WOODCLIFF LAKE, N.J., May 24, 2016 /PRNewswire/ -- Eisai Inc. announced today presentations of new analyses of studies supporting U.S. Food and Drug Administration (FDA) approvals at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting. These approvals included the use of Halaven® (eribulin mesylate) in advanced liposarcoma following a prior anthracycline-containing regimen and Lenvima® (lenvatinib) in locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-R DTC), and in advanced renal cell carcinoma (RCC) in combination with everolimus following one prior anti-angiogenic therapy. ASCO 2016 will be held from June 3-7 in Chicago.
"Eisai's data at this year's ASCO further explore the registration trials that cement the value of Eisai's principal oncology treatments," said Alton Kremer, MD, PhD, Chief Clinical Officer and Chief Medical Officer, Oncology Business Group at Eisai. "Halaven offers a dual-tumor survival advantage, as the only single agent proven to prolong overall survival in third-line metastatic breast cancer and in advanced liposarcoma. Additionally, Lenvima has demonstrated dramatic efficacy results for patients in both its initial pivotal trial for RAI-refractory differentiated thyroid cancer and its latest registration trial in advanced renal cell carcinoma."
Presentations of note include:
Dr. Kremer further elaborated: "Coming off of two Priority Review approvals in the past four months, we are excited to share our expanded understanding of the value of eribulin and lenvatinib across multiple cancers at this year's ASCO Annual Meeting. Our clinical programs in oncology support our company's broader human health care (hhc) mission, demonstrating Eisai's ongoing commitment to furthering our oncology portfolio with the goal of improving outcomes for patients with difficult-to-treat cancers."
Abstract Name |
Session (All times are Central) |
Halaven Abstracts | |
Phase 1 multicenter, open-label study to establish the maximum tolerated dose of two administration schedules of E7389 (eribulin) liposomal formulation in patients with solid tumors |
Abstract #2524/Poster Board #224 Poster Session Sunday, June 5, 2016, 8-11:30 a.m. Location: Hall A Ishtiaq Husain Zubairi, MBBS, MRCP, MSc |
Subtype-specific activity in liposarcoma (LPS) patients (pts) from a Phase 3, open-label, randomized study of eribulin versus dacarbazine in pts with advanced LPS and leiomyosarcoma |
Abstract #11037/Poster Board #163 Poster Session Monday, June 6, 2016, 8-11:30 a.m. Location: Hall A Sant P. Chawla, MD |
Evaluation of Quality of Life at Progression in Patients with Soft Tissue Sarcoma
This analysis of health-related quality of life utilized patient-reported data via the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 assay. |
Abstract #11015/Poster Board #141 Poster Session Monday, June 6, 2016, 8-11:30 a.m. Location: Hall A Stacie Hudgens
To be discussed at the Poster Discussion Session on Monday, June 6, 2016, 3-4:15 p.m., at S406 |
Lenvima Abstracts | |
Response to lenvatinib treatment in patients with radioiodine-refractory differentiated thyroid cancer: Updated results from SELECT
As duration of objective response (DOR) for patients in the lenvatinib group was not reached at the time of primary analysis, this poster looks at updated DOR and PFS results from the Phase 3 registration SELECT trial of lenvatinib vs. placebo. |
Abstract #6089/Poster Board #411 Poster Session Saturday, June 4, 1-4:30 p.m. Location: Hall A Andrew G. Gianoukakis, MD |
Phase 2 study of lenvatinib in patients with differentiated, medullary, and anaplastic thyroid cancer: final analysis results |
Abstract #6088/Poster Board #410 Saturday, June 4, 1-4:30 p.m. Location: Hall A Shunji Takahashi, MD, PhD |
Subgroup analyses and updated overall survival from the Phase 2 trial of lenvatinib (LEN), everolimus (EVE), and LEN+EVE in metastatic renal cell carcinoma |
Abstract #4553/Poster Board #175 Poster Session Monday, June 6, 2016, 1-4:30 p.m. Location: Hall A Thomas E. Hutson, DO, PharmD |
This release discusses investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.
About Halaven® (eribulin mesylate) Injection
Halaven® (eribulin mesylate) is a microtubule dynamics inhibitor indicated for the treatment of patients with:
First in the halichondrin class, Halaven is a microtubule dynamics inhibitor with a distinct binding profile. Discovered and developed by Eisai, eribulin is a synthetic analog of halichondrin B, a natural product that was isolated from the marine sponge Halichondria okadai. 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. In addition, treatment of human breast cancer cells with eribulin caused changes in cell structure and gene expression as well as decreased migration and invasiveness in vitro. Eribulin treatment in preclinical models of human breast cancer was also associated with increased vascular perfusion and permeability in the tumor cores, resulting in reduced tumor hypoxia, and changes in the expression of genes in tumor specimens associated with a change in phenotype.
Important Safety Information
Warnings and Precautions
Neutropenia: Severe neutropenia (ANC <500/mm3) lasting >1 week occurred in 12% of patients with mBC and liposarcoma or leiomyosarcoma. Febrile neutropenia occurred in 5% of patients with mBC and 2 patients (0.4%) died from complications. Febrile neutropenia occurred in 0.9% of patients with liposarcoma or leiomyosarcoma, and fatal neutropenic sepsis occurred in 0.9% of patients. Patients with mBC 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. Monitor complete blood cell 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 >7 days.
Peripheral Neuropathy: Grade 3 peripheral neuropathy occurred in 8% of patients with mBC (Grade 4=0.4%) and 22% developed a new or worsening neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days). Neuropathy lasting >1 year occurred in 5% of patients with mBC. Grade 3 peripheral neuropathy occurred in 3.1% of patients with liposarcoma and leiomyosarcoma receiving HALAVEN and neuropathy lasting more than 60 days occurred in 58% (38/65) of patients who had neuropathy at the last treatment visit. Patients should be monitored for signs of peripheral motor and sensory neuropathy. Withhold HALAVEN in patients who experience Grade 3 or 4 peripheral neuropathy until resolution to Grade 2 or less.
Embryo-Fetal Toxicity: HALAVEN can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with HALAVEN and for at least 2 weeks following the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with HALAVEN and for 3.5 months following the final dose.
QT Prolongation: Monitor for prolonged QT intervals in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities. Correct hypokalemia or hypomagnesemia prior to initiating HALAVEN and monitor these electrolytes periodically during therapy. Avoid in patients with congenital long QT syndrome.
Adverse Reactions
In patients with mBC receiving HALAVEN, the most common adverse reactions (≥25%) were neutropenia (82%), anemia (58%), asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy (35%), nausea (35%), and constipation (25%). Febrile neutropenia (4%) and neutropenia (2%) were the most common serious adverse reactions. The most common adverse reaction resulting in discontinuation was peripheral neuropathy (5%).
In patients with liposarcoma and leiomyosarcoma receiving HALAVEN, the most common adverse reactions (≥25%) reported in patients receiving HALAVEN were fatigue (62%), nausea (41%), alopecia (35%), constipation (32%), peripheral neuropathy (29%), abdominal pain (29%), and pyrexia (28%). The most common (≥5%) Grade 3-4 laboratory abnormalities reported in patients receiving HALAVEN were neutropenia (32%), hypokalemia (5.4%), and hypocalcemia (5%). Neutropenia (4.9%) and pyrexia (4.5%) were the most common serious adverse reactions. The most common adverse reactions resulting in discontinuation were fatigue and thrombocytopenia (0.9% each).
Use in Specific Populations
Lactation: Because of the potential for serious adverse reactions in breastfed infants from eribulin mesylate, advise women not to breastfeed during treatment with HALAVEN and for 2 weeks after the final dose.
Hepatic and Renal Impairment: A reduction in starting dose is recommended for patients with mild or moderate hepatic impairment and/or moderate or severe renal impairment.
For more information about HALAVEN, click here for the full Prescribing Information.
About LENVIMA® (lenvatinib)
LENVIMA® (lenvatinib) is a kinase inhibitor that is indicated for:
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 VEGFR1-3. 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 FGFR1-4; the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. The combination of lenvatinib and everolimus showed increased anti-angiogenic and anti-tumor 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 renal cell cancer greater than each drug alone.
Important Safety Information
Warnings and Precautions
Adverse Reactions
Use in Specific Populations
For more information about LENVIMA, click here for the full Prescribing Information.
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 discover and develop innovative therapies to help address unmet medical needs.
Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Each group functions as an end-to-end global business with discovery, development, manufacturing and marketing capabilities. Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US.
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