Policy & Regulation
Eisai reveals results from phase two trial of lenvatinib in combination with everolimus
17 February 2020 -

Japan-based research and development-based pharmaceutical company Eisai has revealed results from a phase two trial evaluating the efficacy and safety of lenvatinib (marketed as LENVIMA in combination with everolimus (LEN+EVE) in patients with unresectable advanced or metastatic non-clear cell renal cell carcinoma (NccRCC) at the 2020 Genitourinary Cancers Symposium(#GU20) in San Francisco from February 13-15, it was reported on Saturday.

This single-arm, multicentre, phase two study (Study 221) of lenvatinib (18 mg/day) in combination with everolimus (five mg/day) enrolled 31 patients with unresectable advanced or metastatic NccRCC (papillary, n=20; chromophobe, n=9; unclassified, n=2) who had not received any chemotherapy for advanced disease. The primary endpoint was objective response rate as evaluated by investigators using RECIST 1.1. The secondary endpoints included progression-free survival (PFS) and overall survival (OS).

On primary analysis, the objective response rate was 25.8% (95% Confidence Interval [CI]: 11.9-44.6) with eight patients (papillary, n=three; chromophobe, n=four; unclassified, n=one) having achieved a partial response. 58% (n=18) had stable disease and the clinical benefit rate (CR + PR + durable SD [duration more than 23 weeks]) was 61.3% (95% CI: 42.2-78.2). No patients achieved a complete response. The median duration of response was not reached at the time of data cut-off (17 July 2019).

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