Major efficacy outcome measure: progression-free survival (PFS)1
CI=confidence interval; HR=hazard ratio.
Study 205 randomized 153 patients with advanced or metastatic renal cell carcinoma who had previously received anti-angiogenic therapy 1:1:1 to LENVIMA 18 mg + everolimus 5 mg, LENVIMA 24 mg monotherapy, or everolimus 10 mg monotherapy. All medications were administered orally once daily. Patients were required to have histological confirmation of clear cell RCC and Eastern Cooperative Oncology Group performance status of 0 or 1. Patients were stratified by hemoglobin level (≤13 g/dL vs >13 g/dL for males and ≤11.5 g/dL vs >11.5 g/dL for females) and corrected serum calcium (≥10 mg/dL vs <10 mg/dL). The major efficacy outcome measure was investigator-assessed PFS evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Other efficacy outcome measures included overall survival and objective response rate.
- 14.6 months (95% CI: 5.9-20.1) with LENVIMA + everolimus vs 5.5 months (95% CI: 3.5-7.1) with everolimus alone (HR [95% CI]: 0.37 [0.22-0.62])
- 26 events (51%) occurred in the LENVIMA + everolimus arm vs 37 events (74%) in the everolimus arm
- 21 patients (41%) who received LENVIMA + everolimus progressed vs 35 patients (70%) who received everolimus
- Death occurred in 5 patients (10%) who received LENVIMA + everolimus vs 2 patients (4%) who received everolimus
- The treatment effect of LENVIMA + everolimus on PFS was supported by a retrospective, independent review of radiographs with an observed HR of 0.43 (95% CI: 0.24-0.75) compared with the everolimus arm