New Delhi, August 04, 2020: Eisai Co., Ltd. and MSD K.K. a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A., announced today that Eisai has submitted an application in Japan for the additional indication of treatment of un resectable thymic carcinoma for multiple receptor tyrosine kinase inhibitor LENVIMA (generic name: lenvatinib mesylate). In June 2020, LENVIMA received orphan drug designation in Japan for unresectable thymic carcinoma.
This application is based on the results of an open-label, single-arm, multicenter, investigator-initiated clinical phase II study (NCCH1508) conducted in Japan, evaluating LENVIMA as a single agent in 42 patients with thymic carcinoma previously treated with at least one platinum-based regimen.
The primary endpoint of this study, Objective Response Rate (ORR, assessed by independent imaging review) was 38.1% (90% confident interval (CI): 25.6-52.0). This study met its endpoint as the lower value of the CI exceeded the pre-specified statistical criteria, a threshold ORR of 10%. The most common three treatment-related adverse events were hypertension (88.1%), proteinuria (71.4%), and palmar-plantar erythrodysesthesia syndrome (69.0%), which is consistent with the safety profile observed in the previously approved indications.
Thymic carcinoma is an extremely rare disease with low prevelance. It is estimated that there are only 140 to 200 patients in Japan. For unresectable thymic carcinoma, platinum-based first-line therapy is recommended. However, since the standard treatment has not yet been established for second-line or later therapy, it remains a disease with a poor prognosis, thus the development of new therapeutic agents is desired.
Eisai and MSD have been collaborating through the provision of information on LENVIMA in Japan since October 2018, and will work together to expedite the maximization of LENVIMA’s contribution to patients with cancer.
Corporate Comm India(CCI Newswire)
