EISAI AND MERCK & CO., INC., KENILWORTH, N.J., U.S.A. ANNOUNCE DATA AT 2018 ASCO ANNUAL MEETING FROM INVESTIGATIONAL STUDIES OF LENVIMA® AND KEYTRUDA® COMBINATION THERAPY IN FOUR DIFFERENT TUMOR TYPES
● First presentation of LENVIMA/KEYTRUDA data in patients with unresectable hepatocellular carcinoma (HCC), which aims to be the first systemic combination of a TKI and immunotherapy for these patients, as well as squamous cell carcinoma of the head and neck (SCCHN)
● Updated results show antitumor activity with a consistent safety profile in advanced renal cell carcinoma (RCC) and advanced endometrial carcinoma (EC)
● The LENVIMA/KEYTRUDA combination was recently granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for advanced RCC
● Phase III trials underway in advanced RCC (NCT02811861) and advanced EC (NCT03517449)
● Updated results show antitumor activity with a consistent safety profile in advanced renal cell carcinoma (RCC) and advanced endometrial carcinoma (EC)
● The LENVIMA/KEYTRUDA combination was recently granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for advanced RCC
● Phase III trials underway in advanced RCC (NCT02811861) and advanced EC (NCT03517449)
TOKYO Jun 4, 2018 – Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada), announced today that results from presentations of new data and analyses of LENVIMA® (lenvatinib), an orally available kinase inhibitor discovered by Eisai, in combination with Merck & Co., Inc., Kenilworth, N.J., U.S.A.’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in four different tumor types: unresectable hepatocellular carcinoma (HCC) (Abstract #4076), squamous cell carcinoma of the head and neck (SCCHN) (Abstract #6016), advanced renal cell carcinoma (RCC) (Abstract #4560), and advanced endometrial carcinoma (EC) (Abstract #5596 and Abstract #5597). The data are included in presentations at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from June 1-5. LENVIMA and KEYTRUDA are not approved for use in combination in any cancer types today.
“The data we have observed in the combination studies of LENVIMA plus KEYTRUDA have fueled our commitment to help meet the diverse health care needs of patients living with cancer through clinical studies and research in specific tumor types that are notoriously difficult to treat and continue to have a significant need for new therapeutic options,” said Alton Kremer, MD, PhD, Chief Clinical Officer and Chief Medical Officer, Oncology Business Group at Eisai. “We are pleased to share the activity observed in clinical studies of the LENVIMA plus KEYTRUDA combination, as well as rationale for the combination in advanced endometrial carcinoma through translational research.”
“With these data at ASCO, we are continuing to see encouraging overall response rates, as well as a safety profile that supports the scientific rationale of adding LENVIMA to KEYTRUDA,” said Dr. Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, Merck & Co., Inc., Kenilworth, N.J., U.S.A. “These findings add to the growing body of evidence showing the potential of this combination regimen across a number of tumor types and underscore the strategy behind our collaboration with Eisai.”
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.