Lenvima approved for additional indication of thymic carcinoma in Japan.-Eisai

Eisai Co., Ltd. and MSD K.K. a subsidiary of Merck & Co., Inc.,announced that Lenvima (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.