Other efficacy outcome measure: overall survival (OS)1
CI=confidence interval; HR=hazard ratio.
Study 205 randomized 153 patients with advanced or metastatic renal cell carcinoma (RCC) 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 progression-free survival evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Other efficacy outcome measures included OS and objective response rate.
- 25.5 months (95% CI: 16.4-32.1) with LENVIMA + everolimus vs 15.4 months (95% CI: 11.8-20.6) with everolimus alone (HR [95% CI]: 0.67 [0.42-1.08])*
*Analysis was conducted after 63% of deaths had occurred in the LENVIMA + everolimus arm and 74% of deaths had occurred in the everolimus arm.