WOODCLIFF LAKE - Eisai will present five abstracts across four tumor types at the Gastrointestinal Cancers Symposium (#GI21), which is being held virtually from January 15-17, 2021.

Investigational data on the lenvatinib plus pembrolizumab combination that will be presented includes results from the Phase 2 LEAP-005 trial (NCT03797326) evaluating multiple cohorts of patients with previously treated solid tumors, including: gastric cancer (Abstract #230), biliary tract cancers (Abstract #321) and colorectal cancer (Abstract #94).

Additional data to be presented include findings from a post-hoc analysis in patients with unresectable hepatocellular carcinoma (HCC) who progressed to Child-Pugh B liver function in the Phase 3 REFLECT trial (NCT01761266) evaluating lenvatinib (Abstract #298). Also, real-world effectiveness of lenvatinib monotherapy among unresectable HCC patients in the United States clinical practices will be presented (Abstract #273).

'These studies demonstrate our commitment to explore the therapeutic potential of lenvatinib-both as a monotherapy and investigational combination therapy-and continue to build evidence in clinical practice post approval-across advanced gastrointestinal cancers,' said Dr. Takashi Owa, Vice President, Chief Medicine Creation Officer and Chief Discovery Officer, Oncology Business Group at Eisai. 'As we continue to expand our research and knowledge in new cancer types, we aim to give patients and their families hope.'

In March 2018, Eisai and Merck (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 lenvatinib, both as monotherapy and in combination with Merck's anti-PD-1 therapy pembrolizumab. To date, 20 trials have been initiated under the LEAP (LEnvatinib And Pembrolizumab) clinical program, which is evaluating the combination across 13 different tumor types.

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

The full list of Eisai presentations is included below. All abstracts will be available on demand via the Gastrointestinal Cancers Symposium website from January 15 at 8:00 a.m. EST through January 17.

About LENVIMA (lenvatinib) Capsules

LENVIMA is indicated: For the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-refractory DTC)

In combination with everolimus, for the treatment of patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy

For the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC)

In combination with pembrolizumab, for the treatment of patients with advanced endometrial carcinoma 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. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial

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 (PDGFR), KIT, and RET. In syngeneic mouse tumor models, lenvatinib decreased tumor-associated macrophages, increased activated cytotoxic T cells, and demonstrated greater antitumor activity in combination with an anti-PD-1 monoclonal antibody compared to either treatment alone.

About the Eisai and Merck Strategic Collaboration

In March 2018, Eisai and Merck, 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 monotherapy and in combination with Merck's anti-PD-1 therapy KEYTRUDA.

In addition to ongoing clinical studies evaluating the KEYTRUDA plus LENVIMA 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 20 clinical trials.

About Eisai

Eisai is a leading global research and development-based pharmaceutical company headquartered in Japan, with approximately 10,000 employees worldwide. We define 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, we take 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.

Contact:

Michele Randazzo

Tel: 551-579-4465

Email: michelerandazzo@eisai.com

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