripheral motor and sensory neuropathy
  • Grade 3 peripheral neuropathy occurred in 8% of patients, and Grade 4 in 0.4% of patients who received eribulin. Delay administration of eribulin until resolution to Grade 2 or less
  • Neuropathy lasting more than 1 year occurred in 5% of patients. Twenty-two percent of patients developed a new or worsening neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days)
  • Peripheral neuropathy (5%) was the most common adverse reaction resulting in discontinuation
Pregnancy Category D
  • Eribulin is expected to cause fetal harm when administered to a pregnant woman and patients should be advised of these risks
QT Prolongation
  • In an uncontrolled ECG study in 26 patients, QT prolongation was observed on Day 8, independent of eribulin concentration, with no prolongation on Day 1. ECG monitoring is recommended for patients with congestive heart failure; bradyarrhythmias; concomitant use of drugs that prolong QT interval, including Class Ia and III antiarrhythmics; and electrolyte abnormalities
  • Correct hypokalemia or hypomagnesemia prior to initiating eribulin and monitor electrolytes periodically during therapy. Avoid in patients with congenital long QT syndrome
Hepatic and Renal Impairment
  • For patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic and/or moderate or severe (CrCl 15-49 mL/min) renal impairment, a reduction in starting dose is recommended
Most Common Adverse Reactions
  • Most common adverse reactions (≥25%) reported in patients receiving eribulin were neutropenia (82%), anemia (58%), asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy (35%), nausea (35%), and constipation (25%)
  • The most common serious adverse reactions reported in patients receiving eribulin were febrile neutropenia (4%) and neutropenia (2%)
For more information about eribulin, click here for the full Prescribing Information.
About Netupitant/Palonosetron (Available as AKYNZEO®) Netupitant/palonosetron (NEPA) is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. NEPA is an oral fixed combination of a 5-HT3 receptor antagonist, palonosetron, and an NK1 receptor antagonist, netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy.
On March 26, 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending that NEPA be granted marketing authorization in the European Union for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin‑based cancer chemotherapy and moderately emetogenic cancer chemotherapy.
Important Safety Information
Warnings and Precautions
  • Hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other 5-HT3 receptor antagonists
  • Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs.  Serotonin syndrome can be life threatening.  Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes, autonomic instability, neuromuscular symptoms, seizures, and gastrointestinal symptoms. Patients should be monitored for the emergence of serotonin syndrome, and if symptoms occur, discontinue NEPA and initiate supportive treatment.  Patients should be informed of the increased risk of serotonin syndrome, especially if NEPA is used concomitantly with other serotonergic drugs
Adverse Reactions
  • Most common adverse reactions: headache, asthenia, dyspepsia, fatigue, constipation and erythema
Drug Interactions
  • Use with caution in patients receiving concomitant medications primarily metabolized by CYP3A4. The plasma concentrations of CYP3A4 substrates can increase when co-administered with NEPA. The inhibitory effect on CYP3A4 can last for multiple days
    • Dexamethasone doses should be reduced when given with NEPA. A two-fold increase in the systemic exposure of dexamethasone was observed 4 days after single dose of netupitant
    • Consider the potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) when administering with NEPA. When administered with netupitant, the systemic exposure to midazolam was significantly increased
  • Avoid concomitant use of NEPA in patients on chronic use of a strong CYP3A4 inducer such as rifampin as this may decrease the efficacy of NEPA
Use in Specific Populations
  • Avoid use of NEPA in patients with severe hepatic impairment, severe renal impairment, or end-stage renal disease
NEPA is available by prescription only.
For more information about NEPA, click here for the full Prescribing Information.
About Palonosetron HCl (available as ALOXI®)
Indication in Pediatrics Palonosetron injection 20mcg/kg (max 1.5mg) is indicated in patients ≥ 1 month up to 17 years of age, for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic chemotherapy.
Indication in Adults Palonosetron injection 0.25 mg is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy, and the prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy.
Important Safety Information
Contraindications
  • Palonosetron is contraindicated in patients known to have hypersensitivity to the drug or any of its components
Warnings and Precautions
  • Hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other 5-HT3 receptor antagonists
  • Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone, but particularly with the use of serotonergic drugs. Serotonin syndrome can be life threatening. Symptoms may include the following combination of signs and symptoms: mental status changes, autonomic instability, neuromuscular symptoms, seizures, and gastrointestinal symptoms. Patients should be monitored for the emergence of serotonin syndrome, and if symptoms occur, discontinue palonosetron and initiate supportive treatment.  Patients should be informed of the increased risk of serotonin syndrome, especially if palonosetron is used concomitantly with other serotonergic drugs.  
Adverse Reactions
  • In pediatric patients, while they require a higher dose of palonosetron, the safety profile is consistent with the established profile in adults; however, adverse reactions were reported in <0.1% of pediatric patients
  • In adults, the most commonly reported adverse drug reactions include headache (9%) and constipation (5%)
Palonosetron is available by prescription only.
For more information about palonosetron, click here for the full Prescribing Information.
About Helsinn and EisaiHelsinn signed a licensing agreement with Eisai Inc. granting Eisai commercial rights for NEPA in the United States. Under the terms of the agreement, Helsinn is responsible for conducting all development activities, obtaining regulatory approvals and holding the New Drug Application (NDA). NEPA is co-promoted in the United States by Eisai Inc. and Helsinn Therapeutics U.S. Inc., the U.S. subsidiary of Helsinn.
About the Helsinn GroupHelsinn is a family run, privately owned pharmaceutical group focused on building quality cancer care with a large portfolio of products. Founded in 1976 with headquarters in Lugano, Switzerland, Helsinn also has operating subsidiaries in Ireland, the U.S. and a representative office in China. Helsinn's business model is focused on the licensing of pharmaceuticals, medical devices and nutritional supplement products in the therapeutic area of cancer care.
Helsinn Group in-licenses early-to-late stage new chemical entities, completing their development by performing preclinical and clinical studies and associated manufacturing activities. Helsinn then prepares necessary regulatory filings in order to achieve marketing approvals worldwide. Helsinn's products are out-licensed to its global network of marketing and commercial partners that have been selected for their local market knowledge. Helsinn supports these partners by providing a full range of product and scientific management services, including commercial, regulatory, and medical marketing advice. In March 2013, Helsinn established a new commercial organization within its subsidiary, Helsinn Therapeutics (U.S.), Inc., in order to conduct direct sales and marketing activities within the U.S. market. Helsinn's products are manufactured according to the highest quality, safety, and environmental standards at Helsinn's GMP facilities in Switzerland and Ireland from where they are then supplied worldwide to customers. Further information on Helsinn Group is available at www.helsinn.com.
About Eisai Inc.At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer's disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US
Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai's global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.
About the SFJ Pharmaceuticals GroupThe SFJ Pharmaceuticals Group, which includes SFJ Pharma Ltd., is a global drug development company, which provides a unique co-development partnering model for some of the world's top pharmaceutical and biotechnology companies. SFJ uses its financial strength and core team of pharmaceutical development experts to provide highly customized partnering models in which SFJ provides the funding and clinical development supervision, necessary to obtain regulatory approval for some of the most promising drug development programs of pharmaceutical and biotechnology companies.

Contacts:
Media Inquiries
Laurie Landau
Eisai Inc.
(201) 746-2510
Investor Inquiries
Alex Scott
Eisai Inc.
(201) 746-2177

SOURCE Eisai Inc.


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