Japan – Lenvima (Lenvatinib) Approved for Additional Indication of Unresectable Thymic Carcinoma in Japan
Eisai Co., Ltd. and MSD K.K., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A., announced today that LENVIMA (generic name: lenvatinib mesylate), the multiple receptor tyrosine kinase inhibitor discovered by Eisai, has been approved in Japan for the additional indication of treatment of unresectable thymic carcinoma. This marks the first approval for LENVIMA for unresectable thymic carcinoma in Japan.
The approval was based on the results of an open-label, single-arm, multicenter, investigator-initiated clinical phase II study (REMORA study) conducted in 8 centers across Japan including the National Cancer Center Hospital, evaluating LENVIMA as a single agent in 42 patients with thymic carcinoma previously treated with at least one platinum-based regimen.
LENVIMA met the study’s primary endpoint of objective response rate (ORR) as assessed by independent imaging review, demonstrating an ORR of 38.1% (90% confidence interval (CI): 25.6-52.0). The lower value of the CI exceeded the pre-specified statistical criteria with 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 prevalence. It is estimated that there are about 140 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, this is an area of high unmet medical need. In June 2020, LENVIMA received orphan drug designation in Japan for unresectable thymic carcinoma.
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.
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