Eisai launched a medium-term business plan “EWAY Future & Beyond” in April 2021. Eisai will endeavor to make steady contributions to patients with goals going forward to accomplish in the medium- to long-term for a pharmaceutical company that develops new drugs in the long-term.
As for research and development under “EWAY Future & Beyond”, through the evolution of biomarkers, we will shift from diagnosis based on symptoms and/or tumors to disease continuum analysis based on pathophysiology, and we will aim for the provision of precision medicine. In the area of oncology, we will aim to achieve early diagnosis based on genome information and realize personalized medicine that enables selection of the optimal treatment method for each patient by obtaining an even deeper understanding of cancer evolution through the continuous DNA analysis of the circulating tumor cells in the bloodstream, and next-generation DNA sequence analysis.
Accelerate Development of Flagship Pipeline in Oncology Areas under Business Group Structure
Eisai has been doing business through business groups, end-to-end organizations that integrate functions from research and development to strategy/planning, in the two major areas of neurology and oncology, since fiscal 2016. One of the objectives of the establishment of business groups is to enhance productivity in business through Early Decision Making. Another is to develop Scientific Acumen, an important organizational culture, through integrated business structure which includes discovery research.
The Oncology Business Group (OBG) will continue to make full use of its technological strength in synthetic chemistry and drug discovery targeting (for molecular targets), which fostered anticancer agents Lenvima and Halaven, to advance new drug development toward a cure for cancer.
Oncology Area–Expanding contribution to patients with Lenvima®
Lenvima® has been approved in more 75 countries and co-commercialization activities with Merck & Co., Inc., Kenilworth, N.J., U.S.A., are progressing smoothly. The clinical studies for the combination therapy of Lenvima and pembrolizumab in 13 different tumor types across more than 20 indications are underway.
Global Phase III studies of the combination therapy of Lenvima® and pembrolizumab of Merck & Co., Inc., Kenilworth, N.J., U.S.A. for advanced endometrial carcinoma in patients with previous treatment1 and advanced renal cell carcinoma (first-line)2 met the primary and secondary endpoints. The combination therapy was approved for these indications in the United States in July and August in 2021, and applications have been submitted in Japan and Europe. Eisai hopes to expand its contribution to patients.
1 advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation
2 first-line treatment of adult patients with advanced renal cell carcinoma