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after four years of follow-up, lenvima plus keytruda reduced the risk of death by 21% versus sunitinib in the pivotal phase 3 clear (study 307)/keynote-581 trial
final results will be presented at asco 2023 in an oral abstract session

 

tokyo and rahway, n.j., may.26, 2023 – eisai (headquarters: tokyo, ceo: haruo naito) and merck & co., inc., rahway, nj, usa (known as msd outside of the united states and canada) today announced data from the final pre-specified overall survival (os) analysis of the pivotal phase 3 clear (study 307)/keynote-581 trial investigating lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by eisai, plus keytruda, merck’s anti-pd-1 therapy, for the first-line treatment of patients with advanced renal cell carcinoma (rcc). these data will be presented on monday, june 5 at 11:54 a.m. central daylight time during an oral abstract session at the 2023 american society of clinical oncology (asco) annual meeting (abstract #4502).

after four years of follow-up, lenvima plus keytruda maintained a clinically meaningful os benefit versus sunitinib, reducing the risk of death by 21% (hr=0.79 [95% ci, 0.63-0.99]). the 24- and 36-month estimated os rates were 80.4% and 66.4% for lenvima plus keytruda versus 69.6% and 60.2% for sunitinib, respectively. results from the final pre-specified os analysis were consistent with the superior results versus sunitinib from the primary os analysis of the clear/keynote-581 trial.

additionally, lenvima plus keytruda reduced the risk of disease progression or death by 53% (hr=0.47 [95% ci, 0.38-0.57]), with a median progression-free survival (pfs) of 23.9 months (95% ci, 20.8-27.7) for lenvima plus keytruda versus 9.2 months (95% ci, 6.0-11.0) for sunitinib; the objective response rate (orr) was 71.3% (95% ci, 66.6-76.0) with a complete response (cr) rate of 18.3% for lenvima plus keytruda versus an orr of 36.7% (95% ci, 31.7-41.7) with a cr rate of 4.8% for sunitinib.

there were no new safety signals and the safety profile at the final os analysis was consistent with the primary analysis. grade ≥3 treatment-related adverse events (trae) occurred in 74.1% of patients who received lenvima plus keytruda versus 60.3% of patients who received sunitinib. the six most common traes of any grade of patients in the lenvima plus keytruda arm were diarrhea (56.0%), hypertension (54.3%), hypothyroidism (44.9%), decreased appetite (35.5%), fatigue (34.1%) and stomatitis (32.7%). in the sunitinib arm, the six most common traes of any grade were diarrhea (45.3%), hypertension (40.3%), stomatitis (37.4%), palmar-plantar erythrodysesthesia (36.2%), fatigue (32.9%) and nausea (28.2%).

“lenvima plus keytruda continues to demonstrate durable clinical benefit as a first-line treatment for patients with advanced renal cell carcinoma, as shown by the clinically meaningful improvement in overall survival sustained with four years of follow up,” said dr. thomas hutson, do, pharm.d., facp, director of the urologic oncology program and co-chair of the urologic cancer research and treatment center, texas oncology at baylor sammons cancer center. “furthermore, these data also showed clinically meaningful improvements in median pfs and orr compared to sunitinib. these findings reinforce the important role of lenvima plus keytruda as a first-line standard of care treatment option for patients with advanced renal cell carcinoma.”

“long-term follow up data from the clear/keynote-581 trial show the responses to first-line use of keytruda plus lenvima were durable for many of these patients,” said dr. gregory lubiniecki, vice president, global clinical development, merck research laboratories. “through our joint clinical development program with eisai, we’re continuing to advance our research evaluating keytruda plus lenvima for other challenging cancers as we strive to help even more patients.”

“at the final pre-specified analysis, lenvima plus keytruda continued to demonstrate clinically meaningful efficacy across pfs, orr and os, providing patients and their physicians with new information about treating people living with advanced renal cell carcinoma,” said corina dutcus, m.d., senior vice president, clinical development, oncology at eisai inc. “these results are a testament to our steadfast commitment to people living with advanced cancers, and we are grateful for the support from the patients, families and healthcare provider community for their participation in this research.”

lenvima plus keytruda is approved in the u.s., the eu, japan and other countries for the treatment of advanced rcc and certain types of advanced endometrial carcinoma. lenvatinib is marketed as kisplyx® for advanced rcc in the eu. eisai and merck are studying the lenvima plus keytruda combination through the leap (lenvatinib and pembrolizumab) clinical program in various tumor types, including but not limited to endometrial carcinoma, hepatocellular carcinoma, non-small cell lung cancer, rcc, head and neck cancer, gastric cancer and esophageal cancer across multiple clinical trials.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) has announced that it will grant a total of 625 million yen to the global health innovative technology fund (“ghit fund”) to fund the third phase of its activities, which will take place in the five-year period from fy2023 to fy2027. the ghit fund is a public-private partnership, co-established in april 2013 by partners such as japanese pharmaceutical companies (including eisai), the japanese government, and the bill & melinda gates foundation, for the purpose of accelerating development of new medicines to cure infectious diseases in developing and emerging countries by facilitating collaboration between research organizations in japan and overseas. eisai has provided a total of 1 billion yen to the first phase (fy2013 – fy2017) and the second phase (fy2018 – fy2022) of the ghit fund.

in order to develop treatments for the numerous people suffering from infectious diseases such as neglected tropical diseases (ntds) and malaria in developing and emerging countries, there are disease-specific development and marketability issues to overcome. it is also necessary to establish local supply systems and help patients secure access to diagnosis and treatments. the key to overcoming these challenges are industry-government-academia partnerships which transcend the usual sector boundaries.

eisai considers making efforts to resolve the global issue of access to medicines to be its duty. under a public-private partnership including governments, international organizations, and private non-profit organizations, eisai has participated in 23 joint research projects to develop new medicines and vaccines for mycetoma, malaria and filariasis, with the support of the ghit fund.

eisai has conducted a phase ii clinical trial of its in-house developed agent e1224 (generic name: fosravuconazole) in sudan for the treatment of mycetoma in partnership with the non-profit organization drugs for neglected diseases initiative (dndi). eisai is also conducting a phase ii clinical trial of antimalarial agent sj733 in collaboration with the university of kentucky.

eisai considers efforts for improving access to medicines, such as the elimination of ntds and malaria, as activities aimed at creating long-term corporate value and social impact based on its corporate concept of human health care (hhc). we will continue to strengthen cooperation with our global partners and contribute to “relieving anxiety over health” and “reducing health disparities” for people at risk of infection with ntds and those suffering from theses diseases.

 

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

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today the presentation of research across various types of cancer from its oncology portfolio and pipeline during the 2023 american society of clinical oncology (asco) annual meeting (#asco23), which is taking place virtually and in-person in chicago, illinois from june 2 to 6.

notable research includes an oral presentation of results from the final pre-specified overall survival analysis of the pivotal phase 3 clear (study 307)/keynote-581 trial, which evaluated lenvatinib (lenvima®) plus pembrolizumab (keytruda®) versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (abstract #4502). a post hoc analysis from the reflect trial evaluating lenvatinib monotherapy versus sorafenib in the first-line treatment of patients with unresectable hepatocellular carcinoma (hcc) will also be shared in a poster presentation (abstract #4078).

“the outlook for advanced renal cell carcinoma has evolved in recent years, and the final analysis from the pivotal clear trial to be presented at asco represents another step forward for patients and an opportunity to provide their physicians with long-term data,” said dr. takashi owa, chief scientific officer, senior vice president, eisai co., ltd. “new data for lenvatinib and from our oncology pipeline showcase eisai’s continued commitment to driving innovation and exploring novel therapeutic modalities in our ambition to live out our human health care concept, our corporate mission to meet the needs of more people who face a cancer diagnosis.”

additional data from eisai’s pipeline include a poster presentation of findings from a phase 1b study of e7386, a creb-binding protein (cbp) / β-catenin interaction inhibitor, in combination with lenvatinib in patients with advanced hcc (abstract #4075), and the small cell lung cancer cohort of a phase 1b/2 trial evaluating e7389-lf, a new liposomal formulation of eribulin, in combination with nivolumab (abstract #8593). insights from preclinical testing of farletuzumab ecteribulin (fzec), formerly known as morab-202, and morab-109, antibody drug conjugates (adc), in rare gynecologic cancers will also be published online (abstract # e17634).

furthermore, bliss biopharmaceutical co., ltd. (blissbio) will present a poster at the conference with results from the first-in-human study of bb-1701, a her2-targeting adc (abstract #3029). eisai entered into a joint development agreement with blissbio for bb-1701 with option rights for a strategic collaboration in april 2023. a phase 1/2 clinical study of bb-1701 in the u.s. and china for her2-expressing solid tumors is currently underway.

this release discusses investigational compounds and investigational uses for fda-approved products. it is not intended to convey conclusions about efficacy and safety. there is no guarantee that any investigational compounds or investigational uses of fda-approved products will successfully complete clinical development or gain fda approval.

the full list of presentations is included below. these abstracts will be made available on thursday, may 25, 2023 at 4:00 pm central daylight time (cdt).

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

tokyo and cambridge, mass., may 22, 2023 – eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and biogen inc. (nasdaq: biib, corporate headquarters: cambridge, massachusetts, ceo: christopher a. viehbacher, “biogen”) announced today that eisai has submitted a marketing authorization application (maa) for lecanemab, an investigational anti-amyloid beta (aβ) protofibril antibody, for the treatment of early alzheimer’s disease (mild cognitive impairment due to alzheimer’s disease (ad) and mild ad dementia) with confirmed amyloid pathology in the brain, to the uk medicines and healthcare products regulatory agency (mhra) in great britain. lecanemab has been designated by the mhra for the innovative licensing and access pathway (ilap).

the maa is based on the results of the confirmatory phase iii clarity ad study and phase iib clinical study (study 201), which demonstrated that lecanemab treatment showed a reduction of clinical decline in early ad, and is subject to a validation to determine whether it will be accepted by the mhra. lecanemab selectively binds and eliminates soluble, toxic aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in ad. as such, lecanemab may have the potential to have an effect on disease pathology and the progression of the disease. the clarity ad study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.

 

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.

tokyo and cambridge, mass., may 16, 2023 – eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) and biogen inc. (nasdaq: biib, corporate headquarters: cambridge, massachusetts, ceo: christopher a. viehbacher, “biogen”) announced today that health canada has accepted a new drug submission (nds) for lecanemab (brand name in the u.s.: leqembi™), an investigational anti-amyloid beta (aβ) protofibril* antibody, for the treatment of early alzheimer’s disease (mild cognitive impairment due to alzheimer’s disease (ad) and mild ad dementia) with confirmed amyloid pathology in the brain.

the nds is based on the results of the phase iii clarity ad study and phase iib clinical study (study 201), which demonstrated the lecanemab treatment showed a reduction of clinical decline in early ad. lecanemab selectively binds and eliminates soluble, toxic aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in ad. as such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. the clarity ad study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results. in november 2022, the results of the clarity ad study were presented at , and simultaneously published in , a peer-reviewed medical journal.

lecanemab was approved under the accelerated approval pathway in the u.s. and was launched in the u.s. on january 18, 2023. the accelerated approval was based on phase ii data that demonstrated that lecanemab reduced the accumulation of aβ plaque in the brain, a defining feature of ad, and its continued approval may be contingent upon verification of lecanemab’s clinical benefit in a confirmatory trial. the u.s. food and drug administration (fda) determined that the results of clarity ad can serve as the confirmatory study to verify the clinical benefit of lecanemab.

in the u.s., eisai submitted a supplemental biologics license application (sbla) to the fda for approval under the traditional pathway on january 6, 2023. on march 3, 2023, the fda accepted eisai’s sbla based on the clarity ad clinical data, and the lecanemab application has been granted priority review, with a prescription drug user fee act (pdufa) action date of july 6, 2023. the fda is planning to hold an advisory committee to discuss this application on june 9, 2023. in japan, eisai submitted an application for manufacturing and marketing approval to the pharmaceuticals and medical devices agency (pmda) on january 16, 2023. priority review was granted by the ministry of health, labour and welfare (mhlw) on january 26, 2023. eisai utilized the pmda’s prior assessment consultation system, with the aim of shortening the review period for lecanemab. in europe, eisai submitted a marketing authorization application (maa) to the european medicines agency (ema) on january 9, 2023, which was accepted on january 26, 2023. in china, eisai initiated submission of data for a bla to the national medical products administration (nmpa) of china in december 2022, and priority review was granted on february 27, 2023.

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.

*   protofibrils are large aβ aggregated soluble species of 75-5000 kd.1

söderberg, l., johannesson, m., nygren, p. et al. lecanemab, aducanumab, and gantenerumab – binding profiles to different forms of amyloid-beta might explain efficacy and side effects in clinical trials for alzheimer’s disease. neurotherapeutics (2022). . accessed february 9, 2023

feng yanhui, president of eisai china, visited sinopharm holding henan co., ltd for business research, accompanied by li yunlong, vp of eisai china, zhao jianjun, director of north china access department, and xia ruiying, manger of north china access department in eisai china. chen zhanyu, vice president of sinopharm holding and chairman of sinopharm holding henan, zhang zhaohui, general manager of sinopharm holding henan, xu hai, deputy general manager of sinopharm holding global procurement and supply chain service center , li jie, assistant general manager of sinopharm holding henan, and yang fan, director of supply chain business development department of sinopharm holding received feng yanhui and her delegation.

the two sides conducted a business seminar in the company’s conference room. li jie briefly introduced the development of sinopharm holding henan and the cooperation between sinopharm holding henan and eisai china. leaders from both sides had an in-depth discussion on the cooperation in medical, retail and other business modes, and pointed out the direction for the future cooperation between the two sides.

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today that it has entered into a joint development agreement with bliss biopharmaceutical (hangzhou) co., ltd. (headquarters: zhejiang province, china, “blissbio”), for bb-1701, an antibody-drug conjugate (adc) with option rights for a strategic collaboration.

bb-1701 is an adc that is composed of eisai’s in-house developed anticancer agent eribulin, and anti-her2 antibody using a linker, and is expected to have anti-tumor effects on breast, lung and other solid tumors that express her2. the linker-payload, which uses eribulin as a payload, is a proprietary technology platform developed by eisai’s u.s. research base exton site, and eisai is investigating the possibilities of using this platform to link to various antibodies. under a license agreement signed by the two companies in 2018, eisai has granted blissbio global exclusive development rights for several adcs to use eribulin as the payload. based on the status of the phase i/ii clinical trials of bb-1701 currently being conducted by blissbio, the both companies have decided to co-develop this drug.

under the terms of the joint development agreement, eisai will make upfront and development milestone payments to blissbio, conduct a phase ii clinical trial in breast cancer, and obtain option rights to develop and commercialize bb-1701 globally, excluding greater china (china, hong kong, macau, taiwan). if eisai exercises the option rights, an additional upfront payment will be made to blissbio, as well as development and regulatory milestone payments, sales milestone payments and a certain amount of royalties on sales revenue of bb-1701 after the launch. if all development, regulatory and sales milestones are achieved, up to a total of $2 billion usd will be paid.

“bb-1701 is characterized by its payload of eribulin, which is a product of our modern synthetic organic chemistry that has already made contributions to patients with breast cancer and soft tissue sarcoma,” said dr. takashi owa, chief scientific officer, senior vice president, eisai co., ltd. “our collaboration with blissbio will accelerate the development of bb-1701 with the goal of bringing a new treatment option to patients globally.”

 

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

the “national kickoff meeting of lecturer group on gastrointestinal mucosa ” was grandly held on april 14th at the inner mongolia building in beijing, accompanied by the 2023 beijing union medical college international digestive disease forum.

professor li jingnan, head of the gastrointestinal hormone and mucosal barrier group of division of gastroenterology in the chinese society of medical sciences, said in his speech at the conference that, eisai china and the group had worked closely together to promote academic development in the field of gi mucosa, and thanked eisai china for its strong support to the group, and that the establishment of the lecturer group would assist the group in raising doctors’ awareness of gi mucosa protection.

more than 20 mucosa-related experts from different provinces and cities were announced as lecturers for this “kick-off meeting”, including professor li jingnan from peking union medical college hospital, professor wang xiaozhong from union hospital of fujian medical university, professor wang jiangbin from china-japan friendship hospital of jilin university, professor dong weiguo from people’s hospital of wuhan university, professor wang liangjing from the second hospital of zhejiang university medical college, professor wang fangyu from the general hospital of the eastern war zone of the chinese people’s liberation army, professor zeng zhirong from the first hospital of sun yat-sen university, professor miao yinglei from the first affiliated hospital of kunming medical university, professor jiang haixing from the first affiliated hospital of guangxi medical university, and professor jiang haixing from the first hospital of huazhong university of science and technology, professor jiang haixing from the first affiliated hospital of guangxi medical university, professor lin rong from union hospital of tongji medical college of huazhong university of science and technology, professor zhang kaiguang from the first affiliated hospital of china university of science and technology, professor zuo xiuli from qilu hospital of shandong university, professor wu hao from west china hospital of sichuan university, professor liu caifang from people’s hospital of hebei province, professor zhang chuan from tong ren hospital of beijing, professor xu guifang from gulou hospital of nanjing university school of medicine.

during the meeting, the experts discussed the work plan of gastrointestinal mucosa related work in 2023. in particular, it should be noted that the case directions and criteria for the collection of cases related to gi mucosal injury were clarified, including the collection of cases of drug-derived gi injury, small bowel mucosal injury, ulcers, colonic mucosal lesions, etc. selected cases are planned to be published in the chinese journal of gastroenterology supplement, which is the result of a win-win collaboration between eisai and the group.

the establishment of the gi mucosa lecturer group and the conduct of lecture tours will provide high-quality academic content for doctors and raise their awareness of gi mucosa protection, benefiting a wider range of digestive patients.

as a global drug discovery center aiming for connecting human and human, and data, and the world

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) today announced the completion of a major renovation of its tsukuba research laboratories (ibaraki, japan), which is a part of strategic investment to execute eisai’s medium-term business plan “eway future & beyond”.

 

eisai implements research and development activities under the dhbl (deep human biology learning) drug discovery and development system in our efforts to create new drugs based on innovative and efficient next-generation drug discovery concepts. for this purpose, we recognize diseases as disease continuum to redefine their concepts through comprehensive analysis on genomic, pathophysiological and clinical information associated with underlying causes of disease in order to enhance our understanding on human biology by acquiring data leading to next drug discovery with information, such as biomarkers and imaging data from patients on our drugs. tsukuba research laboratories is positioned as a core facility in the dhbl drug discovery and development system. this renovation seeks to accelerate knowledge circulation by connecting each researcher with patients, other members within the laboratories, other research sites across the world, and external researchers based on our key concept “human connected laboratories: laboratories connecting human and human, and data, and the world.” total investment on this major renovation was 8.5 billion yen.

 

main idea of this major renovation

[designs to enhancing connection with patients]

in the eisai group, all employees around the world use 1% of their total business hours to interact with patients (socialization) to understand their thoughts and feelings. accordingly, we have been working on the initiatives (hhc activities) to lead value creation for patients. to enhance the opportunities for closer interaction with people outside the company, such as further socialization with patients, at tsukuba research laboratories, a traffic line from the front gate through the main building lobby to the courtyard is placed as interactive zone to enable various communications.

 

[realizing connections between researchers and data driven drug discovery]

in favor of generating natural communication between researchers across different therapeutic areas on a daily basis, workspaces for biology researchers and data scientists are allocated on the same floor, and likewise workspaces for chemistry and pharmacokinetics/analytical researchers are placed on nearby floors to foster new connections and knowledge exchange. further creative solutions are implemented in laboratories, including collective arrangement of structural openings and devices. these designs facilitate data driven drug discovery through knowledge exchange.

 

[knowledge circulation generated from links between buildings]

corridors linking multiple buildings embodying the concept of knowledge circulation are placed. a traffic line named “knowledge corridor” enables people to move all around the laboratory, with which research efficiency and convenience are considerably improved.

 

[meeting rooms value connection with the world]

each meeting room is equipped with an it environment that allows smooth communication with overseas offices, as well as systems able to deal with hybrid meeting which dominantly accepted in recent days.

 

eisai will accelerate the drug discovery activities under the dhbl drug discovery system in order to fulfill unmet medical needs, and in our efforts to further contribute to improve the benefits of patients and the people in the daily living domain.

 

media inquiries:

public relations department,

eisai co., ltd.

81-(0)3-3817-5120

[notes to editors]

1. outline of tsukuba research laboratories

location: 5-1-3 tokodai, tsukuba, ibaraki

groundbreaking of the renovation: december 2019

completion of the renovation: february 2023 (opening ceremony: 6 april 2023)

site area: 86,845.05 m2

building area: 65,110.78 m2

total investment on the renovation: 8.5 billion yen

 

an interactive zone for researchers and people outside company

 

a traffic line named “knowledge corridor”

 

a workplace for data scientists

eisai co., ltd. (headquarters: tokyo, ceo: haruo naito, “eisai”) announced today the presentation of two abstracts at the society of gynecologic oncology (sgo) 2023 annual meeting on women’s cancer (#sgomtg), which is taking place in-person in tampa, florida and virtually from march 25-28.

 

notable research to be featured in the scientific plenary ix: the best of the rest session includes a presentation of real-world outcomes and healthcare resource utilization in patients with recurrent or advanced endometrial carcinoma who were rechallenged with platinum chemotherapy in europe (abstract: #17). also to be presented are data from the leap (lenvatinib and pembrolizumab) clinical program analyzing tumor-response from the lenvatinib (lenvima®) plus pembrolizumab (keytruda®) arm of the pivotal phase 3 study 309/keynote-775 trial in patients with advanced endometrial carcinoma following at-least one prior platinum-based regimen in any setting (; abstract: #518).

 

“we look forward to sharing our data at this year’s sgo annual meeting, particularly a new study that will be presented in an oral scientific plenary session featuring real-world outcomes in patients with recurrent or advanced endometrial cancer who were rechallenged with platinum chemotherapy,” said dr. takashi owa, chief scientific officer, senior vice president, eisai co., ltd. “we believe this research is important to the healthcare providers and patients we aim to serve because it is essential to understand treatment dynamics and related outcomes in clinical practice. as a human health care company, we remain steadfast in our commitment to advance the science of cancer medicine through the generation of real-world evidence.”

 

in march 2018, eisai and merck & co., inc., rahway, nj, usa (known as msd outside of the united states and canada), through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib, both as monotherapy and in combination with merck’s anti-pd-1 therapy pembrolizumab. to date, more than 10 trials have been initiated under the leap clinical program, which is evaluating the combination across multiple tumor types.

 

this release discusses investigational compounds and investigational uses for fda-approved products. it is not intended to convey conclusions about efficacy and safety. there is no guarantee that any investigational compounds or investigational uses of fda-approved products will successfully complete clinical development or gain fda approval.

 

the full list of eisai presentations is included below. full abstracts will be posted the day of scheduled presentations.

 

 

media inquiries:

public relations department,

eisai co., ltd.

81-(0)3-3817-5120

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