Press Releases

New Data on Eribulin Mesylate Injection to Be Presented at the 2016 San Antonio Breast Cancer Symposium Explore Potential of Regimens in Treatment of Metastatic Breast Cancer

Nov 30, 2016

WOODCLIFF LAKE, N.J., Nov. 30, 2016 /PRNewswire/ --  Eisai Inc. announced today the presentation of new data from studies of eribulin, marketed under the brand name Halaven®, at the 2016 San Antonio Breast Cancer Symposium (SABCS). Two ongoing studies are evaluating eribulin as part of investigational combination regimens for metastatic breast cancer (MBC), and another study evaluated use of eribulin in a real-world setting of patients with metastatic triple-negative breast cancer (mTNBC). Eribulin is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. SABCS 2016 will be held from December 6-10 in San Antonio, Texas.

"Combination regimens have transformed the treatment of a number of cancers, and ongoing research will continue to assess the potential of different combinations to further improve care. At Eisai, we are committed to researching the potential of our medicines as part of combination regimens for the treatment of select cancers, including investigational combinations with eribulin for the treatment of advanced breast cancer," said Alton Kremer, MD, PhD, Chief Clinical Officer and Chief Medical Officer, Oncology Business Group at Eisai. "It is our goal to generate innovative solutions for patients and their families worldwide, and we look forward to seeing whether potential in the lab ultimately can result in benefits for patients."

This release discusses investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such FDA-approved products will successfully complete clinical development or gain FDA approval.

Presentations of note include:

  • Two Phase 1b/2 studies evaluating eribulin as part of a combination regimen for the treatment of patients with metastatic breast cancer, including:
    • Interim results from a study of eribulin in combination with pembrolizumab in the first-, second- or third-line setting in patients with metastatic triple-negative breast cancer to determine safety, tolerability and objective response rate
    • Details of the design of a study that will assess eribulin in combination with PEGylated recombinant human hyaluronidase (PEGPH20) in patients with human epidermal growth factor receptor 2-negative, high-hyaluronan metastatic breast cancer
       
  • A chart extraction study evaluating the real-world utilization and outcomes of eribulin in the treatment of patients with metastatic triple-negative breast cancer
     
  • The epidemiological, retrospective CASCADE study of overall survival in patients with advanced breast cancer based on treatment line and tumor immunotype from 13 public Spanish hospitals to assess the efficacy of treatment with each successive therapy cycle

Abstract Name

Session (All times are U.S. CT)

A randomized, open-label, multicenter, Phase 1b/2 study
of eribulin mesylate in combination with PEGylated
recombinant human hyaluronidase in patients with
human epidermal growth factor receptor 2-negative, high-
hyaluronan metastatic breast cancer

Pub #OT2-02-02

Poster Presentation

Thursday, Dec. 8, 2016, 5-7 p.m.

Location: Hall 1

R.H. Alvarez, et al.

Eribulin impairs TGF-β type I receptor localization and
signaling in BT-549 cells

 

This preclinical analysis evaluated the hypothesis that a
short-term treatment of breast cancer cells with eribulin
or 3 other clinically relevant microtubule targeting agents
would differentially disrupt interphase microtubules and
alter the transport and downstream signaling of the TGF-
β type 1 receptor.

Pub #P4-04-04

Poster Presentation

Friday, Dec. 9, 2016, 7:30-9 a.m.

Location: Hall 1

R. Kaul, et al.

Phase 1b/2 study to evaluate eribulin mesylate in
combination with pembrolizumab in patients with
metastatic triple-negative breast cancer

Pub #P5-15-02

Poster Presentation

Friday, Dec. 9, 2016, 5-7 p.m.

Location: Hall 1

S. Tolaney, et al.

Utilization and outcomes of eribulin in triple negative
metastatic breast cancer: Real-world findings

Pub #P5-15-16

Poster Presentation

Friday, Dec. 9, 2016, 5-7 p.m.

Location: Hall 1

J.K. Kish, et al.

CASCADE study: Rapid survival decline per treatment
line in metastatic breast cancer

 

 

               

Pub #P6-09-33

Poster Presentation

Saturday, Dec. 10, 2016, 7:30-9 a.m.

Location: Hall 1

J. García, et al.

About Metastatic Breast Cancer 
Metastatic breast cancer is an advanced stage of the disease that occurs when cancer spreads beyond the breast to other parts of the body. In 2016, an estimated 246,660 women will be diagnosed with breast cancer in the United States and an estimated 40,450 women will die from the disease. It is estimated that approximately 5 to 10 percent of women with breast cancer will have metastatic disease at the time of diagnosis. Of these women, an estimated one in five is expected to survive five years.

About Halaven® (eribulin mesylate) Injection 
Halaven® (eribulin mesylate) is a microtubule dynamics inhibitor indicated for the treatment of patients with:

  • Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.
  • Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.

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. First in the halichondrin class, Halaven is a microtubule dynamics inhibitor. Eribulin is believed to work primarily via a tubulin-based mechanism that causes prolonged and irreversible mitotic blockage, ultimately leading to apoptotic cell death. Additionally, in preclinical studies of human breast cancer, eribulin demonstrated complex effects on the tumor biology of surviving cancer cells, including increases in vascular perfusion resulting in reduced tumor hypoxia, and changes in the expression of genes in tumor specimens associated with a change in phenotype, promoting the epithelial phenotype, opposing the mesenchymal phenotype. Eribulin has also been shown to decrease the migration and invasiveness of human breast cancer cells.

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 Eisai Inc.
At Eisai Inc., human health care (hhc) is our goal. We give our first thought 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, 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.


 

CONTACT: Media Inquiries - Laurie Landau, Eisai Inc., (201) 746-2510; Investor Inquiries - Ivor Macleod, Eisai Inc., (201) 746-2660

 

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