Metastatic renal cell carcinoma (mRCC) has a poor prognosis despite recent changes in systemic treatment options. Lenvatinib plus everolimus (LEN+EVE), a combination of 2 targeted therapies, is approved after failure of one prior tyrosine kinase inhibitor (TKI) therapy. Our objective was to evaluate the effectiveness and safety of LEN+EVE therapy in patients with mRCC in a real-world setting.
This retrospective case series included patients with mRCC treatment with LEN+EVE between August 2016 and December 2021 at 6 academic centers in Germany. Outcomes included overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and safety; all evaluated by local investigator. Subgroup analyses by risk scores, previous therapies, and initial dosing were performed.
Eighty-one patients were assessed: median age was 61 years (range 42-80), 81.5% were men, and 80.2% of patients had an ECOG score of 0 or 1. Synchronous metastases were found in 39.5% of patients at initial diagnosis. The International Metastatic RCC Database Consortium (IMDC) risk status was favorable in 16.0%, intermediate in 48.1%, and poor in 16.0% of patients. The median number of treatment lines prior to LEN+EVE was 3 (range 0-7). Median treatment duration with LEN+EVE was 6.1 months (range 0.2-29.2). The ORR was 28.4%, DCR was 61.7%, median OS was 11.3 months (95% CI, 8.7-13.9), and median PFS was 6.5 months (95% CI, 5.4-7.6). Median PFS, OS and ORR were similar across patients with 0-2 versus ≥ 3 previous therapeutic lines and for patients with or without previous immunotherapy. The safety profile was manageable, with 6.2% of patients discontinuing treatment due to treatment-related adverse events.
LEN+EVE combination therapy demonstrated high effectiveness in heavily pre-treated, real-world cohort of patients with mRCC and challenging disease characteristics-regardless of treatment line, IMDC risk group, initial dosing, or previous treatment with immunotherapy.
Clinical genitourinary cancer. 2025 Oct 06 [Epub ahead of print]
Hendrik Eggers, Ramona Stelmacher, Martin Bögemann, Arne Strauß, Christian Thomas, Johannes Landmesser, Stefanie Zschäbitz, Philipp Ivanyi
Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany., Clinic for Medical Oncology, University Hospital Heidelberg, National Cancer Center (NCT) Heidelberg, Heidelberg, Germany., Clinic for Urology and paediatric Urology, University Hospital Muenster, Muenster, Germany., Clinic for Urology, Georg-August-University Medical Center Göttingen, Göttingen, Germany., Clinic for Urology, University Hospital Carl Gustav Clarus, Dresden, Germany., Clinic for Urology, Universityhospital Schleswig Holstein, Campus Lübeck, Lübeck, Germany., Clinic for Medical Oncology, University Hospital Heidelberg, National Cancer Center (NCT) Heidelberg, Heidelberg, Germany; Interdisciplinary Working Party Kidney Cancer of the German Cancer Society (IAGN-DKG)., Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany; Interdisciplinary Working Party Kidney Cancer of the German Cancer Society (IAGN-DKG); Claudia von Schelling Center, Comprehensive Cancer Center Hannover, Hannover, Germany. Electronic address: .