news – page 13 – eisai china lnc.-威尼斯人888

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced that the latest results from the cohort targeting patients with her2-negative breast cancer in the phase i clinical trial for the new liposomal formulation (e7389-lf) of the in-house discovered anti-cancer treatment halaven^® (generic name: eribulin mesylate, “eribulin”) were presented (abstract number: 346p) at the european society for medical oncology (esmo) virtual congress 2020.

e7389-lf is a new formulation using liposomes made of a lipid bilayer to encapsulate the halichondrin-class microtubule dynamics inhibitor eribulin. in tumor tissue, gaps exist among vascular endothelial cells due to incomplete vasculature, which is thought to allow for penetration by macromolecules. this condition, in addition to incomplete lymphatic function, is predicted to enable high-molecular-weight drugs including liposomal formulations to be respectively delivered and retained in greater amounts in tumors as compared to in normal tissue, through enhanced permeability and retention (epr) effects. thus e7389-lf is expected to improve the concentration of eribulin in tumor tissues.

this presentation reported efficacy and safety results of e7389-lf in a cohort enrolling 28 patients with recurrent (her2-negative) breast cancer (hormone receptor positive: 21, triple negative: 7) who had previously undergone treatment with anthracycline or taxane class treatments and had no prior treatment with eribulin (data cutoff: january 24, 2020, progression free survival and overall survival cutoff: april 17, 2020), as part of the open-label, phase i clinical trial (study 114) on patients with select solid tumors who had previously undergone treatment. patients were treated with e7389-lf 2.0 mg/m² body surface area (as free eribulin) intravenously once every three weeks, and demonstrated an overall response rate (orr) of 35.7% (95% confidence interval (ci): 18.6-55.9) in the her2-negative breast cancer cohort as a whole. within the cohort, hormone receptor positive patients demonstrated an orr of 42.9% (95% ci: 21.8-66.6) and triple negative patients demonstrated an orr of 14.3% (95% ci: 0.4-57.9). the disease control rate combining stable disease rate, partial response rate, and complete response rate was 89.3% (95% ci: 71.8-97.7). additionally, progression-free survival (pfs) was a median of 5.7 months (95% ci: 3.9-8.3), and the median overall survival (os) was not reached (95% ci: 10.3 – not reached). adverse events of grade 3 or above (top 5) were neutropenia (67.9%), leukopenia (42.9%), thrombocytopenia (32.1%), febrile neutropenia (25.0%), and increased alanine aminotransferase (21.4%), which were consistent with the safety profile of eribulin to date. additionally, preventive treatment with the g-csf (granulocyte colony stimulating factor) pegfilgrastim demonstrated a decrease in the ratio of febrile neutropenia occurrence (with treatment: 10.0%, without treatment: 33.3%).

eisai positions oncology as a key franchise area and aims to create innovative drugs that act towards curing cancer. eisai will continue to create innovation in the development of new drugs based on cutting-edge cancer research, and aims to make continuous efforts to meet the diversified needs of and increase the benefits provided to patients with cancer, their families, and healthcare professionals.

media inquiries:
public relations department,
eisai co., ltd.
81-(0)3-3817-5120

[notes to editors]

1. about e7389-lf

e7389-lf is a new formulation designed for more efficient delivery of the halichondrin-class microtubule dynamics inhibitor “halaven” (eribulin mesylate) into cancer cells by liposome envelopment. a phase i clinical study is currently being conducted on select solid tumors in japan. additionally, a phase ib/ii clinical trial on the combination therapy of e7389-lf and nivolumab targeting select solid tumors is currently being conducted in japan in collaboration with ono pharmaceutical co., ltd.

2. about halaven (generic name: eribulin mesylate)

halaven is in the halichondrin class of microtubule dynamics inhibitors with a novel mechanism of action. structurally, halaven is a simplified and synthetically produced version of halichondrin b, a natural product isolated from the marine sponge halichondria okadai. halaven is believed to work by inhibiting the growth phase of microtubule dynamics which prevents cell division. in addition, non-clinical studies showed halaven’s unique actions in the tumor microenvironment such as an increase in vascular perfusion and permeability in tumor cores¹, promotion of the epithelial state, decrease in capacity of breast cancer cells to migrate², etc.

halaven was first approved as a treatment in the united states in november 2010 for patients with metastatic breast cancer. halaven is currently approved for use in the treatment of breast cancer in over 75 countries worldwide, including japan, china and countries in europe, the americas and asia. furthermore, halaven was first approved as a treatment for soft tissue sarcoma in the united states in january 2016, and is approved in over 65 countries including japan and in europe and asia. furthermore, halaven has been designated as an orphan drug for soft tissue sarcoma in the united states and japan.
specifically, halaven is approved for the following indications.
in the united states 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.

in japan for the treatment of patients with:

• inoperable or recurrent breast cancer, soft tissue sarcoma

in europe for the treatment of adult patients with:

•  locally advanced or metastatic breast cancer who have received a prior anthracycline-containing regimen for advanced disease. prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments.
•  unresectable liposarcomas who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.

two open-label, randomized, phase iii trials (embrace and study 301) were conducted for halaven in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane. based on the pooled analysis of the combined results³, overall survival (os) was extended significantly in the halaven group compared to the control group (hazard ratio 0.85 [95% confidence interval (ci) = 0.77-0.95] p = 0.003, halaven median os: 15.2 months vs. control median os: 12.8 months). progression free survival (pfs) was also extended in the halaven group compared to the control group (hazard ratio 0.90 [95% ci = 0.81-0.997] p = 0.046, halaven median pfs: 4.0 months vs. control median pfs: 3.4 months).

the overall response rate (orr) in the her2-negative breast cancer group was 13.5%. within the group, an orr of hormone receptor positive patients was 14.3% and that of triple negative patients was 12.0%. median pfs in the her2-negative breast cancer group was 4.0 months.

regarding the safety profile from the combined analysis, there were no major differences among the respective clinical studies. patients in these phase iii studies received halaven (1.4 mg/m² administered intravenously on day 1 and day 8) every 21 days.

¹ funahashi y et al., eribulin mesylate reduces tumor microenvironment abnormality by vascular remodeling in preclinical human breast cancer models. cancer sci., 2014; 105, 1334-1342
² yoshida t et al., eribulin mesilate suppresses experimental metastasis of breast cancer cells by reversing phenotype from epithelial-mesenchymal transition (emt) to mesenchymal-epithelial transition (met) states. br j cancer, 2014; 110, 1497-1505
³ twelves c et al., efficacy of eribulin in women with metastatic breast cancer: a pooled analysis of two phase 3 studies. breast cancer res treat, 2014; 148, 553-561

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it will take over by transfer the manufacturing and marketing approval of parkinson’s disease treatment equfina^® 50mg tablets (safinamide mesilate, “equfina”) in japan from meiji seika pharma co., ltd. (headquarters: tokyo, “meiji”), effective september 23, 2020.

in japan, meiji conducted clinical studies of equfina and obtained its manufacturing and marketing approval in september 2019. eisai has exclusively sold equfina in japan as a distributor. based on the license agreement signed between eisai and meiji, eisai will take over by transfer the manufacturing and marketing approval of equfina from meiji. eisai, as the manufacturer and distributor of equfina in japan, will continue to provide information on the proper usage of equfina.

equfina, developed by meiji in japan, is a once-daily oral treatment for parkinson’s disease. it is a selective and reversible monoamine oxidase b (mao-b) inhibitor that helps to maintain the density of endogenous dopamine and exogenous dopamine from levodopa-containing drugs in the brain (dopaminergic mechanism). in addition, equfina blocks voltage-dependent sodium ion channels and inhibits glutamate release (non-dopaminergic mechanism). in the clinical studies conducted in japan for parkinson’s disease patients under treatment with a drug containing levodopa, the extension of levodopa’s duration of effect (“on” time) of one hour or more and improvement of motor functions were shown. improvement effect on the wearing off phenomenon is expected.

following the completion of the transfer, eisai will continue to deliver equfina, a new option for parkinson’s disease treatment in japan to patients, thereby increasing the amount of time that they can freely engage in activities on their own initiative. eisai will further contribute to improving the qol of patients and enabling their families to create a vibrant daily life.

media inquiries:
public relations department,
eisai co., ltd.
81-(0)3-3817-5120

[notes to editors] 

1. about equfina (safinamide mesylate “safinamide”)

safinamide is a selective monoamine oxidase b (mao-b) inhibitor that reduces the degradation of excreted dopamine, helping to maintain the density of dopamine in the brain. additionally, safinamide blocks sodium ion channels and inhibits glutamate release, and as such has potential as a new parkinson’s disease treatment which possesses both dopaminergic and non-dopaminergic mechanisms.

safinamide was discovered and developed by newron pharmaceuticals s.p.a. (headquarters: milan, italy, “newron”). in 2011, newron entered into a licensing agreement with meiji, granting meiji exclusive rights to develop, manufacture and commercialize the drug in japan and asia. eisai has exclusive rights for marketing in japan, as well as for development and marketing in asia* based on a licensing agreement signed between eisai and meiji. safinamide mesilate is marketed under the name “xadago” in 15 countries in europe, the united states and australia, and under the name “onstryv” in canada.

* south korea, chinese taiwan, brunei, cambodia, laos, malaysia, the philippines, indonesia, thailand, vietnam, myanmar, singapore, hksa, and chinese macau

2．about parkinson’s disease

parkinson’s disease is a neurodegenerative disease that causes motor impairment such as shaking in the limbs, muscular rigidity and shuffling gait, as well as non-motor impairment such as sensation impairment with pain, insomnia, and autonomic failure. it is caused by degeneration of the dopamine nervous system, which leads to a shortage of dopamine, a neurotransmitter in the brain. according to an estimate by the japanese society of neurology, there are approximately 200,000 patients suffering from parkinson’s disease in japan.¹ also, approximately 3 million patients suffer from parkinson’s disease in asia.² the number of patients is increasing due to aging of the population.³ levodopa is widely used to treat parkinson’s disease by replenishing the brain’s supply of dopamine. however, as the disease progresses, the duration of effect of a drug containing levodopa (“on” time) decreases, and there are cases of parkinson’s disease symptoms returning before the next dose (“wearing-off” phenomenon). to prevent the “wearing-off” phenomenon, combination therapy with a drug that has a different mechanism of action to a drug containing levodopa is administered.

3. about meiji seika pharma

in order to protect and improve people’s health and lives, meiji seika pharma, as a “speciality and generic pharmaceuticals company”, runs its pharmaceutical business in two main fields: infectious disease and central nervous system disorders, as well as generic drugs. meiji seika pharma strives to respond to diversified medical needs and to contribute to the well-being of people worldwide.

for details, please visit its corporate website:

¹ japanese society of neurology. treatment and management guideline 2018 for parkinson’s disease
² e ray dorsey et al. global, regional, and national burden of parkinson’s disease, 1990–2016: a systematic analysis for the global burden of disease study 2016 lancet neurol. 2018;17:939–53
³ japan intractable diseases information center: 

on september 1, 2020, the second hhc summit of eisai china holdings ltd. (hereinafter referred to as “eisai china”) was successfully held in shanghai. feng yanhui, senior vice president of eisai global, president of eisai china, and chairman of eisai china hhc committee, led the senior management team of eisai china and leaders of various departments to attend the summit.

feng yanhui delivered a speech 

feng yanhui said at the summit that hhc is based on well-being improvement for patients and their families to achieve business innovation; hhc is the mission, core philosophy and original intention of eisai china. all employees of eisai china should not forget the original intention, carry forward the hhc spirit, meet the unmet needs of patients and their families, and keep increasing their business innovation ability in their daily work.

the highlight of this summit was the combination of theory and practice. at the same time, 8 groups of patients were invited, and all participants were divided into 8 groups. a socialization process was undergone, that is, the staff members communicated with the patients, their families and people living together with them, discovered their needs, and shared and discussed hhc needs and put forward innovative ideas.

communication with patients (socialization)  

at the summit, awards were presented to those award-winning hhc projects and outstanding hhc fulfillers of eisai china in the 2019 fiscal year.

hhc committee members had a group photo taken with hhc award-winning representatives 

hhc stands for the initials of “human health care”, is the foundation of the global concept of eisai, and is consistent with the nursing concept of florence nightingale, the founder of modern nursing. the hhc logo is directly derived from the handwriting of florence nightingale.

the hhc philosophy is realized through the knowledge creation model -seci model, which is socialization, externalization, combination, and internalization respectively. the unmet needs of patients and their families are discovered through practice with the above model, and are met through actual work to realize business innovation.

sahne medical spray is the first otc drug spray-type lotion containing heparinoid

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has launched sahne^® medical spray and sahne^® medical cream (both are category-2 otc drugs, “sahne medical”) on august 25, 2020 at pharmacies and drugstores throughout japan, as a new product of the sahne brand lineup which has been a favored hand care for generations.

eisai conducted a survey of 1,000 women in their 40s to 50s in april 2020. as a result, it was found that approximately 70% of the subjects felt that the dryness of their skin and/or the dry skin expanse had increased compared to its condition five years ago. additionally, a number of comments regarding the discomfort of dryness from people with dry skin were received as follows: “the dryness has spread to my thighs, shins, sides, and back.”, “i’m distracted just by my underwear rubbing against my skin.”, and “my dry skin flakes stick inside my clothes whenever i get undressed, which makes me uncomfortable.” it is considered that the skin condition of women after their late 30s requires more reliable moisturizing effects of pharmaceuticals, since the amounts of sebum, natural moisturizing factors, and intercellular lipids in the stratum corneum necessary for water retention of the skin decrease.

“sahne medical” is a category-2 otc drug containing the active ingredient “heparinoid”, which exerts a high moisturizing effect against dry skin (xeroderma) that worsens with age. heparinoid penetrates into the stratum corneum, increases natural moisturizing factors, and restores the structure of intercellular lipids in the stratum corneum to moisturize dry skin.

there are two types of product lines, spray and cream, which can be selected depending on the part of the body where the product is applied and/or the principles of tpo (time, place and occasion). “sahne medical spray” is the first otc drug spray-type lotion containing heparinoid. this product is handy for the consumer to use on the back, side and back of thigh, where it is difficult to apply the medicine by themselves, as it features a container that can be sprayed upside down and a fine mist-like lotion. in addition, the tube-type “sahne medical cream” is recommended for relieving unbearable discomfort of dryness upon going out, as it is convenient to carry.

the sahne brand has continued to be a gentle companion to the daily lives of many people for 66 years since its launch. with the new launch of sahne medical, a pharmaceutical product, eisai is now able to provide a remedy for skin problems that it had not been able to contribute to before. eisai will further respond to the wishes of consumers who want to be relieved of the discomfort of dry skin, with the moisturizing effect of pharmaceutical care products and the gentle nature of sahne products.

media inquiries:
public relations department,
eisai co., ltd.
81-(0)3-3817-5120

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and msd k.k. (headquarters: tokyo, president: jannie oothuizen, “msd”), a subsidiary of merck & co., inc., kenilworth, n.j., u.s.a., announced today that eisai has submitted an application in japan for the additional indication of treatment of unresectable thymic carcinoma for multiple receptor tyrosine kinase inhibitor lenvima ^® (generic name: lenvatinib mesylate). in june 2020, lenvima received orphan drug designation in japan for unresectable thymic carcinoma.

this application is based on the results of an open-label, single-arm, multicenter, investigator-initiated clinical phase ii study (ncch1508) conducted in japan, evaluating lenvima as a single agent in 42 patients with thymic carcinoma previously treated with at least one platinum-based regimen.

the primary endpoint of this study, objective response rate (orr, assessed by independent imaging review) was 38.1% (90% confident interval (ci): 25.6-52.0). this study met its endpoint as the lower value of the ci exceeded the pre-specified statistical criteria, a threshold orr of 10%. the most common three treatment-related adverse events were hypertension (88.1%), proteinuria (71.4%), and palmar-plantar erythrodysesthesia syndrome (69.0%), which is consistent with the safety profile observed in the previously approved indications.

thymic carcinoma is an extremely rare disease with low prevelance. it is estimated that there are only 140 to 200 patients in japan. for unresectable thymic carcinoma, platinum-based first-line therapy is recommended. however, since the standard treatment has not yet been established for second-line or later therapy, it remains a disease with a poor prognosis, thus the development of new therapeutic agents is desired.

eisai and msd have been collaborating through the provision of information on lenvima in japan since october 2018, and will work together to expedite the maximization of lenvima’s contribution to patients with cancer.

media inquiries
eisai co., ltd.
public relations department
tel： 81-(0)3-3817-5120

msd k.k.
communication department
tel： 81-(0)3-6272-1001

1. about lenvima^® (generic name: lenvatinib mesylate)
lenvima, discovered and developed by eisai, is a kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (vegf) receptors vegfr1 (flt1), vegfr2 (kdr), and vegfr3 (flt4). lenvima inhibits other kinases 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. in syngeneic mouse tumor models, lenvima decreased tumor-associated macrophages, increased activated cytotoxic t cells. currently, lenvima has been approved for monotherapy as a treatment for thyroid cancer in over 65 countries including japan, the united states, in europe and in asia, and for unresectable hepatocellular carcinoma in over 65 countries including japan, the united states, in europe, china and in asia. additionally, it is also approved in combination with everolimus as a treatment for renal cell carcinoma following prior antiangiogenic therapy in over 55 countries, including the united states, in europe (where it was launched under the brand name kisplyx^® for renal cell carcinoma) and in asia. in addition, it is approved in combination with keytruda^® (generic name: pembrolizumab) as a treatment for advanced endometrial cancer that is not microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr) who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation in countries including the united states, australia, and canada. continued approval for this indication is contingent upon verification and description of clinical benefit in the confirmatory trials.

2. about ncch1508 (remora study)*
this study is an open-label, single-group, multicenter, investigator initiated clinical phase ii study (8 centers nationwide including the national cancer center hospital). forty-two patients with thymic carcinoma were enrolled who had progressed after at least one prior platinum-based therapy. the primary endpoint is objective response rate (orr) by independent image review using recist1.1, and secondary efficacy endpoints include progression free survival (pfs), disease control rate (dcr), and overall survival (os). lenvatinib was administered at a starting dose of 24 mg once daily, and the dose was appropriately reduced according to the patient’s condition until the disease progressed or unacceptable toxicity was observed.

for efficacy analysis, orr was 38.1% (90% confidence interval (ci): 25.6-52.0) and the best overall response was 38.1% for partial response, 57.1% for stable disease, and 4.8% for disease progression. pfs (median) was 9.3 months (95% ci: 7.7-13.9), dcr was 95.2% (95% ci: 83.8-99.4), and the median os was not reached (95% ci: 16.1-nr (not reached)). the major treatment-related adverse events** (more than 30%) were hypertension (88.1%), proteinuria (71.4%), palmar-plantar erythrodysesthesia syndrome (69.0%), hypothyroidism (64.3%), diarrhea (57.1%), thrombocytopenia (54.8%), decreased appetite (42.9%), weight loss (40.5%), dysphonia (40.5%), increased aspartate aminotransferase (33.3%), malaise (33.3%), and stomatitis (33.3%).

*   jun sato, miyako satouchi, shoichi itoh, yusuke okuma, seiji niho, hidenori mizugaki, haruyasu murakami, yasuhito fujisaka, toshiyuki kozuki, kenichi nakamura, yukari nagasaka, mamiko kawasaki, tomoaki yamada, ryunosuke machida, aya kuchiba, yuichiro ohe, noboru yamamoto; lenvatinib in patients with advanced or metastatic thymic carcinoma (remora): a multicentre, phase 2 trial. the lancet oncology, 2020, vol.21, no. 6, p843-850
** the adverse event data used for the application has beed updated from the data in the paper.

3. about the eisai and merck & co., inc., kenilworth, n.j., u.s.a. strategic collaboration
in march 2018, eisai and merck & co., inc., kenilworth, n.j., u.s.a., known as msd outside the united states and canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvima. under the agreement, the companies will jointly develop, manufacture and commercialize lenvima, both as a monotherapy and in combination with merck & co., inc., kenilworth, n.j., u.s.a.’s anti-pd-1 therapy keytruda^® (generic name: pembrolizumab).

in addition to ongoing clinical studies evaluating the lenvima plus keytruda combination across several different tumor types, the companies have jointly initiated new clinical studies through the leap (lenvatinib and pembrolizumab) clinical program and are evaluating the combination in 13 different tumor types (endometrial carcinoma, hepatocellular carcinoma, melanoma, non-small cell lung cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck, urothelial cancer, biliary tract cancer, colorectal cancer, gastric cancer, glioblastoma, ovarian cancer and triple-negative breast cancer) across 19 clinical trials.

4. about eisai co., ltd.
eisai is a leading global research and development-based pharmaceutical company headquartered in japan, with approximately 10,000 employees worldwide. eisai defines our corporate mission as “giving first thought to patients and their families and to increasing the benefits health care provides,” which we call our human health care(hhc) philosophy. we strive to realize our hhc philosophy by delivering innovative products in therapeutic areas with high unmet medical needs, including oncology and neurology. in the spirit of hhc, eisai takes that commitment even further by applying our scientific expertise, clinical capabilities and patient insights to discover and develop innovative solutions that help address society’s toughest unmet needs, including neglected tropical diseases and the sustainable development goals.

for more information about eisai, please visit  (for global), (for u.s.) or  (for europe, middle east, africa), and connect with us on twitter ( and ) and  (for u.s.).

5. about msd
for more than 125 years, msd has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. msd is a trade name of merck & co., inc., with headquarters in kenilworth, n.j., u.s.a. we demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. today, msd continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as hiv and ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. for more information, visit  and connect with us on , and .