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    Association details:
    Biomarker:No biomarker
    Cancer:Renal Cell Carcinoma
    Drug:everolimus (mTOR inhibitor) +
    Lenvima (lenvatinib) (c-KIT inhibitor, FGFR inhibitor, VEGFR inhibitor, RET inhibitor, PDGFR α antagonist)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    FDA
    Published date:
    11/10/2020
    Excerpt:
    LENVIMA is a kinase inhibitor that is indicated...In combination with everolimus, for the treatment of patients with advanced renal cell carcinoma (RCC) following one prior antiangiogenic therapy.
    Secondary therapy:
    everolimus
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    Scottish Medicines Consortium
    Title:

    lenvatinib (Kisplyx) is accepted for use within NHSScotland

    Published date:
    10/04/2019
    Excerpt:
    lenvatinib (Kisplyx) is accepted for use within NHSScotland...in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy.
    Secondary therapy:
    everolimus
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    European Medicines Agency
    Published date:
    08/25/2016
    Excerpt:
    In combination with everolimus for the treatment of unresectable advanced or metastatic renal cell carcinoma.
    Secondary therapy:
    everolimus
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    NCCN
    Excerpt:
    Lenvatinib plus everolimus is listed as a category 1, other recommended, subsequent therapy by NCCN Kidney Cancer Panel.
    Secondary therapy:
    everolimus
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Am J Clin Oncol
    Title:

    Phase 3 trial of lenvatinib (LEN) plus pembrolizumab (PEMBRO) or everolimus (EVE) versus sunitinib (SUN) monotherapy as a first-line treatment for patients (pts) with advanced renal cell carcinoma (RCC) (CLEAR study).

    Published date:
    03/02/2021
    Excerpt:
    ...LEN + EVE (median 15 mos) vs SUN (HR 0.65, 95% CI 0.53–0.80)….LEN + EVE (ORR 54%; CR 10%) vs SUN (odds ratio 2.15, 95% CI 1.57–2.93)...LEN + EVE demonstrated significant improvements in PFS and ORR vs SUN.
    Secondary therapy:
    everolimus
    DOI:
    10.1200/JCO.2021.39.6
    Trial ID:
    KEYNOTE-581
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Merck (MSD) Press Release
    Title:

    KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Demonstrated Statistically Significant Improvement in Progression-Free Survival (PFS), Overall Survival (OS) and Objective Response Rate (ORR) Versus Sunitinib as First-Line Treatment for Patients…

    Published date:
    11/10/2020
    Excerpt:
    LENVIMA plus everolimus also met the trial’s primary endpoint of PFS and a key secondary endpoint of ORR, demonstrating a statistically significant and clinically meaningful improvement in PFS and ORR versus sunitinib in the ITT study population.
    Secondary therapy:
    everolimus
    Trial ID:
    KEYNOTE-581
    Evidence Level:
    Sensitive: B - Late Trials
    New
    Source:
    J Clin Oncol
    Title:

    Post hoc analysis of the CLEAR study in advanced renal cell carcinoma (RCC): Effect of subsequent therapy on survival outcomes in the lenvatinib (LEN) + everolimus (EVE) versus sunitinib (SUN) treatment arms.

    Excerpt:
    ...pts in the LEN + EVE arm had a longer median time from randomization to initiation of subsequent therapy vs those in the SUN arm (8.0 vs 6.6 months, respectively)....LEN + EVE met the primary endpoint of a significant benefit in PFS vs SUN.
    DOI:
    10.1200/JCO.2021.39.15_suppl.4562
    Trial ID:
    KEYNOTE-581