news – page 6 – eisai china lnc.-开元体育官网下载手机版

news – page 6 – eisai china lnc.-开元体育官网下载手机版

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has received notification from japan’s ministry of health, labour, and welfare (mhlw) that the “all-case study” specified post-marketing observational study condition required at the time of approval of antiepileptic agent inovelon® tablets 100 mg and 200 mg (rufinamide) as an adjunctive therapy to other antiepileptic drugs (aeds) for treatment of lennox-gastaut syndrome (lgs) has been cleared.

in march 2013, the mhlw approved inovelon as an adjunctive therapy with other antiepileptic drugs for tonic and atonic seizures associated with lgs showing insufficient response to other antiepileptics, with the following condition: “because of the very limited number of subjects included in the japanese clinical trials, the applicant is required to conduct a post-marketing observational study in all patients until data from a certain number of patients is accumulated after its launch in the market, in order to identify the background information of patients treated with the product and collect safety and efficacy data on the product in the early post-marketing period, and thereby take necessary measures to ensure proper use of the product.”

based on the safety data in 702 patients and efficacy data in 495 patients submitted to the mhlw as the results of analyses of this all-case study, the mhlw has concluded that the all-case study was conducted properly and the necessary measures to ensure proper use of the product were sufficient to lift the condition.

eisai will continually strive to promote the proper use of inovelon and provide information about the product, thereby making further contributions to increase the benefits to patients and their families.

 

media inquiries:

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eisai co., ltd.

81-(0)3-3817-5120

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has received notification that aricept® (donepezil hydrochloride), a treatment for alzheimer’s disease and dementia with lewy bodies that was discovered and developed in-house, has been granted category 2* status based on the results of a reexamination of its efficacy, dosage and administration for the treatment of dementia with lewy bodies (dlb) in japan. in conjunction with this, eisai plans to promptly submit an application for a partial change to label regarding dosage and administration. the indication for dlb remains unchanged.

 

the indication of “suppression of progression of dementia symptoms in dlb” was approved in september 2014, primarily based on a phase ii study (study 431) and phase iii study (study 341) conducted by eisai on people living with dlb in japan. in accordance with the condition for the approval of this indication, “a clinical trial to verify the efficacy and safety of the drug in patients with dlb should be conducted and the results of the trials and analyses should be submitted promptly after completion,” eisai conducted a post-marketing clinical study (study 419) to evaluate the efficacy and safety of the drug in patients with dlb.

 

the results of study 419 did not show a statistically significant difference between the placebo group and the aricept group in the primary endpoint of global function (cibic-plus** comprehensive assessment), but the re-examination based on post-marketing studies, including the results of study 419, stated that “at present, the evaluation of clinical function in dlb using cibic-plus is not always sufficiently established as an evaluation method, and it is difficult to comprehensively evaluate the efficacy of this drug for dlb, although efficacy was seen in some patients. on the other hand, treatment with this drug showed a trend toward improvement in cognitive function (mmse***), and this result is consistent with the results of the clinical trial at the time of approval of the drug. since there are a certain number of patients who can be expected to benefit from the administration of this drug, it was concluded that the efficacy should be evaluated after the start of administration, and administration should only continue if efficacy is confirmed.”

therefore, it was concluded that the approved label (dose and administration) and package insert should be appropriately revised (category 2).

the condition of the approval was lifted as of the date of receipt of the reexamination results.

 

along with this prompt application for a partial change to label regarding dosage and administration for the dlb indication, eisai will place the highest priority on the provision of proper use and safety information for this drug, and will make continued contributions to address the diversified needs of, and increase the benefits provided to people living with dlb and their families.

 

media inquiries:

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eisai co., ltd.

81-(0)3-3817-5120

 

* category 2: partial changes in approval (modifications in approved items as directed)

** cibic-plus (the clinician’s interview-based impression of change plus caregiver input): a validated clinical instrument used to measure change in global function through an interview with patients and their caregivers. patients are evaluated by an assessor who is independent from the attending physician on a 7-point scale (very much improved, much improved, minimally improved, no change, minimally worse, much worse and very much worse) in four major categories: general, mental/cognitive state, behavior, and activities of daily living.

*** mmse (mini-mental state examination): a method for assessing cognitive function. comprised of the categories orientation, memorization, attention, calculation, recent and distant memory, comprehension, reading and writing, as well as design. test scores range from 30 (normal) to 0 (severely impaired).

to strengthen its research and development function for injectable drug formulations

 

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that, as part of the strategic investment towards the realization of its medium-term business plan “eway future & beyond”, it has completed construction of the new injection/research building “eisai medicine innovation technology solutions” (“emits”) at the kawashima industrial park located in gifu prefecture, japan.

(external view of emits)

emits will be eisai’s global base for formulation and modality research. in recent years, eisai’s drug discovery targets have expanded to include modalities such as antibodies, antibody drug conjugates (adcs), and nucleic acid drugs, in addition to conventional small molecule compounds. at emits, eisai will strengthen its injectable drug formulation development research function and drug delivery system (dds) development function, including liposomal and lipid nanoparticle formulations, and address the development of various modalities. the following initiatives will be implemented.

  • elevating the quality and speed of formulation process research through introduction of a state-of-the-art manufacturing data management system and utilization of ai
  • installation of facilities that also enable the manufacturing of clinical trial materials in order to manufacture investigational injection drugs in-house
  • introduction of rapid microbial testing methods for advanced microbiological control and sterility assurance
  • enhancing collaboration with the creation of flexible space that can also be used for collaborative research with external partners and technologies

through these efforts, eisai aims to elevate the quality of the technology and knowledge of its formulation research function, and to become a base for disseminating innovation, technology, and solutions relating to formulations. the aggregate investment in the construction of emits is approximately 10 billion japanese yen.

 

the kawashima industrial park is eisai’s global pharmaceutical manufacturing base, at which eisai has made a comprehensive framework comprising all steps from formulation research to formulation manufacturing. through the construction of emits, eisai aims to elevate the quality of its formulation research and formulation manufacturing, accelerate medicine creation activities, and ultimately further its contribution to improving the benefits of patients and their families.

 

media inquiries:

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eisai co., ltd.

81-(0)3-3817-5120

· all key secondary endpoints also met, demonstrating highly statistically significant results

· profile of amyloid-related imaging abnormalities (aria) incidence was within expectations

· eisai aims to file for traditional approval in the u.s., and to submit marketing authorization applications in japan and europe by the end of eisai fy2022, which ends on march 31, 2023

 

tokyo and cambridge, eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and biogen inc. (nasdaq: biib, corporate headquarters: cambridge, massachusetts, ceo: michel vounatsos, “biogen”) announced positive topline results from eisai’s large global phase 3 confirmatory clarity ad clinical trial of lecanemab (development code: ban2401), an investigational anti-amyloid beta (aβ) protofibril antibody for the treatment of mild cognitive impairment (mci) due to alzheimer’s disease (ad) and mild ad (collectively known as early ad) with confirmed presence of amyloid pathology in the brain. lecanemab met the primary endpoint (cdr-sb: clinical dementia rating-sum of boxes*) and all key secondary endpoints with highly statistically significant results. eisai will discuss this data with regulatory authorities in the u.s., japan and europe with the aim to file for traditional approval in the us and for marketing authorization applications in japan and europe by the end of eisai’s fy2022, which ends march 31, 2023. additionally, eisai will present the clarity ad study results on november 29, 2022, at the clinical trials on alzheimer’s congress (ctad), and publish the findings in a peer-reviewed medical journal.

 

* cdr-sb is a numeric scale used to quantify the various severity of symptoms of dementia. based on interviews of people living with ad and family/caregivers, qualified healthcare professionals assess cognitive and functional performance in six areas: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. the total score of the six areas is the score of cdr-sb, and cdr-sb is also used as an appropriate item for evaluating the effectiveness of therapeutic drugs targeting the early stages of ad.

 

lecanemab treatment met the primary endpoint and reduced clinical decline on the global cognitive and functional scale, cdr-sb, compared with placebo at 18 months by 27%, which represents a treatment difference in the score change of -0.45 (p=0.00005) in the analysis of intent-to-treat (itt) population. starting as early as six months, across all time points, the treatment showed highly statistically significant changes in cdr-sb from baseline compared to placebo (all p-values are less than 0.01). all key secondary endpoints were also met with highly statistically significant results compared with placebo (p<0.01). key secondary endpoints were the change from baseline at 18 months compared with placebo of treatment in amyloid levels in the brain measured by amyloid positron emission tomography (pet), the ad assessment scale-cognitive subscale14 (adas-cog14), ad composite score (adcoms) and the ad cooperative study-activities of daily living scale for mild cognitive impairment (adcs mci-adl).

 

the incidence of amyloid-related imaging abnormalities-edema/effusion (aria-e), an adverse event associated with anti-amyloid antibodies, was 12.5% in the lecanemab group and 1.7% in the placebo group. the incidence of symptomatic aria-e was 2.8% in the lecanemab group and 0.0% in the placebo group. the aria-h (aria cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis) rate was 17.0% in the lecanemab group and 8.7% in the placebo group. the incidence of symptomatic aria-h was 0.7% in the lecanemab group and 0.2% in the placebo group. there was no imbalance in isolated aria-h (i.e., aria-h in patients who did not also experience aria-e) between lecanemab (8.8%) and placebo (7.6%). the total incidence of aria (aria-e and/or aria-h) was 21.3% in the lecanemab group and 9.3% in the placebo group. overall, lecanemab’s aria incidence profile was within expectations.

 

clarity ad was a global confirmatory phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early ad. the treatment group was administered a dosage of 10 mg/kg bi-weekly of lecanemab, with participants allocated in a 1:1 ratio to receive either placebo or lecanemab. the baseline characteristics of both placebo and lecanemab groups are similar and well balanced. eligibility criteria allowed patients with a broad range of comorbidities/comedications: hypertension, diabetes, heart disease, obesity, renal disease and anti-coagulants, etc. eisai’s recruitment strategy for the clarity ad clinical trial ensured greater inclusion of ethnic and racial populations in the u.s., resulting in approximately 25% of the total u.s. enrollment including hispanic and african american persons living with early ad. due to the inclusive eligibility criteria and the successful recruitment of diverse ethnic and racial populations in the u.s., clarity ad’s population is generally comparable to the country’s medicare population.

 

“since eisai launched aricept in the u.s. and japan in the late 1990s and obtained its approval in over 100 countries, eisai has provided the drug to people living with dementia while building empathy for them and their families through disease education efforts and community involvement. the positive result of the lecanemab, an anti-aβ protofibril antibody, pivotal study after almost 25 years since aricept’s launch is an important milestone for eisai in fulfilling our mission to meet the expectations of the alzheimer’s disease community. alzheimer’s disease not only presents a great challenge for patients and their families, but it also negatively impacts society, including decreased productivity, increased social costs and disease-related anxiety. we believe that helping to alleviate these burdens will positively impact society as a whole,” said haruo naito, chief executive officer at eisai. “additionally, the lecanemab clarity ad study results prove the amyloid hypothesis, in which the abnormal accumulation of aβ in the brain is one of the main causes of alzheimer’s disease, when targeted with a protofibril-binding therapy. eisai believes these findings will create new horizons in the diagnosis and treatment of alzheimer’s disease as well as further activate innovation for new treatment options. the successful results of the clarity ad clinical trial would not be possible without the truly inspiring dedication of the study’s participants, their families and caregivers and the clinical investigators around the world. we thank all the people involved in the study for their invaluable contributions.”

 

“today’s announcement gives patients and their families hope that lecanemab, if approved, can potentially slow the progression of alzheimer’s disease, and provide a clinically meaningful impact on cognition and function,” said michel vounatsos, chief executive officer at biogen. “importantly, the study shows that removal of aggregated amyloid beta in the brain is associated with a slowing of disease in patients at the early stage of the disease. we want to thank the many patients who participated in this groundbreaking global study and want to acknowledge the clinical investigators who worked tirelessly to increase the enrollment of traditionally underrepresented populations. as pioneers in neuroscience, we believe defeating this disease will require multiple approaches and treatment options, and we look forward to continuing the discussion about the significance of these findings with the patient, scientific, and medical communities.”

 

in july 2022, the u.s. food and drug administration (fda) accepted eisai’s biologics license application (bla) for lecanemab under the accelerated approval pathway and granted priority review. the prescription drugs user fee act action date (pdufa) is set for january 6, 2023. the fda has agreed that the results of clarity ad can serve as the confirmatory study to verify the clinical benefit of lecanemab. in an effort to secure traditional fda approval for lecanemab as soon as possible, eisai submitted the bla through the fda’s accelerated approval pathway so that the agency could complete its review of all lecanemab data with the exception of the data from the confirmatory clarity ad study.

 

in march 2022, eisai began submitting application data, with the exception of clarity ad data, to japan’s pharmaceuticals and medical devices agency (pmda) under the prior assessment consultation system with the aim of obtaining early approval for lecanemab so that people living with early ad may have access to the therapy as soon as possible.

 

eisai serves as the lead of lecanemab development and regulatory submissions globally with both eisai and biogen co-commercializing and co-promoting the product and eisai having final decision-making authority.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and nippon medac co., ltd. (headquarters: tokyo, ceo: hirohisa iriyama, “nippon medac”), a subsidiary of medac gesellschaft für klinische spezialpräparate mbh (headquarters: germany) announced today that they have obtained manufacturing and marketing approval from the japanese ministry of health, labour and welfare for the indication of the anti-rheumatic agent “metoject® subcutaneous injection 7.5mg syringe 0.15ml, 10mg syringe 0.20ml, 12.5mg syringe 0.25ml and 15mg syringe 0.30ml” (methotrexate, “mtx”) for the treatment of rheumatoid arthritis. metoject will be the first self-administrable mtx subcutaneous injection formulation for rheumatoid arthritis in japan. based on the license agreement signed by eisai and medac gmbh in may 2019, nippon medac will hold the marketing authorization of metoject, while eisai will be responsible for product distribution of metoject in japan.

the approval is based on the results of a phase iii clinical trial (mc-mtx.17/ra) conducted in japan by nippon medac to compare the efficacy and safety of metoject with that of oral mtx, which consisted of a double-blind phase and an extension phase. in the double-blind phase of this trial, 102 rheumatoid arthritis patients who had not been treated with mtx received either 7.5 mg/week of metoject or 8 mg/week of oral mtx for 12 weeks in repeated doses. the primary endpoint of acr20 response* at 12 weeks was 59.6% in the metoject group versus 51.0% in the oral mtx group, indicating comparable efficacy. the adverse drug reaction incidence rates in this trial were 25.0% in the metoject group and 34.0% in the oral mtx group. in the double-blind phase, the most common adverse drug reactions (incidence 5% and higher) were stomatitis (5.8%) in the metoject group, and nausea (12.0%) and stomatitis (6.0%) in the oral mtx group.

it is reported that there are approximately 700,000 – 800,000 rheumatoid arthritis patients in japan1. mtx is used as the first-line option for the treatment of rheumatic arthritis, but only the oral formulation is available in japan. eisai and nippon medac will provide a self-administrable subcutaneous injection as a new treatment option for rheumatoid arthritis patients in japan as soon as possible, and will make further contributions to address the diversified needs of, and increase the benefits provided to, rheumatoid arthritis patients.

 

* acr20 is a criterion developed by the american college of rheumatology that measures improvement in clinical symptoms of rheumatoid arthritis. it expresses the percentage of patients who demonstrated a 20% or greater improvement in tender and swollen joint counts and at least three of the following five disease activity variables: patient assessment of pain; patient assessment of global disease activity; physician assessment of global disease activity; patient assessment of physical function; and chronic response protein or erythrocyte sedimentation rate concentrations.

 

 

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nippon medac co., ltd.

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findings to be featured in a late-breaking proffered paper session at european society for medical oncology (esmo) congress 2022

 

tokyo and rahway, n.j., september 12, 2022 – eisai (headquarters: tokyo, ceo: haruo naito, “eisai”) and merck & co., inc., rahway, nj, usa (known as msd outside of the united states and canada) today announced the first presentation of results from the final analysis of the phase 3 leap-002 trial investigating lenvima®, the orally available multiple receptor tyrosine kinase inhibitor discovered by eisai, plus keytruda®, the anti-pd-1 therapy from merck & co., inc., rahway, nj, usa versus lenvima monotherapy, as a first-line treatment for patients with unresectable hepatocellular carcinoma (uhcc). results are being presented during a proffered paper session at the european society for medical oncology (esmo) congress 2022, being held in paris, france and virtually from sept. 9-13 (abstract #lba34).

in the final analysis of the trial, there was a trend toward improvement for one of the study’s dual primary endpoints, overall survival (os), for patients treated with lenvima plus keytruda versus lenvima monotherapy; however, the results did not meet statistical significance per the pre-specified statistical plan (hr=0.84 [95% ci: 0.71-1.00]; p=0.0227). the median os was 21.2 months (95% ci: 19.0-23.6) for lenvima plus keytruda and 19.0 months (95% ci: 17.2-21.7) for lenvima monotherapy. additionally, treatment with lenvima plus keytruda resulted in a trend toward improvement in the trial’s other dual primary endpoint of progression-free survival (pfs) versus lenvima monotherapy; however, the results did not meet the pre-specified threshold at the first interim analysis for statistical significance (hr=0.87 [95% ci: 0.73-1.02]; p=0.0466).

 

“the leap-002 trial reflects our research strategy to build on evolving standards of care to further improve outcomes for more people with unresectable hepatocellular carcinoma,” said dr. gregory lubiniecki, vice president, global clinical development, merck & co., inc., rahway, nj, usa research laboratories. “the median overall survival of 21.2 months seen with keytruda plus lenvima provides critical insights for further research into the potential role of this combination.”

“while the outcome is not what we had hoped, it is important for us to see that patients in the trial treated with lenvima monotherapy had a median overall survival of 19.0 months,” said corina dutcus, m.d., senior vice president, clinical research, oncology at eisai inc. “findings from the leap-002 trial will not only help advance our understanding and application of lenvima plus keytruda across our clinical development program but will also provide physicians with additional information on lenvima monotherapy’s use in unresectable hepatocellular carcinoma, where it is currently approved as a treatment option in multiple regions around the world, including the u.s., the european union (eu), japan and china.”

lenvima monotherapy is approved for the first-line treatment of patients with uhcc in the u.s., the eu and china and for patients with uhcc in japan. the approval of lenvima was based on results of the phase 3 reflect trial, which evaluated the efficacy and safety of lenvima versus sorafenib for the first-line treatment of patients with uhcc.

lenvima (marketed as kisplyx® for renal cell carcinoma [rcc] in the eu) plus keytruda is approved in the u.s., the eu and japan for the treatment of certain types of advanced endometrial carcinoma and advanced rcc. eisai and merck & co., inc., rahway, nj, usa are studying the lenvima plus keytruda combination through the leap (lenvatinib and pembrolizumab) clinical program in multiple tumor types, including but not limited to endometrial carcinoma, hcc, melanoma, non-small cell lung cancer, rcc, head and neck cancer, colorectal cancer, gastric cancer and esophageal cancer, across more than 15 clinical trials.

 

leap-002 study design and final analysis results (abstract #lba34)

leap-002 is a multicenter, randomized, double-blinded, active-controlled phase 3 trial (clinicaltrials.gov, ) evaluating lenvima plus keytruda versus lenvima monotherapy for the first-line treatment of adult patients with uhcc. patients were randomized 1:1 to receive lenvima (12 mg orally once daily [for patients with screening body weight of at least 60 kg] or 8 mg orally once daily [for patients with screening body weight less than 60 kg]) plus keytruda (200 mg intravenously [iv] on day 1 of each three-week cycle); or lenvima (12 mg orally once daily [for patients with screening body weight of at least 60 kg] or 8 mg orally once daily [for patients with screening body weight less than 60 kg]) plus saline placebo (iv administered on day 1 of each three-week cycle). lenvima was administered until progressive disease or unacceptable toxicity. keytruda/placebo was administered for up to 35 cycles (approximately two years).

the dual primary endpoints were pfs, as assessed by blinded independent central review (bicr) per response evaluation criteria in solid tumors version 1.1 (recist v1.1; recist v1.1 has been modified for this study to follow a maximum of 10 target lesions in total and a maximum of five target lesions per organ), and os. objective response rate (orr), as assessed by bicr per recist v1.1, was a key secondary endpoint. the trial was designed with two interim analyses and a final analysis for os. pre-specified efficacy boundaries were one-sided p=0.002 for pfs at interim analysis 1 and p=0.0185 for os at the final analysis.

as of the data cut-off for the final analysis (june 21, 2022), a total of 794 patients were enrolled and treated, with a median follow-up of 32.1 months (range, 25.8-41.1). a total of 534 os events had occurred, with 36 patients (9.1%) in the combination arm and 24 patients (6.1%) in the lenvima monotherapy arm remaining on study treatment.

the median os was 21.2 months (95% ci: 19.0-23.6) for lenvima plus keytruda versus 19.0 months (95% ci: 17.2-21.7) for lenvima monotherapy at the final analysis. the median pfs was 8.2 months (95% ci, 6.4-8.4) for lenvima plus keytruda versus 8.0 months (95% ci: 6.3-8.2) for lenvima monotherapy at the first interim analysis and 8.2 months (95% ci: 6.3-8.3) versus 8.1 months (95% ci: 6.3-8.3), respectively, at the final analysis. the orr was 26.1% (95% ci: 21.8-30.7) for lenvima plus keytruda versus 17.5% (95% ci: 13.9-21.6) for lenvima monotherapy at the final analysis. median duration of response was 16.6 months (range, 2.0 to 33.6 ) in the keytruda plus lenvima arm versus 10.4 months (range, 1.9 to 35.1 ) in the lenvima monotherapy arm at the final analysis.

the safety profile of lenvima plus keytruda was consistent with previously reported data on the combination. grade 3-4 treatment-related adverse events (traes) occurred in 61.5% of patients treated with lenvima plus keytruda versus 56.7% of patients treated with lenvima monotherapy. grade 5 traes occurred in 1.0% of patients treated with lenvima plus keytruda versus 0.8% of patients treated with lenvima monotherapy. in patients treated with lenvima plus keytruda, the five most common traes of any grade were hypertension (43.3%), diarrhea (40.3%), hypothyroidism (40.0%), palmar-plantar erythrodysesthesia (ppe) syndrome (33.2%) and proteinuria (30.6%). in patients treated with lenvima monotherapy, the five most common traes of any grade were hypertension (46.8%), hypothyroidism (35.7%), proteinuria (34.9%), diarrhea (33.9%) and ppe syndrome (30.6%). post-study systematic anti-cancer treatments were given for 44.1% of patients receiving lenvima plus keytruda versus 52.1% of those receiving lenvima monotherapy.

 

 

eisai co., ltd.

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merck & co., inc., kenilworth, n.j., u.s.a.

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nikki sullivan: 1-(718) 644-0730

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analysis evaluates efficacy of eribulin in metastatic her2-low breast cancer across three clinical studies

 

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today results from a post hoc analysis of three randomized, pivotal, phase 3 studies (embrace trial/study 305, study 301 and study304) evaluating the efficacy of eribulin mesylate (marketed as halaven®) versus other chemotherapies (treatment of physician’s choice [tpc], capecitabine, and vinorelbine, respectively) in patients living with metastatic breast cancer (mbc) whose tumors have low or no her2 expression. these data were presented as a poster (presentation: #259p) at the european society for medical oncology (esmo) annual meeting (#esmo22), held virtually and in-person in paris, france from september 9-13, 2022.

the her2-low breast cancer subtype is a newly defined subset consisting of tumors that would have previously been considered her2-negative based on an immunohistochemistry (ihc) assay and an in situ hybridization (ish) assay. her2-low tumors express low amounts of the her2 protein, but not enough to be considered her2-positive. her2-low is defined as an ihc of 1 or 2 with a negative ish. of the approximate 288,000 new cases of female breast cancer expected to be diagnosed in the u.s. in 2022,1 it is estimated that approximately 80-85% of patients would previously have been considered to have the her2-negative subtype. of those patients, about 60% would now be considered to have the her2-low subtype.2

“in this post-hoc analysis, the outcomes seen in mbc patients whose tumors are considered her2-low are consistent with the results of the three pivotal phase 3 clinical trials,” said dr. takashi owa, chief scientific officer, senior vice president, eisai co., ltd. “as the oncology community’s understanding of mbc continues to evolve, it’s important that we continue to evaluate the role of existing therapies in new contexts to contribute to the body of knowledge that is available to health care professionals.”

data from the post hoc analysis

the post hoc analysis included data from three trials — eribulin vs. tpc (, embrace trial/study 305), eribulin vs. capecitabine (, study 301), and eribulin vs. vinorelbine (, study 304) in patients with locally recurrent or mbc who had prior lines of chemotherapy treatments (≤2 for study 301; 2-5 for study 304 and embrace trial/study 305) including an anthracycline and a taxane. a total of 1,589 eligible patients were enrolled in the embrace trial/study 305, study 301 and study 304, and baseline characteristics were generally balanced between treatment arms in all studies.

median overall survival (os), median progression free survival (pfs) and objective response rate (orr) were analyzed. pfs and orr were measured per response evaluation criteria in solid tumors version (recist) (v1.0 for embrace trial/study 305 and study 301; v1.1 for study 304) by independent imaging review. orr was measured in evaluable patients (embrace trial/study 305) and in the intent-to-treat population (study 301 and study 304).

in the post hoc analysis, os, pfs, and orr among patients with her2-low or her2-negative status were generally similar to those of the eribulin treatment arms overall in each of the embrace trial/study 305, study 301 and study 304.3,4,5 efficacy results for patients with her2-low and her2-negative status across all three studies are summarized in the table below:

 

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eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has filed a supplementary new drug application in japan for its in-house discovered antiepileptic drug (aed) fycompa® (perampanel) seeking approval for an injection formulation as a new route of administration.

fycompa is a first-in-class aed discovered at eisai’s tsukuba research laboratories. the agent is a highly selective, noncompetitive ampa receptor antagonist that is postulated to reduce neuronal hyper-excitation associated with seizures by targeting glutamate activity at ampa receptors on postsynaptic membranes. two oral formulations of fycompa are available in japan: a tablet and a fine granule formulation. due to concern about the risks associated with interruption of administration when the drug cannot be taken orally temporarily, such as during surgery, it is suggested that epilepsy patients should continue treatment other than via oral administration. the injection formulation was developed as a non-oral administration route to meet such medical needs, and its bioequivalence to the tablet formulation, as well as the confirmation of the safety and tolerability of the injection formulation when administered as an alternative therapy to the tablet, lead to this application. the addition of an injection formulation of fycompa, the only ampa receptor antagonist-based aed, to the product lineup is expected to provide a new treatment option for a broader range of patients.

it is estimated that there are approximately 1 million patients with epilepsy in japan, and although onset occurs at any age, it is most common in people aged 18 and younger, and the elderly.

eisai considers neurology, including epilepsy, a therapeutic area of focus and is in continued pursuit of our mission to provide “seizure freedom” to a greater number of patients living with epilepsy. eisai seeks to address the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.

 

media inquiries:

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eisai co., ltd.

81-(0)3-3817-5120

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that its u.s. subsidiary eisai inc. has entered into a memorandum of understanding with c2n diagnostics (“c2n”) that will seek to build awareness about how blood-based assays in the diagnosis for people living with cognitive impairment, including alzheimer’s disease (ad), may help patients receive a timely diagnosis and appropriate treatment. collaborating with c2n, eisai inc. will work to build awareness and develop real-world evidence to support the use of blood-based assays in people living with cognitive impairment in clinical practice outside of clinical trial settings in the u.s. blood-based assays could result in the development of new standards in clinical care that may enable timely and accurate diagnoses for people living with cognitive impairment.

the number of people with dementia is growing substantially; more than 55 million people worldwide are living with dementia, and this number is expected to increase to 78 million by 2030.1 accurate diagnosis remains a barrier to early and proper care management; research reviews estimate that between 40 and 60 percent of adults with probable dementia are undiagnosed.2 importantly, blood-based assays may be able to help identify which patients may benefit from therapy, and therefore may help streamline care and reduce healthcare spending. early detection, diagnosis and treatment of dementia protects individuals against risks from delayed or missed diagnosis and allows individuals, their families and their caregivers to plan for the future as the condition progresses.2

the development and adoption of blood-based assays as simple diagnostic tools, in every day clinical practice is an important step in improving care for people in remote and underserved communities where access to the traditional diagnostic tools of positron emission tomography (pet) and lumbar punctures are not a viable option.

in collaboration with various partners, eisai will engage in practical application of simple and less invasive diagnostic technologies and diagnostics for dementia, including blood tests, and will work to improve the medical environment in which people with dementia can receive appropriate treatment, thereby contributing to relieving anxieties of people living with dementia and their families around the world.

 

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eisai co., ltd.

81-(0)3-3817-5120

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and lifenet insurance company (headquarters: tokyo, president: ryosuke mori, “lifenet”) announced today that they have entered into a capital and business alliance agreement to collaborate in dementia and other areas, with the aim of helping reduce the burden of medical and nursing care for people living in japan’s aging society.

new insurance products and services will be developed by mutually leveraging eisai’s wealth of experience and network in drug discovery and disease awareness activities in the field of dementia, which it has built up over many years, and lifenet’s know-how and technologies cultivated in insurance products and related services. furthermore, eisai and lifenet will promote the creation of healthcare solutions utilizing various data and customer touchpoint owned by both companies, and expand the ecosystem that contributes to solving social issues.

under the terms of the agreement, eisai will obtain lifenet common stock worth 300 million yen through market transaction.

under the medium-term business plan“eway future & beyond”, which began in april 2021, eisai is expanding its main role in healthcare, that is, we should contribute not only to people in the medical domain but also to people in the daily living domain. eisai aim’s to evolve into a company that empowers them “to realize their fullest life” by creating solutions based on science and data in the fields with high unmet medical needs where eisai has the greatest strength, through an ecosystem developed in collaboration with other industries. this alliance will accelerate the building of a dementia ecosystem that contributes through prevention, treatment, and aftercare in a comprehensive manner.

lifenet has worked with other industry partners to provide products and services that meet the needs of the times. through this alliance, as stated in , lifenet will continue providing health and wellness tips beyond the framework of life insurance to create value in our policyholders’ lives, while creating a precedent for future generations as to what life insurance is (and should be) all about.

eisai and lifenet will contribute to solving social issues through the creation of an ecosystem while pursuing the possibility of collaborations with other companies and organizations that support the objectives of the two companies’ activities.

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