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Agreements

Date: 2015-03-04

Type of information: Clinical research agreement

Compound: Keytruda® (pembrolizumab), Lenvima® (lenvatinib) and Halaven® (eribulin)

Company: Eisai (Japan) Merck&Co (USA - NJ)

Therapeutic area: Cancer - Oncology

Type agreement:

clinical research

Action mechanism:

tyrosine kinase inhibitor. Lenvima®, discovered and developed by Eisai, is an oral molecular targeted agent that selectively inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors (VEGFR1 (FLT1), VEGFR2 (KDR) and VEGFR3 (FLT4)), and fibroblast growth factor (FGF) receptors FGFR1, 2, 3 and 4 in addition to other proangiogenic and oncogenic pathway-related RTKs (including the platelet-derived growth factor (PDGF) receptor PDGFRα; KIT; and RET) involved in tumor proliferation. In particular, Lenvima® possesses a new binding mode (Type V) to VEGFR2, as confirmed through X-ray crystal structural analysis, and exhibits rapid and potent inhibition of kinase activity, according to kinetic analysis.

microtubule inhibitor. Halaven® is a halichondrin class microtubule dynamics inhibitor with a novel mechanism of action. It belongs to a class of antineoplastic agents, the halichondrins, which are natural products isolated from the marine sponge Halichondria okadai. It is believed to work by inhibiting the growth phase of microtubule dynamics without affecting the shortening phase and sequestering tubulin into nonproductive aggregates.

monoclonal antibody. Keytruda® (pembrolizumab) is a humanized monoclonal antibody that blocks the interaction between PD-1 (programmed death receptor-1) and its ligands, PD-L1 and PD-L2. 

Disease: metastatic triple-negative breast cancer

Details:

* On March 4, 2015, Eisai and Merck&Co announced a clinical trial collaboration to evaluate the safety, tolerability and efficacy of Merck’s anti-PD-1 therapy Keytruda® (pembrolizumab), in combination with Eisai\'Lenvima® (lenvatinib) and Halaven® (eribulin) in multiple clinical trials. The planned studies include a multicenter, open-label Phase 1b/2 study of lenvatinib plus pembrolizumab in select solid tumors and an open-label, single-arm, multicenter Phase 1b/2 study to evaluate the efficacy and safety of eribulin in combination with pembrolizumab in metastatic triple-negative breast cancer. Eisai and Merck will establish a Joint Development Committee to oversee clinical development activities. The studies are expected to begin in the second half of 2015. Financial terms of the agreement were not disclosed.

Financial terms:

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